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Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in MSI-H or dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment with a Fluoropyrimidine, Oxaliplatin, and Irinotecan
By Business Wire, August 01, 2017, 06:59:00 AM EDT
Approval based on CheckMate -142, in which Opdivo demonstrated an objective response rate of 28% (95% CI: 17-42; 15/53) among patients who received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan1,2
PRINCETON, N.J.--(BUSINESS WIRE)--
Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection for intravenous use for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.2 Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The recommended dose is 240 milligrams administered as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity.2 In the CheckMate -142 trial, among patients (53/74) who received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, 28% (95% CI: 17-42; 15/53) responded to treatment with Opdivo. The percentage of patients with a complete response was 1.9% (1/53) and the percentage of patients with a partial response was 26% (14/53). Among these responders, the median duration of response was not reached (range: 2.8+-22.1+ months).2 Among all enrolled patients, 32% (95% CI: 22-44; 24/74) responded to treatment with Opdivo; 2.7% (2/74) experienced a complete response, 30% (22/74) experienced a partial response.2
Opdivo is associated with the following Warnings and Precautions including immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis, other adverse reactions; infusion reactions; and embryo-fetal toxicity.2 Please see the Important Safety Information section below.
"As part of our commitment to address hard-to-treat cancers, with today's approval, Opdivo provides a new treatment option for these patients who have historically faced a poor prognosis,"3,4,5 said Chris Boerner, president, U.S. Commercial, Bristol-Myers Squibb. "This approval is one example of how our commitment to translational medicine and investigating predictive biomarkers may help us discover treatment approaches to address different patients' unique needs."
"Patients with metastatic colorectal cancer who have dMMR or MSI-H tumors are less likely to respond to conventional chemotherapy,"3,4,5 said Heinz-Josef Lenz, M.D., FACP, J. Terrence Lanni Chair in Gastrointestinal Cancer Research, University of Southern California. "While the challenges of treating these patients have been significant, tumors characterized by these biomarkers are immunogenic.3,6 Therefore, advances in immunotherapy research are encouraging in presenting new treatment options for appropriate patients with MSI-H metastatic colorectal cancer."
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend universal MMR or MSI testing for all patients with a personal history of colon or rectal cancer to inform use of immunotherapy in patients with metastatic disease. The National Comprehensive Cancer Network® (NCCN®) panel recommends nivolumab (OPDIVO) as a category 2A treatment option in patients with metastatic deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer in second- or third-line therapy.7
Approval Based on Notable Tumor Response Rate and Duration of Response
CheckMate -142 is a Phase 2, multicenter, open-label, single-arm study evaluating Opdivo in patients with locally determined dMMR or MSI-H mCRC whose disease had progressed during, after, or were intolerant to, prior treatment with fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy.1,2 In this study, 74 patients received Opdivo 3 mg/kg administered intravenously every two weeks.2 The recommended dose is 240 mg administered as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity.2 Across the 74 patients, 72% received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.2 Efficacy outcome measures included independent radiographic review committee-assessed confirmed ORR per RECIST 1.1, and duration of response.2 More than half of patients (51%) had a BRAF (16%) or KRAS (35%) mutation.1
In this trial, Opdivo demonstrated an ORR of 28% (95% CI: 17-42; 15/53) in patients who received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, including a 1.9% complete response rate (1/53) and a 26% partial response rate (14/53). Median duration of response in these patients was not reached(range: 2.8+-22.1+ months).2 Among all enrolled patients, 32% (95% CI: 22-44; 24/74) responded to treatment with Opdivo, including a 2.7% complete response rate (2/74) and a 30% partial response rate (22/74). The median duration of response was not reached (range: 1.4+-26.5+ months).2 Data from CheckMate -142 were published in The Lancet Oncology in July.
"As the third most common type of cancer in the United States, our view is that colorectal cancer - particularly for those with dMMR or MSI-H metastatic disease - has been in need of new research and treatments.8 The approval of Opdivo for appropriate patients with this disease gives the community more hope," said Michael Sapienza, chief executive officer of the Colon Cancer Alliance.
Select Safety Profile
The most common adverse reactions (≥20%) in patients who received Opdivo as a single agent were fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia.2 Please see additional Important Safety Information below.
About dMMR or MSI-H Colorectal Cancer
Colorectal cancer (CRC) is cancer that develops in the colon or the rectum, which are part of the body's digestive or gastrointestinal system.9 In the United States, CRC is the third most common cancer, in 2017 it is estimated that there will be approximately 135,000 new cases of the disease and that it will be the second leading cause of cancer-related deaths among men and women combined.8,10 Approximately 5% of metastatic CRC patients have mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) tumors.3
Mismatch repair deficiency occurs when the proteins that repair mismatch errors in DNA replication are missing or non-functional, which leads to MSI-H tumors in certain types of cancer, including CRC.5,11 Patients with dMMR or MSI-H metastatic CRC are less likely to benefit from conventional chemotherapy and typically have a poor prognosis.3,4,5 Routine testing to confirm dMMR or MSI-H status should be conducted for all metastatic CRC patients.7
INDICATION
OPDIVO® (nivolumab) is indicated for the treatment of adults and pediatric (12 years and older) patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
IMPORTANT SAFETY INFORMATION
Immune-Mediated Pneumonitis
OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients.
Immune-Mediated Colitis
OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients.
Immune-Mediated Hepatitis
OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 immune-mediated hepatitis.. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients.
Immune-Mediated Endocrinopathies
OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.
In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients.
Immune-Mediated Nephritis and Renal Dysfunction
OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients.
Immune-Mediated Skin Adverse Reactions
OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients.
Immune-Mediated Encephalitis
OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids.
Other Immune-Mediated Adverse Reactions
Based on the severity of adverse reaction, permanently discontinue or withhold treatment, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Across clinical trials of OPDIVO the following clinically significant immune-mediated adverse reactions occurred in <1.0% of patients receiving OPDIVO: uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain Barré syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), myositis, myocarditis, rhabdomyolysis, motor dysfunction, vasculitis, and myasthenic syndrome.
Infusion Reactions
OPDIVO can cause severe infusion reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. In patients receiving OPDIVO monotherapy, infusion-related reactions occurred in 6.4% (127/1994) of patients.
Embryo-Fetal Toxicity
Based on its mechanism of action, OPDIVO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with an OPDIVO- containing regimen and for at least 5 months after the last dose of OPDIVO.
Lactation
It is not known whether OPDIVO is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from an OPDIVO-containing regimen, advise women to discontinue breastfeeding during treatment.
Common Adverse Reactions
The most common adverse reactions (≥20%) in patients who received OPDIVO as a single agent were fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia.2
Please see U.S. Full Prescribing Information for OPDIVO
About the Opdivo Clinical Development Program
Bristol-Myers Squibb's global development program founded on scientific expertise in the field of Immuno-Oncology includes a broad range of clinical trials studying Opdivo, across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients.
About Bristol-Myers Squibb's Patient Access Support
Bristol-Myers Squibb remains committed to providing a comprehensive set of programs and services so that cancer patients who need our medicines can access them and expedite time to therapy.
BMS Access Support®, the Bristol-Myers Squibb Patient Access and Reimbursement Services program, is designed to help appropriate patients initiate and maintain access to BMS medicines during their treatment journey. BMS Access Support offers benefit investigation, prior authorization assistance and co-pay assistance for eligible, commercially insured patients. More information about our access and reimbursement support services can be obtained by calling BMS Access Support® at 1-800-861-0048 or by visiting www.bmsaccesssupport.com.
About the Bristol-Myers Squibb and Ono Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 2014, Ono and Bristol-Myers Squibb further expanded the companies' strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies - as single agents and combination regimens - for patients with cancer in Japan, South Korea and Taiwan.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2016 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
References
1. Data on file. NIVO 287. Princeton, NJ: Bristol-Myers Squibb.
2. Opdivo Prescribing Information. Opdivo U.S. Product Information. Last updated: July 31, 2017. Princeton, NJ: Bristol-Myers Squibb Company.
3. Venderbosch S, Nagteagaal ID, Maughan TS, et al. Mismatch repair status and BRAF mutation status in metastatic colorectal cancer patients: A pooled analysis of the CAIRO, CAIRO2, COIN, and FOCUS studies. Clin Cancer Res. 2014;20:5322-5330.
4. Müller CI, Schulmann K, Reinacher-Schick A, et al. Predictive and prognostic value of microsatellite instability in patients with advanced colorectal cancer treated with a fluoropyrimidine and oxaliplatin containing first-line chemotherapy. A report of the AIO Colorectal Study Group. Int J Colorectal Dis. 2008;23:1033-1039
5. Koopman M, Kortman G, Mekenkamp L, et al. Deficient mismatch repair system in patients with sporadic advanced colorectal cancer. Brit J Cancer. 2009;100:266-273.
6. Llosa NJ, Cruise M, Tam A, et al. The vigorous immune microenvironment of microsatellite instable colon cancer is balanced by multiple counter-inhibitory checkpoints. Cancer Discov. 2015;5(1):43-51
7. Benson AB 3rd, Venook AP, Cederquist L, et al. Colon Cancer, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2017;15(3):370-398.
8. American Cancer Society. Colorectal Cancer Facts & Figures 2017-2019. Atlanta: American Cancer Society; 2017.
9. American Cancer Society. Key Statistics for Colorectal Cancer. https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html. Accessed March 9, 2017.
10. National Cancer Institute. Cancer Stat Facts: Colon and Rectum Cancer. Surveillance, Epidemiology, and End Results Program. https://seer.cancer.gov/statfacts/html/colorect.html. Accessed March 9, 2017.
11. Yacoub, George, Srikanth Nagalla, Mebea Aklilu. Oncologic Management of Hereditary Colorectal Cancer. Clin Colon Rectal Surg. 2012;25:118-122.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170801005540/en/
Source: Bristol-Myers Squibb Company
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BMY
Understood -- posted it as a reminder and not a hype. Actually it really means that BMY has a certain numbers of priority reviews in their portfolio and have chosen to use one of them here to facilitate obtaining the meeting.
BMY
U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Previously Treated dMMR or MSI-H Metastatic Colorectal Cancer
Application based on results from Phase 2 CheckMate -142 study
April 04, 2017 04:15 PM Eastern Daylight Time
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) that seeks to extend the use of Opdivo (nivolumab) to patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC) after prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. The FDA granted the application priority review, and the FDA action date is August 2, 2017.
http://www.businesswire.com/news/home/20170404006413/en/U.S.-Food-Drug-Administration-Accepts-Priority-Review
BMY
Bristol-Myers and Clovis to evaluate Opdivo/Rubraca combo in range of tumors; Clovis down 6% premarket
Jul. 31, 2017 7:44 AM ET|About: Bristol-Myers Squibb C... (BMY)|By: Douglas W. House, SA News Editor
Bristol-Myers Squibb (NYSE:BMY) and Clovis Oncology (NASDAQ:CLVS) ink a clinical collaboration agreement to evaluate the combination of PD-1 inhibitor Opdivo (nivolumab) and PARP inhibitor Rubraca (rucaparib) across multiple tumor types.
Phase 3 studies will be conducted in advanced ovarian cancer and advanced triple-negative breast cancer. The partnership will also include a Phase 2 clinical trial in metastatic castration-resistant prostate cancer.
Clovis will sponsor and run the ovarian cancer trial while Bristol-Myers will be responsible for the prostate cancer and breast cancer studies. All three should commence before year-end.
CLVS is down 6% premarket on modestly higher volume. Shares rallied over 15% last week as investors were anticipating good news, possibly a buyout.
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https://seekingalpha.com/news/3283265-bristol-myers-clovis-evaluate-opdivo-rubraca-combo-range-tumors-clovis-6-percent-premarket?app=1&uprof=46#email_link
BMY
Bullish SA article from several weeks ago:
Neos Therapeutics: All Angles Covered For PDUFA
Jul. 14, 2017 9:57 AM ET|7 comments| About: Neos Therapeutics (NEOS), Includes: SHPG
Avisol Capital Partners
(331 followers)
Summary
Neos is a small company developing generic drugs.
Its past experience with the FDA gave it hindsight to approach the next PDUFA properly.
We believe there is now considerable upside from current levels.
By S. Mitra, MBA (ISB)
Neos Therapeutics (NEOS) looks more and more like a very good mid-term investment before the September PDUFA. It is a small company with just a $176mn market cap and yet has an existing revenue stream in the form of two revenue-generating products in the market. A third product, Cotempla XR-ODT, just got approved by the FDA in June, and should be in the market later this year. All these recent products target the large ADHD or Attention Deficit Hyperactivity Disorder market, and uptake and even treatment switching has been good so far. The products have a long patent runway extending to 2032. Recently revised guidance from the FDA regarding more stringent generic bioequivalence standards have also considerably limited competition. Finally, NT-0201, the company’s amphetamine XR liquid suspension, will have a PDUFA in September, providing an important catalyst for the company.
Considering all the above positives, we took a position in the stock yesterday at around $6.50. This is the third time in the last 12 months we have played this stock on a catalyst. The other two times worked out pretty well so we expect nothing less from the next PDUFA catalyst.
There are a number of reasons NT-0201 should succeed with the PDUFA. Principally, this is because the company now has a lot more hindsight from its previous interactions with the FDA. Recall how the company received a CRL in November 2015 because the FDA required a bridging study for the company’s Cotempla XR-ODT product? The bridging study involved showing bioequivalence between the clinical and the commercial versions of the product, including food effect assessment and validation and three month’s stability data. This time round, with NT-0201, the company has already completed the bridging study and a bioequivalence study with the listed drug. As it says in its latest 10-K:
In addition to the clinical trial program outlined below, we conducted two additional bioequivalence studies for NT-0201, in support of the NDA: a bridging study of our clinical trial material and our to-be-marketed drug material, which examined the effect of a high-fat meal on the commercial formulation, and a bioequivalence study of the commercial formulation versus Adderall XR 30 mg.
The bioequivalence study clearly showed that the commercial scale formulation of NT-0201 is bioequivalent to the listed drug, Adderall XR, 30 mg, under fasted condition. As you can see below, the mean-concentration graphs are almost overlapping at every time point.
Source - 10-K
The study also showed that there is no significant food effect, that there was a similar exposure rate in children with a higher mean which decreased with age, just as with Adderall, and also that the safety and tolerability profiles of the two drugs were equivalent.
Armed with this data, the company submitted the NDA on November 15, 2016, so the expected PDUFA date is September 15, 2017.
Another important angle with NT-0201 is that Neos has managed to come to an arrangement with the maker of the listed drug, Shire Pharmaceuticals (SHPG), which lets Neos pay a one time lump sum license fee of less than $1mn and single digit royalties against Shire’s agreement not to file any patent infringement suit against Neos. As we know quite well, launch of a generic product is fraught with the hurdles of patent infringement lawsuits; this agreement effectively nips that problem at the bud.
Overall, we have a good feeling about this upcoming PDUFA and think that NEOS has covered its back very well, taking stock of all possible debacles that could happen, and pre-emptively addressing them all. So, we are betting big on the PDUFA. We do, however, expect another dilution right after, despite its recent $32mn June secondary. The company had about $50 million in cash as of March, and despite the addition of the $32mn, it will still need more cash for the two product launches this year. So, we expect a dilution on good news, and our strategy will be to “rinse and repeat” the stock around the PDUFA and perhaps again enter a small position post a dilution, if any, which we will hold longer term in expectation of positive market uptake sometime by the middle of 2018.
Disclosure: I am/we are long NEOS.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
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https://seekingalpha.com/article/4087726-neos-therapeutics-angles-covered-pdufa
NEOS
Bristol-Myers Squibb (BMY) Q2 2017 Results - Earnings Call Transcript
Jul. 27, 2017 6:39 PM ET| About: Bristol-Myers Squibb Company (BMY)
Q2: 07-23-17 Earnings Summary
EPS of $0.74 Revenue of $5.14B (+ 5.5% Y/Y) beats by $50M
Bristol-Myers Squibb Co. (NYSE:BMY)
Q2 2017 Earnings Call
July 27, 2017 10:30 am ET
Executives
John E. Elicker - Bristol-Myers Squibb Co.
Giovanni Caforio - Bristol-Myers Squibb Co.
Charles A. Bancroft - Bristol-Myers Squibb Co.
Thomas J. Lynch, Jr., M.D. - Bristol-Myers Squibb Co.
Murdo Gordon - Bristol-Myers Squibb Co.
Analysts
Jami Rubin - Goldman Sachs & Co. LLC
Chris Schott - JPMorgan Securities LLC
Vamil K. Divan - Credit Suisse Securities (NYSE:USA) LLC
Gregg Gilbert - Deutsche Bank Securities, Inc.
Timothy Minton Anderson - Sanford C. Bernstein & Co. LLC
Umer Raffat - Evercore Group LLC
Seamus Fernandez - Leerink Partners LLC
Andrew S. Baum - Citigroup Global Markets Ltd.
Steve Scala - Cowen & Co. LLC
David R. Risinger - Morgan Stanley & Co. LLC
Geoff Meacham - Barclays Capital, Inc.
Marc Goodman - UBS Securities LLC
Tony Butler - Guggenheim Securities LLC
Operator
Good day, and welcome to the Bristol-Myers Squibb 2017 Second Quarter Results Conference Call. Today's conference is being recorded.
At this time, I'd like to turn the conference over to Mr. John Elicker, Senior Vice President, Public Affairs and Investor Relations. Please go ahead, sir.
John E. Elicker - Bristol-Myers Squibb Co.
Thank you, Hannah, and good morning, everybody, and thanks for joining our call to discuss our second quarter earnings. With me this morning are, Giovanni Caforio, our Chief Executive Officer, Charlie Bancroft, our Chief Financial Officer. Both Giovanni and Charlie will have prepared remarks. Also joining are Murdo Gordon, our Chief Commercial Officer, and Tom Lynch, our Chief Scientific Officer, who, obviously, will be here for Q&A.
And before I turn it over to Giovanni, I'll read the Safe Harbor language. During the call, we'll make statements about the company's future plans and prospects that constitute forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the company's SEC filings.
These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date. We specifically disclaim any obligation to update forward-looking statements, even if our estimates change. We'll focus our comments on our non-GAAP financial measures which are adjusted to exclude certain specified items. Reconciliations of these non-GAAP measures to the most comparable GAAP measures are available at our website.
Giovanni?
Giovanni Caforio - Bristol-Myers Squibb Co.
Thank you, John. Good morning, everyone. I'm really pleased that we just finished another strong quarter. Our non-GAAP earnings per share was $0.74, which is a 7% increase over last year. And we grew our revenue by 6% with double-digit growth across our key growth drivers. Now, before I go into more detail, we all know that a competitor announced data this morning that is clearly important to the market. So let me make a few comments.
First, our CheckMate 227 is a first-line, non-small cell lung cancer program, not just one trial, investigating several important scientific questions. In study 227 we have at least three discrete opportunities for success. We will be able to evaluate the combination of Opdivo plus Yervoy, we will evaluate Opdivo plus chemo in PDL-1 negative patients and we will be available to evaluate Opdivo plus chemo in all comers. Additionally, as you know, we are testing two cycles of chemo with the combination of Opdivo and Yervoy.
It's also important to recognize that MYSTIC trial and CheckMate 227 are very different trials. First, the dose and schedules are different. In 227, we believe we have optimized the dose and the schedule. Second, the trial sizes are very different. 227 enrolled over 2,200 patients, with 1,200 patients in the PDL-1 positive portion alone. In contrast, MYSTIC enrolled roughly 1,100 patients in all comers, and its primary endpoint was evaluated in a subset of that population. While the MYSTIC results are important data and we look forward to seeing more, it's very difficult to read across trials.
So let me now get back to our results this quarter. Globally, Opdivo sales were very strong. In the U.S. Opdivo delivered strong performance in an increasingly competitive market. Shares in the second-line lung cancer market remained stable, and we saw continued strong performance in other tumor types, with oncology trends in head and neck cancer. Internationally, we delivered very strong growth, as we leveraged broad reimbursement and strong commercial execution to drive continued adoption in our key markets. We also saw important progress from a regulatory and from a clinical perspective.
Earlier this month, we announced results from CheckMate 238, which was stopped early as Opdivo demonstrated superior recurrence-free survival in the adjuvant setting of melanoma versus Yervoy, the current standard of care in this setting. This is another successful registrational trial with Opdivo, and it's an important validation of our strategic approach to moving treatment earlier in the adjuvant setting, which we are exploring across tumors.
In Europe, Opdivo achieved two important approvals, one in head and neck cancer and one in advanced bladder cancer. In the U.S., the FDA accepted for Priority Review our application for second-line hepatocellular carcinoma, the most common type of liver cancer, and we have a PDUFA date of September 24. You saw that we just filed the sBLA for four-week dosing for Opdivo monotherapy and we look forward to making that dosing available to patients and physicians.
ASCO is always an important Meeting for us. From my perspective, there were two key themes at this year's Meeting. First, we saw the emergence of the next wave of immune-oncology agents that have the potential to complement validated mechanisms, such as PD-1 and CTLA-4. Assets like LAG-3 and IDO underscore the potential of our R&D pipeline and our expertise in this area.
Second, it was clear that translational research in biomarkers are likely to play a critical role in identifying which patients will benefit most from different therapies or regimen. This work is important because we know that the unmet need in cancer remains high and that there are many patients we are not reaching. And we believe our pipeline of I-O assets positions us well to bring forward the right medicine or regimen for the right patient at the right time.
Looking forward over the next 12 months or so, we have important data readouts expected from our portfolio, including in renal cancer, HCC, small cell lung cancer and, of course, non-small cell lung cancer. Outside of oncology, execution also continues to be strong. Eliquis delivered 51% growth, continuing to expand its lead in the expanding NOAC class. Our hepatitis C regimen was approved and recently launched in China, making it the first regimen of its kind in this important market. Orencia product sales remains strong, having again delivered double-digit growth.
We also saw continued progress in our diversified portfolio from a regulatory and from a clinical perspective. We've made good progress on FGF21, where we are in discussion with health authorities about our registrational program which we intend to start by the end of this year. Orencia received approval for psoriatic arthritis in the U.S. and in Europe, and we expect 2018 to be an important year for our immuno-science pipeline, with potential data readouts for the T2 and the BTK programs.
Finally, following our IP settlement with Merck earlier this year, together with our partner owner, we've just taken additional legal action against a number of companies with commercialized PD-L1 products. As we've said before, we have established a strong IP position with respect to anti-PD-1 and anti-PD-L1 that we will vigorously defend. Similar to the Merck action, we are seeking financial remedy, and not to reduce patient access to these medicines. As the innovators in this field, we have made significant investments in developing the science of IO, and we are proud of the transformative benefits it is bringing to cancer.
As I look back at the first half of the year, I'm very pleased with the execution across the company. We've reported strong sales performance and we have seen good progress from a regulatory perspective and from a clinical perspective. Looking ahead, I see tremendous opportunity for us to continue our growth and I am confident that we are very well-positioned for the long term.
And with that, I'll turn it over to Charlie. Thank you.
Charles A. Bancroft - Bristol-Myers Squibb Co.
Good morning, everyone. As Giovanni described, we delivered strong results during the quarter driven by solid execution across the company. Let me first provide some color on the performance of our key products, starting with Opdivo. During the quarter, we saw continued growth for Opdivo in the U.S., with a year-over-year increase of 19%. We're very pleased with this performance, particularly given the increased competition in the market across the range of approved indications.
Specifically, in second-line lung cancer, we maintained roughly 40% share as we exited Q2. Outside of lung cancer in the U.S., the trends in renal cell remain strong with approximately 50% share, and we are seeing early signs of acceleration in head and neck. Given the current trends and strength of our business in the first half of the year, we believe that Opdivo will grow in the U.S. compared to 2016, despite pressure in the second half of this year due to the competitive dynamics in both first and second-line lung cancer.
Internationally, sales of Opdivo were up 17% sequentially as we continue to see adoption across second-line, non-small cell lung cancer and renal. Outside of these tumors, we are in the process of launching Opdivo in head and neck and bladder in several markets where we already have secured reimbursement, including Germany, Belgium and the Netherlands.
With respect to the combination of Opdivo and Yervoy in melanoma, in the U.S., share for the combination remains stable, with use in roughly one-third of first-line patients. Internationally, access and reimbursement approvals for the combination facilitated greater adoption, resulting in 24% year-over-year growth in Yervoy sales.
As Giovanni mentioned, Eliquis delivered strong growth and is leading new-to-brand share in both the NOAC and OAC class. Given the strength of our data, including the real-world outcomes data presented over the last two years, we believe we have significant opportunity for continued growth. Internationally, Eliquis delivered strong growth of 42% compared to the same time last year and continued to outpace the growth of the NOAC class in key markets around the world. Eliquis is the number-one NOAC in new-to-brand share in countries such as Germany, France and the U.K.
Orencia and SPRYCEL delivered worldwide double-digit growth year-on-year as we continue to drive demand growth for Orencia in the early, rapidly-progressing patient segment of RA. With respect to SPRYCEL, our first-line new patient share remains strong.
Now I'd like to highlight a couple of items from our non-GAAP P&L. As I've described in the past, our gross margin is sensitive to product mix. During the quarter, we saw continued growth in Eliquis and declining performance from our virology portfolio, together pressuring our margin.
With respect to operating expenses in the quarter, SG&A was down 6% while R&D was up 5%. This dynamic reflects our commitment to strategically manage our expenses to ensure we can invest in the most important opportunities for our company, with R&D as a key priority.
Just a couple comments on capital allocation. Business development remains a top priority and the second quarter was very active. We executed multiple transactions, including collaborations to expand our biomarker science in I-O with QIAGEN and to study potentially registrational clinical collaborations in combination with Opdivo. In addition, we completed the $2 billion ASR during the quarter and, as I previously outlined, we plan to conduct additional share purchases during the second half of the year at roughly $250 million per quarter.
Turning to guidance. Given the strength of our business in the first half of 2017, we are raising the floor on our non-GAAP EPS and are now guiding to $2.90 to $3.
In closing, we believe our marketed portfolio and pipeline have significant potential. We've delivered very solid results in the first half of the year based on strong execution across the company, and we will continue to focus on investing in the highest priority opportunities across the portfolio.
I'll now turn it back to John for Q&A.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks, Charlie; and thanks, Giovanni, for the comments. Hannah, I think we're ready to go to the Q&A.
Question-and-Answer Session
Operator
Thank you. And we'll take our first question from Jami Rubin with Goldman Sachs.
Jami Rubin - Goldman Sachs & Co. LLC
Thank you. Tom, I have a question for you. And, Giovanni, I appreciate your spelling out the differences between the MYSTIC trial and CheckMate -227. But, Tom, just curious to know your level of confidence in just the general CTLA-4 thesis in light of the MYSTIC results.
I note that there are a couple of other really important front-line studies with Yervoy and Opdivo that could report later this year renal and next year head and neck. If you could comment generally about the role of CTLA-4 and your confidence in this asset. It's very hard to walk away from MYSTIC feeling warm and fuzzy about 227. So I'm just wondering if you could talk big picture about that particular strategy. Thanks very much.
Thomas J. Lynch, Jr., M.D. - Bristol-Myers Squibb Co.
Well, Jami, thanks so much for your question. And what I'd like to do is start off by making a couple comments about lung cancer in general and then address specifically the thoughts about CTLA-4 because I do think it's an important data to emphasize how we look at CTLA-4.
So as I've said many times, Jami, lung cancer is an unbelievably difficult disease to treat. I've been at it for 30 years and I continually am struck by how challenging it is to make progress in this disease. I think as Giovanni outlined in his comments, one of the key things about Bristol-Myers is we have a comprehensive program in lung cancer.
We're not wedded to any one approach. We have optionality with monotherapy in first-line. We have combination of Opdivo and Yervoy in first-line lung cancer. We also have Opdivo-Yervoy combined with chemotherapy, as well Opdivo combined with chemotherapy in first-line lung cancer. So study 227, along with its new cousin, study LA-9 (sic) [9LA], are really a family of studies that we hope are going to demonstrate what the best opportunity in lung cancer is in the first-line.
So let me just comment on CTLA-4 as a mechanism. As an oncologist, what really matters to me are drugs that impact overall survival. And CTLA-4 is one of the two drugs in immuno-oncology that has been shown to impact overall survival. And let's just think about it. In Phase III we had data this year that shows in melanoma that Opdivo and Yervoy has a survival advantage in patients with melanoma.
The NCCN has endorsed the combination therapy in small cell lung cancer and in mesothelioma. We have Phase II studies that shows strong signals in renal cell cancer and MSI-high colorectal cancer. And, again, in the next 12 months, you're going to be seeing nearly five large Phase III trials where we're looking at CTLA-4 plus Opdivo in renal cell cancer, head and neck cancer and small cell cancer in addition to what we were talking about in non-small cell lung cancer.
So we believe that CTLA-4 is an important mechanism. In fact, Jami, not only do we think that Yervoy itself is important, but we've also invested in a non-fucosylated new formation of CTLA-4 and we're partnering with CytomX to look at a Probody for CTLA-4. So I think as an oncologist, as a clinical researcher, when you see an agent that's associated with a survival advantage, I think it's important to find out what is the optimal way to use this drug and how can we improve outcome for our patients.
And one of the things that we've become very aware of is dose and schedule are important when you combine I-O/I-O drugs. And I think that we feel, certainly in 227, that we have a good dose and schedule for our patients.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks for the question, Jami. Hannah, can we go to the next question, please?
Operator
We'll go next to Chris Schott with JPMorgan.
Chris Schott - JPMorgan Securities LLC
Great. Thanks very much. And just a couple additional follow-ups given the MYSTIC update. So just a couple here. So first, when you reflect on the various differences between the studies specific to CTLA-4 and PD-1 combos, what are the really critical ones, in your view, that could lead to a different outcome from what we saw with MYSTIC today? Specifically, do you see this as issues of MYSTIC were about study powering and size? Or is there something specific with the agents and their dosing that led to this outcome? And if you're willing to comment on that.
My second question, anything from MYSTIC that would impact any of your thoughts around the 227 design, or more specifically, statistical powering (18:08) statistical plans?
And then finally, how are you thinking about PFS versus OS as a key endpoint as we think about the first-line lung market and I-O studies? Thanks very much.
Giovanni Caforio - Bristol-Myers Squibb Co.
Chris, this is Giovanni. Let me just start and then I'll ask Tom to give you any other comments. I think many of the – of course, it's very difficult to speculate on any comparison of the two studies because we don't know really a lot about the data that was communicated today.
With respect to the design of the study, first of all, as you mentioned, size is really important. Second, we should remember that the studies include two different medicines, both in terms of the PD-1 and PDL-1 and in terms of the CTLA-4. Dose and schedule are extremely important. And also, as we've said already, you have to remember that 227 really is a program and gives us the ability and optionality to look at multiple combination strategies in different patient populations.
But let me ask Tom to give you more comments about that.
Thomas J. Lynch, Jr., M.D. - Bristol-Myers Squibb Co.
Thank you, Giovanni. And, Chris, I think, again, it's important to reflect and think about these studies. There's much about MYSTIC that we don't know. All we've seen is the same press release that you saw this morning. But I think just to re-emphasize, first, the CTLA-4 drugs are different. They're different drugs. And dose and schedule may be important. We've spent a lot of time with Yervoy optimizing its dosing schedule across different tumor types. And we found that there are differences across that.
The second is the PD-1 target is different. We're a PD-1 drug, that's a PDL-1 drug. That could be when you combine with CTLA-4 potentially a difference between these trials. And you pointed out and Giovanni emphasized, the power and size are different between the two trials. So I think it's very difficult to read across the two studies.
You did ask a specific question about 227. And as you know, we have not disclosed our statistical plan for this study. And, again, I think that the data today certainly is one piece of the information, but I think that the ability to understand what the ultimate best way to treat patients will require more data from MYSTIC and certainly the results of both 227 and 9LA.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks, Chris. Hannah, can we go to the next question, please?
Operator
Yes. We'll go next to Vamil Divan with Credit Suisse.
Vamil K. Divan - Credit Suisse Securities (USA) LLC
Great. Thanks so much for taking the question. So I guess just a couple here. You mentioned the dose and schedule a couple times there in terms of differences here between 227 and MYSTIC. But I was also intrigued by the filing you had with the fixed dose, every four-week dose and you're relatively quiet in terms of talking about that with the Street before you submitted it. So just can you share a little bit more about the data you have around that new formulation and what gets you comfortable that this fixed dose will be appropriate across all tumor types?
Then maybe one, just shifting gear more to the results for the quarter. You raised the bottom end of your guidance range on EPS. Your sales guidance looks like it's essentially unchanged. Can you just share some thoughts on your views on the top line? And obviously, the moving parts in the back end of the year with the Keynote-189 study. What is it that's keeping you not changing sales guidance, even though you had a good quarter here and you are raising the bottom end of the EPS guidance? Thanks.
Giovanni Caforio - Bristol-Myers Squibb Co.
Thank you. So this is Giovanni. Thank you. I'll try to cover some of your points at a high level, and then I'll ask Charlie to make some comments on guidance and the rest of the year, and Tom and Murdo to give you some perspective on dosing. So first of all, let me say, our performance in the second quarter and actually in the first half of the year is very strong. Commercial execution continues to be very, very strong and trends are good across products and across geographies. So we see good momentum.
Obviously there is a degree of uncertainty in lung cancer, but here the U.S., similarly we are at the beginning of our launch of hepatitis C in China. So those are trends that are a little more difficult for us to comment. But, overall, I would say we feel we are in a really good position from a commercial execution perspective.
With respect to dosing, I think that, as Tom was mentioning, we are working really as a priority to continue to optimize the schedule of our assets across indications, across lines of therapy, in combination. And what you've seen with 227 is really a lot of work that went into the finding of that dose. Similarly, we've been working on the four weekly dosing for Opdivo monotherapy.
And I'll have just Charlie first, and then Tom and Murdo, give you more comments about that.
Charles A. Bancroft - Bristol-Myers Squibb Co.
Yeah, not much to add to what Giovanni said. We are pleased with the first half performance. There is uncertainty, as I mentioned in my comments, regarding Opdivo as we look at the second half of the year. And we're roughly two weeks into our hepatitis C opportunity in China.
Thomas J. Lynch, Jr., M.D. - Bristol-Myers Squibb Co.
So I think your question about our fixed-dose sBLA I think is a good one. And we think about how to use these drugs. We want to think about giving doctors and patients the most flexibility and optionality in the way they use these drugs for convenience and for potential efficacy when we combine them in different settings. So as you know, we have the 3mg per kg dose approved and the fixed dose at 240. So the ability to have a q4 week dose might be appealing for many patients and many doctors. And also to note, we also have in 227 the three-week fixed dose, so that can combine better with a Q3 week chemotherapy.
I think what patients and doctors want is the ability to use our drugs in a way that's most convenient for our patients and for physicians as we put together multiple combinations. I think as you're going to find, as combination therapy continues to play a greater role as we move forward, that this kind of flexibility in dosing will be very important as we move forward.
Murdo Gordon - Bristol-Myers Squibb Co.
Yeah. Vamil, the only thing I would add is, this could be particularly helpful in parts of the market where infusion infrastructure is a little more constrained. For example, academic medical centers, large regional hospitals. We have seen definitely some preference there for longer duration or longer interval between dosing. Whereas in the community setting, the q2 week dosing schedule we've had until now has been fairly well-accepted. So that q4 will have an advantage, definitely in the academic setting, definitely in the regional hospital setting. And then we are interested, as Tom mentioned, in pursuing the most convenient dosing across indications. And that may vary depending on combinations, as Tom mentioned, as we evolve our portfolio.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks, Vamil, for the question. Hannah, can we go to the next one, please?
Operator
Yes. We'll go next to Gregg Gilbert with Deutsche Bank.
Gregg Gilbert - Deutsche Bank Securities, Inc.
Thanks. First I was hoping, Tom, you could comment on your perspective of the PD-1 or PD-L1 agent hitting on OS after missing on PFS. Secondly, can you share your thoughts around the company's appetite to play in the PARP space? Pretty interesting collaboration announced earlier that could be material in the industry.
And lastly, you've begun to talk more about NASH this year. At this point, have you met with the FDA yet to plan a pivotal study and when could that start? Thanks.
Thomas J. Lynch, Jr., M.D. - Bristol-Myers Squibb Co.
Thanks, Gregg. And let's break these down into three parts. And I think I might start with the NASH first and then we'll talk about PD-1 and PARP. As you know, non-alcoholic steatohepatitis is an important clinical disease and it leads to cirrhosis. It leads to potential hepatocellular carcinoma down the road. We're very interested in our FGF21 agent. Because our FGF21 agent is able to approach all three elements that seem to be important in NASH and the pathophysiology of NASH. First, it approaches the metabolic derangement that we often see in NASH in terms of fat accumulation.
Second, it has the ability to reduce the inflammation that's important in the pathophysiology of NASH. And finally, it has anti-fibrotic impacts as well. And so we presented Phase II data on FGF21 at EASL this year that showed that we were able to reduce hepatic fat in a patient population of people with NASH, giving us a clear signal that this is something we wanted to take forward into Phase III.
And we have been discussing, to answer your question directly, we have been discussing our NASH data with regulatory authorities. And we hope to begin Phase III trials and a program by the end of this year, depending upon timing and how we're able to accomplish our timing. So this is an area that we definitely want to pursue. As we mentioned many times on these calls, we're not just a cancer company. Cardiology, fibrosis, immuno-science, are very important to Bristol-Myers Squibb.
The second question about PD-1 versus PDL-1. I think that's a terrific question. And if you go back two to three years, there were people who thought that PD-L1 drugs might turn out to be better than PD-1 drugs. And I think now, I think again, we have to really see where the data takes us and follow the science as we look at PD-1 drugs and PD-L1 drugs as we move forward.
And, again, around your question of overall survival versus progression-free survival in terms of endpoints, as an oncologist, we always like it when we see overall survival data. It certainly is something which can help doctors make decisions in terms of treating patients. But as we know, with the influence that second-line and third-line therapy has made, it's increasingly difficult to be able to demonstrate overall survival.
And so, for example, if you look at breast cancer. Many, many breast cancer drugs now have been approved on PFS. I do think that PFS and OS it will continue to be important endpoints and will be different in different studies as we move forward.
And finally, regarding PARP. I'll mention a couple comments from a scientific standpoint and turn it over to Charlie to offer more comments. I've always felt that PARP was an important target in oncology. DNA repair is clearly one of the hallmarks of tumor progression and it's something that mechanistically the ability to combine a PARP inhibitor with an I-O agent is something that, to me, is very appealing from a scientific standpoint.
And, Charlie, do you want to comment on...
Charles A. Bancroft - Bristol-Myers Squibb Co.
No, I would just say we think it's an interesting class and particularly it's synergistic with PD-1s and it looks like it may have applicability in tumors like ovarian and prostate and triple-negative breast. And it's something we continue to look at.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks, Gregg. Can we go to the next question, please, Hannah?
Operator
Yes. We'll go next to Tim Anderson with Bernstein.
Timothy Minton Anderson - Sanford C. Bernstein & Co. LLC
Thank you. A couple of questions. On 227, it's not terribly clear to me why you can't give some elements of statistical design. It's not like there's a wealth of CTLA-4 competitors that are going to suddenly go out and change their trials. So with that as my comment, I'm hoping you can at least talk about whether the analysis is going be hierarchical in nature, and maybe you can reveal what the starting cut point would be for that analysis.
And then on this first readout potentially by year-end, are you expecting that you'll have both PFS data and mature OS data at the same time? Or could the OSPs come a lot later, like it will in MYSTIC? The reason I ask that is that MYSTIC today shows us that maybe PFS is not a great measurement. So if your OS data isn't mature, I'm wondering if there's risk to this initial readout. Thank you.
Giovanni Caforio - Bristol-Myers Squibb Co.
Tim, this is Giovanni. First of all, I would say we've said all along that we have optionality with our statistical plan. We don't really see a need to make any change there. And with respect to the time lines for the study, the primary completion, as you said, is the first quarter of next year. We do have an opportunity for an interim on OS by the end of this year.
Charles A. Bancroft - Bristol-Myers Squibb Co.
And just to add, Tim, to your question. I think that we have not disclosed when the interim is. We've been saying all along that we expect to have some data in the first half of 2018. Whether that data will be PFS or OS, as Giovanni just mentioned, we have the optionality to look at both co-primary endpoints in the study, and we look forward to seeing the data.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks, Tim. Can we go to the next question, please, Hannah?
Operator
Yes. We'll go next to Umer Raffat with Evercore ISI.
Umer Raffat - Evercore Group LLC
Hi. Thanks so much for taking my question. I wanted to focus on (32:17) CTLA-4 combo, but outside of lung for a minute. So perhaps starting off in CheckMate -214, the renal trial. I was curious about the (32:25) dose selection every three weeks – every six weeks deployed in 227, and if there have been interims in that trial? And then also on CheckMate -651 in head and neck, are (32:35). Thank you.
Thomas J. Lynch, Jr., M.D. - Bristol-Myers Squibb Co.
So thanks for your question. Let me address the renal cell question as we think about it. So think about kidney cancer. Kidney cancer is an interesting disease. I can remember when I was training, the only drug that worked in kidney cancer was vinblastine and it really barely worked at all. And yet since then, we've seen the advent of tyrosine kinase inhibitors in kidney cancer and they've shown very good benefit, though not for all patients who get treated with the tyrosine kinase inhibitors.
And, clearly, there are patients with more severe adverse disease who don't necessarily seem to do as well with tyrosine kinase inhibitors, but they've made a huge difference in how we approach the disease. And then we've seen the advent of I-O and immuno-oncology agents and the difference they make.
As you likely know and are alluding to, we were delighted to be able to publish our study in the Journal of Clinical Oncology our Phase II trial looking at NIVO and IPI in patients with renal cell cancer. And as you know, the combination of NIVO plus IPI had a response rate at 40% with a two-year survival that was between 60% and 65% overall, which we think is very a encouraging data and is the basis for why we've proceeded with the randomized trial 214. Our hope is that we're going have some data from 214 by the end of this year as we move forward.
The second part of your question was about head and neck cancer. And, again, I want to emphasize, this has been a busy week for I-O in terms of readouts at various different head and neck trials. All we know from the pembro study is it did not meet its primary endpoint and we don't know much more than that in terms of details.
But what we do know and want to remind you of is that the nivolumab study in patients with head and neck cancer compared to investigator's choice chemotherapy did show a survival benefit, with a one-year survival rate of 36% versus 16% for the investigator's choice and has led to the use of single-agent nivolumab as we move forward. And as you mentioned, we do have additional data that we plan to present in head and neck cancer next year.
So CheckMate -651, as you mentioned, is a trial looking at IPI-NIVO versus chemotherapy and cetuximab in patients with head and neck cancer. And we expect to have that data the first half of 2018. And we also have a trial that will be maturing in the first half of next year looking at the combination of IPI-NIVO versus NIVO in patients who aren't able to tolerate cisplatin and cetuximab.
As you know well, head and neck cancer patients are a uniquely comorbid group of patients with lots and lots of comorbidities that make aggressive treatments challenging. And so we are very happy that we have trials that cover the broad range of how patients present with head and neck cancer and what doctors see with head and neck cancer.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks, Umer. Hannah, can we go to the next question, please?
Operator
We'll go next to Seamus Fernandez with Leerink.
Seamus Fernandez - Leerink Partners LLC
Great. Thanks for the question. So just two questions. First, Tom, can you remind us again your biomarker strategy and how you see this impacting lung? I'm particularly interested in the application of the tumor mutation burden test as a stratifying metric in the new lung study that you guys just announced for the combination.
And then the second question is just, can you give us just a general sense of how excited you are and perhaps when we might see data from either the LAG-3 or the Flexus IDO in tumors outside of melanoma? And if you are willing to expand a little bit, do you have plans for registrational trial starts in tumors outside of melanoma for either of those two assets? Thanks.
Thomas J. Lynch, Jr., M.D. - Bristol-Myers Squibb Co.
Okay. So let's get to the meat of the question. So first question, Seamus, that you asked us about, our biomarker strategy. And this is an area of great interest to me and it's an area of great importance to patients across the spectrum. And so if you think about lung cancer, and we've said many times it's a difficult disease to treat. But I think the thing that I've been very impressed with in lung cancer as a lung cancer clinician is how this disease has evolved and how it's fragmented over the past 10 years.
If you go back 10 years, 10 years ago we just thought of small cell and non-small cell and that's what you used to make your treatment decisions. Now when a doctor is looking at a patient with lung cancer, they're thinking about EGFR. They're thinking about ALT. They're thinking about ROS1. They're thinking about PD-L1 expression. And I think that they may soon be thinking about TMB as an important marker as well in cancer.
And so let's think, what is TMB? TMB is tumor mutation burden. It's a measure of the amount of mutations that are present in protein coding genes in patients' samples. And when you think about it, some people think it's important in and of itself. Others think that TMB is really a reflection of important tumor neoantigens and that one day we might be able to look at the TMB data and define which tumor neoantigens are actually driving the immune response.
So we've been happy that we've been able to look back and use TMB in a number of settings. As you know, the data we presented at AACR, we're able to look at TMB in patients in our 026 study and we were able to identify a group of patients who did very well with monotherapy. And we will continue to look at TMB in a number of different tumor settings when the data allows and when we're able to do it.
And I think one of the examples and an example of the commitment we have to TMB is in our study 9LA which is now available on ClinicalTrials.gov. We actually will be prospectively collecting TMB as part of the 9LA study, which is our trial of standard chemotherapy versus two cycles of chemotherapy with Opdivo and Yervoy. And, again, we have to follow the data. The data we have so far is early, but it certainly gives us reason to think that this could turn out to be something important in patients with cancer.
Your second question comes down to IDO and where we stand with IDO. And as you know, this is also something very important to Bristol-Myers Squibb. We thought enough of IDO as a target that we went ahead and purchased the IDO asset from Flexus, which is now the Bristol-Myers IDO. And we have announced that we will be moving forward with trials with the Bristol-Myers IDO as we go forward.
We think that there are some things about our IDO which could actually be differentiating and might prove to be important. We think we see excellent receptor occupancy. We think we see very good suppression of kynurenine levels, suggesting that we're inhibiting the enzyme. And this may allow Opdivo to be a more effective immuno-stimulatory agent. So we're excited about where the Bristol IDO can go in its combination with nivolumab.
But in addition to this, we also have a relationship with Incyte and you saw in ASCO this year the first data with the Incyte IDO along with Opdivo and we saw very strong response rates in melanoma and in head and neck cancer. And so, again, eagerly awaiting to see how we get these trials going. As we have announced, we plan to start our trials with Incyte by the end of this year and we hope to also have our Bristol-Myers trials up and running as well during that timeframe.
And finally with LAG-3. LAG-3 is something I was extremely excited about at ASCO. And why was that important? I think you learn a lot by studying resistance. And if you look at the most importance thing about LAG-3 so far is that we looked at patients who had prior treatment with immuno-oncology agents with melanoma and we were able to find a percentage of patients that responded to LAG-3 plus Opdivo in that setting.
And more importantly, we were able to use the biomarker of LAG-3 positivity to select a group of patients that had almost a 3 times higher response rate in that setting. So we think LAG-3 is an important target and we're going to continue to develop the biomarker, the LAG-3 biomarker, and we're going to continue to look at LAG-3 in IO-naïve patients with melanoma as well as expanding our experience in previously treated patients.
Giovanni Caforio - Bristol-Myers Squibb Co.
Seamus, maybe if I can add a couple of comments there. I think these developments that Tom articulated for you are really important for us because we've discussed this before. And when you think about our strategic priority, advancing that early pipeline, in oncology and outside of oncology is clearly a very important priority for us. So I'm personally very pleased that we are working between now and the end of the year to start a number of registrational programs.
We mentioned FGF21 outside of oncology. Tom mentioned LAG-3, the two IDO programs and nivolumab is another important program. I'm very pleased we are seeing the beginning of a number of registrational programs that are going be really important for us as a company. And even more broadly, I think what we've discussed today is how we are advancing a very broad program in lung cancer which continues to expand and advance.
The second pillar is how we are moving forward with a broad number of short-term opportunities for Opdivo and Yervoy within oncology beyond lung cancer. And the third pillar is really the new pipeline. And I think you are seeing that we're making very, very good progress across every one of those three areas.
John E. Elicker - Bristol-Myers Squibb Co.
Thank you, Seamus. Hannah, can we go to the next question, please?
Operator
We'll go next to Andrew Baum of Citi.
Andrew S. Baum - Citigroup Global Markets Ltd.
Hi. Three questions, please. The first one relates to MYSTIC. So your competitors seemed to highlight that a number of trials with I-O have missed PFS and gone on to hit overall survival, and head and neck is obviously one of them for you. You obviously have more experience with I-O than anyone else in this space.
Our concerns is the examples of missed PFS that hit OS with I-O all seem to be in trials with short PFS, where patients have been through multiple lines of therapy, which looks to us very different from the situation with first-line non-small cell lung. With that in mind, if you were facing a similar situation with 227, which I hope you won't, where you've missed PFS with the Opdivo Yervoy combination, how confident would you be feeling about making the OS? That's the first question.
Second, just going back to the differences between the individual molecules. To what extent is your development plan for non-fucosylated CTLA-4 reflect the fact that you believe effector function is a critical element of the efficacy of the molecule different from your competitor?
And then finally, just on patient selection, aside from baseline tumor load, to what extent do you think their learnings in optimizing the patient population using baseline tumor load, performance data, liver mets, which may significantly skew any data you may get from a large clinical trial, and to what extent can that be leveraged in your recruitment criteria? Thank you.
Thomas J. Lynch, Jr., M.D. - Bristol-Myers Squibb Co.
Andrew, thank you for your questions. And the first question is really a hypothetical. And it really is impossible for me to be able to opine on a potential hypothetical of missing PFS or hitting PFS or missing OS or hitting OS. And I really think we have to wait until we get more data from the MYSTIC study to really understand that. As we've said earlier, we have PFS and OS as co-primary endpoints in 227 and we have not disclosed our final statistical plan in that setting.
Your second question regards the new formulation of the non-fucosylated CTLA-4. I think one of the reasons we've looked at these two new CTLA-4 targets, first, we believe in the target. We think the target's important. The target's been shown to have a survival advantage, and as I illustrated in my answer to Jami's question. So we think the target's important. And if we think the target's important. And if we think the target's important, the question then becomes, how do we optimize the therapeutic index? How do we make CTLA-4 a better molecule, an even better molecule than it is? And there's two main approaches.
With the CytomX approach, the thought is, the Probody technology will allow a differential exposure of tumors to CTLA-4, allowing us to enhance the immune response within the tumor itself and possibly not see the same degree of side effect profile that you could see with immune side effects in other areas. So that's the thought behind the new formula, behind the CytomX approach.
With the new formulation, there's a possibility that there could increased potency of the drug that could actually allow us to have more effectiveness in that setting. And, again, very early. We just started, as we announced at the last earnings call, we just started trials with the non- fucosylated CTLA-4. And so we're going have to see how that evolves.
And your third question, Andrew, is around the concept of patient selection. And I think you've hit a very important point is that, as we look at these cancer types, and as I mentioned this about lung cancer earlier, we are seeing increased fragmentation in the patient populations. And we're seeing the biomarker selection is becoming increasingly important as we look at patient populations.
Lung cancer, for example, is not just one disease. It's many diseases defined by EGFR and ALK and ROS and possibly Tumor Mutational Burden and PD-L1 positivity. So I think as we go forward, attention to patient selection and attention to thinking are we treating the right patients is something that we take very seriously in our tumor design and our trial design. It's one of the reasons, as Charlie mentioned earlier, we're continuing to up-invest in R&D and up-invest in translational medicine because we think it's important for us to prospectively be selecting the correct patients.
John E. Elicker - Bristol-Myers Squibb Co.
Thank you, Andrew. Hannah, can we go to the next question, please?
Operator
We'll go next to Steve Scala with Cowen.
Steve Scala - Cowen & Co. LLC
Thank you. I have a couple questions. On CheckMate 227, is the interim in 2017 on PFS or OS? I think Giovanni said OS. I had thought it was also PFS or only PFS, so please clarify. And related to that, why would it make sense to do the interim look in Q4 as opposed to Q3 since the conclusion is in January? Would you agree Q4 doesn't provide much benefit in terms of the timing? So that's the first question.
The second question is regarding CheckMate 568. I think Bristol is saying there is a possible update in 2017. What does whether there is an update or not depend on? Thank you.
John E. Elicker - Bristol-Myers Squibb Co.
Hey, Steve. It's John. Real quick on their interim analysis. We have said all along that, like in all of our trials, we've built in optionality, which we have in 227. In terms of timing, everything is event-driven. So we've never committed to January, even though that may be what's on ClinicalTrials.gov. And we've said sometime in the first part of 2018 is when the primary endpoint should read out. So both the interim and the primary analysis are event-driven, and so, obviously, time flexible.
Thomas J. Lynch, Jr., M.D. - Bristol-Myers Squibb Co.
So, Steve, regarding your question on 568, I'll just give you a little bit of color behind 568 and how it got to the place where it is. 568 was designed as practice-enabling study of Opdivo and Yervoy. We initially designed 568 to be about 160, 170-patient study initially. And with more experience, we decided to increase that size to 300 patients. And then last year we decided to actually add a randomized portion to 568 looking at this question of two cycles of chemotherapy followed by Opdivo and Yervoy, and that will be an all-comers trial.
Now, after discussions with the Agency, we've actually decided to make that a separate Phase III trial. So that's the trial that's now called 9LA. And so that trial will get going. We hope the first patients will enter that trial. We have a safety lead-in right now, which, to the best of our ability, seems to be going well with the two cycles followed by Opdivo Yervoy. And so we hope to begin accrual for that trial in September of this year if all goes according to plan.
As of now, we have not yet decided upon our presentation strategy for 568, but we look forward to sharing that with you when we have.
John E. Elicker - Bristol-Myers Squibb Co.
Thank you, Steve. Hannah, can we go to the next question, please?
Operator
We'll go next to David Risinger with Morgan Stanley.
David R. Risinger - Morgan Stanley & Co. LLC
Thanks so much. I have three questions. The first is, with respect to U.S. Opdivo in the second quarter, could you just provide the percentage of sales in different cancer types in the second quarter?
Second, with respect to your expectation for Yervoy combo Phase III kidney cancer results by the end of the year, could you just help reconcile that with ClinicalTrials.gov? ClinicalTrials.gov indicates a primary completion for that trial on September 30 of 2019. So it makes me wonder why look at any Bristol-Myers dates on ClinicalTrials.gov.
And then finally, with respect to your Flexus IDO, when do you expect to present Phase I data on that later this year? Thank you.
Giovanni Caforio - Bristol-Myers Squibb Co.
Okay. David, let me ask Murdo to start and give you some data on Q2 U.S.
Murdo Gordon - Bristol-Myers Squibb Co.
David, for Q2 U.S. about 50% to 55% of our sales are in non-small cell lung cancer for Opdivo. And renal cell carcinoma is between 15% and 20%. And then the other big one for us is melanoma, at 10% to 15%. There are obviously other tumors, with bladder, head and neck and others, but those are the three big ones and that's the split.
Giovanni Caforio - Bristol-Myers Squibb Co.
For the 214, by the end of this year that is an interim analysis. You may be referring to the final analysis. And let me ask Tom to give you an answer to your question, to your third question.
Thomas J. Lynch, Jr., M.D. - Bristol-Myers Squibb Co.
And your third question regarding the Flexus IDO, we hope to have data, in fact, we're pretty sure we will have data, for the CITIM Meeting this fall.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks, Dave. Can we go to the next one, please, Hannah?
Operator
Yes. We'll go next to Geoff Meacham with Barclays.
John E. Elicker - Bristol-Myers Squibb Co.
Geoff, are you there?
Geoff Meacham - Barclays Capital, Inc.
Yes, I am. Can you hear me?
John E. Elicker - Bristol-Myers Squibb Co.
Now we can, yes.
Geoff Meacham - Barclays Capital, Inc.
Okay. So thanks for the questions. So, Tom, another one on CTLA-4. Obviously data-dependent. But if 227 looks underwhelming, would a strategy be to explore triple combos in lung? I'm just thinking with all the assets and novel mechanisms you guys have in-house, whether you view CTLA-4 as more foundational.
And then for Murdo on the quarter, can you give us some perspective on second-line lung share new start trends? Just trying to think whether KEYTRUDA is slowing starts. And then looking forward, would you expect any formal reimbursement limitations on sequential I-O therapies in lung? Thank you.
Giovanni Caforio - Bristol-Myers Squibb Co.
Geoff, why don't we start with Murdo to give you some perspective on your more commercial questions. And then Tom will address your CTLA-4 question.
Murdo Gordon - Bristol-Myers Squibb Co.
Okay. Thanks, Geoff. In second-line lung cancer our shares have actually been very stable. So we run around 40% share of second-line lung cancer. And that market volume has held up quite well so far because the impact of pembro usage in first-line has not yet been felt in a reduction of eligible second-line patients.
That will change as we get closer to the end of the year where the shares in second-line lung should hold, but the addressable eligible population of second-line I-O naïve patients will start to shrink. And obviously next year, there will be a smaller pool as well.
I will say, our teams have done extremely well in establishing this holding of share despite two competitors in the second-line setting. And ex-U.S., we've done very well given the lead that we've got in second-line in many markets due to fast reimbursement. So the emergence of our lung cancer business ex-U.S. is also driving some nice growth.
And then outside of lung cancer, our shares are very good in regimen in melanoma, in head and neck we've seen some recent acceleration. In renal cell, we've held up well. Bladder, we're emerging. Actually the broad usage in other areas where NCCN is updated, like Tom mentioned in mesothelioma, is also helping to drive growth outside of lung. So we feel good about that.
In terms of reimbursement limitations, really in the U.S., we have seen very good prior authorization approvals in the mid to high-90% range even in combination settings. And, of course, in melanoma it's really the market where we see the most in combination used today. Now, we are obviously tracking the U.S. environment very closely. And we are, I think, in a very good competitive position should there be further restriction or barriers to combination reimbursement as you see sequential lines of therapy evolve, given that we have multiple targets and multiple combinations to use in those settings.
Giovanni Caforio - Bristol-Myers Squibb Co.
Tom?
Thomas J. Lynch, Jr., M.D. - Bristol-Myers Squibb Co.
So Geoff, thank you for your question. And this is an area of great interest to me. So the first thing is, I can't really think about hypothetical of 227 and MYSTIC. So I think it's really not helpful to think about hypotheticals.
But I do think it's important to think about triples. And something I've been interested in for quite some time is this idea that I really think that to begin to think about how we're going to be driving prolonged survivals in cancers, we've really only begun to scratch the surface in terms of thinking how to use these drugs.
And I do think that triple therapy, quadruple therapy, down the road makes sense. Just think about lymphoma. And you think about the fact that we can cure lymphoma now with five drugs. We've made a huge difference for patients with lymphoma in that setting. And it's entirely possible that ultimately the way we approach lung cancer, other cold tumors and even melanoma will be with multiple drugs.
So for example, we have announced that we have begun some dose-finding studies in early trials with IDO inhibitor plus Opdivo and Yervoy, looking at that together to try to learn, could there be a signal with that triplet in melanoma. And we also have plans to look at a LAG-3 with IDO and Opdivo as well.
And so we are committed to multiple drug combinations. Of course, the difficult thing is as you begin to put together multiple drug combinations, trying to determine the relative impact of the different components becomes very challenging and requires a tremendous amount of creativity and innovation in clinical trial design.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks, Geoff. Hannah, I think we have time for two more questions.
Operator
Thanks. We'll go next to Marc Goodman with UBS.
Marc Goodman - UBS Securities LLC
Good morning. So first, Murdo, for Opdivo, can you give us a sense of where the OUS sales are coming from, just like you did with the U.S.?
Second, on Eliquis, where is the market share now for the cardiologist specialist? Just give us a sense there?
And then third, for Daklinza, can you confirm there were no sales in the second quarter for China, and can you give us a sense of what kind of ramp should we be expecting in China? Obviously, hep C we've seen pretty amazing ramps when these products launched. So give us a sense of how we should expect sales for China. Thanks.
Murdo Gordon - Bristol-Myers Squibb Co.
Sure. Thanks, Marc. Ex-U.S. we've seen very nice launch progression in Japan, France, Germany, Italy, Spain. We are very early in our launch trajectories in Canada. We're hopeful that we'll be launching soon in Australia. In the U.K., we've launched in our regimen setting in melanoma, and it's going extremely well. So our business is really broad, and we've got over 20 markets ex-U.S. now reimbursed either fully in lung, renal and melanoma, or at least lung and melanoma. And we're working now on our head and neck and bladder indications to be able to secure reimbursement there.
So I think our position in Europe, in particular, is very, very strong because of the timing advantage we've secured with indications there and with the rapid uptake that we've been able to achieve. So OUS I feel very good about, and the teams have done extremely well across medical and commercial to launch.
With respect to Eliquis, we are sitting with very strong shares now. We are at roughly 53% Eliquis TRx share. And we're leading – and we've got large shares in NBRx leading that just a few more points. So we're growing very well in Eliquis. And, of course, there's still a lot of warfarin used in total prescriptions in the U.S., with about 47% of the market still in warfarin. And in NBRx, that's down now to roughly 30%. 29%, if I remember. So we still see a lot of headroom for growth on Eliquis, but very, very good share trends there. And leading in our categories in BTE and atrial fibrillation.
And with respect to Daklinza in China, we did not book any sales in the second quarter. We have started to book sales this quarter. The uptake curve in China with the dual of Daklinza and Sunvepra is a very difficult thing to predict. We are in the process of securing some reimbursement now in three main provinces in China. We are currently selling primarily in the private pay sector. So more to report on that next quarter. But obviously we're very excited about the opportunity being first in the market and being able to help a very large unmet need and a very large patient population in China.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks, Marc. And, Hannah, can we go to our last question, please?
Operator
We'll go to Tony Butler with Guggenheim.
Tony Butler - Guggenheim Securities LLC
Yes, thanks very much. Two questions, Tom, for you. One, if I may go back to FGF21 and NASH and Phase III. And the question is, could you share the designed, if there is a clinical endpoint, for the Phase III program? Or is it simply looking at tissue histology following sort of end of trial biopsy? That's one.
And then second, back to MYSTIC and 227. Is there – I understand dose and schedule and a lot of the comments that you've made. But are there perhaps other characteristics of these antibodies that may be substantially different which could actually allow for some clinical differentiation?
For example, one being IgG1 versus IgG2. Don't know if that really matters, but it could.
Clearly, you've made some comments that glycosylation could affect binding characteristics for ipilimumab. I'm just looking for something more than simply dose and scheduling, if you think that might be useful. Appreciate the time.
Thomas J. Lynch, Jr., M.D. - Bristol-Myers Squibb Co.
Tony, thank you for your question. The first on FGF21 is the data on the design of those trials will be available on ClinicalTrials.gov. It's something we're discussing with the regulatory agencies now.
The second question is a good one. And many people have suggested that IgG1 versus IgG2 could explain potential differences. They are different drugs, so there does exist a possibility that there could be differences. But, again, our job is trying to define the best way to use CTLA-4 based Yervoy and our agents. And really I don't have a real thought as to how important these other factors could be. I mean, there's certainly some science that suggests that there could be some differences. But, again, it's again very early in the process of understanding how they work.
Giovanni Caforio - Bristol-Myers Squibb Co.
Thank you, Tom. Thanks, Tony. Again, we just completed another strong quarter. I am very pleased with execution across the company. As you've seen, we've delivered strong sales performance and we are continuing to make good progress from a clinical perspective and from a regulatory perspective.
Looking ahead, as I said at beginning, I see tremendous opportunity for us to continue to grow and I am very confident that we're well-positioned for the long term. So thanks, everyone, and have a good day.
Operator
And this concludes today's conference. Thank you for your participation. You may now disconnect.
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https://seekingalpha.com/article/4091586-bristol-myers-squibb-bmy-q2-2017-results-earnings-call-transcript?part=single
BMY
Cancer drug war heats up as Big Pharma squares off against Genentech
Jul 26, 2017, 2:48pm PDT Updated Jul 26, 2017, 6:23pm PDT
Ron Leuty
Reporter
San Francisco Business Times
Drug giant Bristol-Myers Squibb Co. filed suit Wednesday against biotech pioneer Genentech Inc., saying the South San Francisco company infringed patents in developing a potential blockbuster cancer immunotherapy drug.
Bristol-Myers Squibb (NYSE: BMY) seeks unspecified damages in the suit, filed in U.S. District Court in Delaware. At stake are sales of potentially billions of dollars worth of cancer drugs.
The suit centers around the white-hot area of cancer immunotherapy, where cancer patients' own immune systems are tweaked to ramp up their ability to fight tumors. Those therapies have seen response rates of 20 percent or greater in the short term, but researchers have keyed in potential combination therapies to accelerate those rates and extend the time cancers are held back.
Trending: Here's how much early-career salaries can differ at San Francisco tech companies
In its suit, BMS says Genentech's cancer fighting drug Tecentriq, or atezolizumab, is "exploiting" patents for the New York-based company's Opdivo, or nivolumab.
Both drugs are used to amp up the immune response: Opdivo, initially approved in 2014 as a treatment for skin cancer, is what's called a PD-1 checkpoint inhibitor, removing the brakes that tumors put on the immune system; PD-L1, a protein Tecentriq targets, is manufactured by cancer cells to cloak themselves from the immune system.
PD-L1 binds to the PD-1 checkpoint, so it is believed to be a way to block that cancer pathway.
Opdivo also has been approved for types of lung and kidney cancers.
Genentech, the U.S. biotech subsidiary of Swiss drug giant Roche, won approval last year of Tecentriq's use in bladder cancer. It also is used to treat non-small cell lung cancer.
BMS has separate suits against AstraZeneca plc (NYSE: AZN) and Pfizer Inc. (NYSE: PFE)/EMD Serono/Merck KGa.
"The purpose of these lawsuits is to seek compensation for the infringement of our intellectual property rights and to protect our immuno-oncology business," BMS spokeswoman Lisa McCormick Lavery said in a statement Wednesday. "In these lawsuits, Bristol-Myers Squibb and our partner, Ono Pharmaceutical, assert that the sale of anti-PD-L1 antibodies in the U.S. will infringe our patents pertaining to the use of anti-PD-L1 antibodies to treat tumors.
"These lawsuits do not seek to interfere with patient access to these products," Lavery said in the emailed statement.
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https://www.bizjournals.com/sanfrancisco/news/2017/07/26/genentech-cancer-immunotherapy-bms-bmy-pd-1-pd-l1.html
BMY
Seeking Alpha should have a transcription of the call later today which I will post.
BMY
This seems to be the story, not the financials which generally were positive:
_______________________________________________________________
AstraZeneca shares plummet 16% on late-stage trial failure; Bristol-Myers shares fall 6% and Merck shares rise 5%
Published: July 27, 2017 8:07 a.m. ET
AstraZeneca PLC AZN, -15.35% shares plummeted as much as 16% in premarket trade Thursday after the company said its cancer drug combination failed to meet its primary endpoint in a late-stage clinical trial. In the AstraZeneca late-stage trial, the combination of the drugs Imfinzi and tremelimumab -- intended for previously-untreated patients with metastatic first-line non-small cell lung cancer -- did not improve progression-free survival compared to the standard of care. The results could have implications for Bristol-Myers Squibb Co.'s BMY, -5.06% cancer drug combination, and the company's shares dropped 6.2% in premarket trade. Meanwhile, shares of cancer drug rival Merck & Co. MRK, +5.08% -- which has a key position in the first-line lung cancer market with cancer drug Keytruda -- rose 5% in premarket trade. For AstraZeneca, "this is a clear disappointment given the large market opportunity," said Leerink Research analyst Seamus Fernandez. "The read-through is an obvious negative read-through for BMY's combo of Opdivo and Yervoy in the ongoing CheckMate-227 trial... While there are several key differences in trial design between MYSTIC and CM-227, they are unlikely to result in meaningfully different outcomes." However, EvercoreISI analyst Umer Raffat was slightly more optimistic, noting that the AstraZeneca trial isn't over yet and also has overall survival as a primary endpoint, with results expected in the first half of next year. "It will be unreasonable to pretend as if nothing has changed on MYSTIC... but I also acknowledge that we shouldn't forget about several [immuno-oncology] trials which have delivered [overall survival] benefit despite not having any [progression-free survival] benefit," Raffat said. AstraZeneca shares have surged 10% over the last three months, Bristol-Myers shares have lifted 0.6% and Merck shares have dropped 1.3%, compared with a 3.7% rise in the S&P 500 SPX, +0.03%
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http://www.marketwatch.com/story/astrazeneca-shares-plummet-16-on-late-stage-trial-failure-bristol-myers-shares-fall-6-and-merck-shares-rise-5-2017-07-27
BMY
In INO @ $5.90 (didn't get complete fill). New to this company, looking for a bump up when offering is complete.
INO
In NEOS for the 1st time @ $6.50. May be early for catalyst, but price seems right.
NEOS
Bristol-Myers Squibb’s ORENCIA® (abatacept) Receives Second European Commission Approval in Less than a Year – New Approval for Treatment of Active Psoriatic Arthritis (PsA)1
JUL 26, 2017
Patients demonstrated improved disease response in two clinical trials that included both TNF-naïve and challenging to treat TNF-exposed patients with active musculoskeletal involvement1
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE: BMY) announced today that the European Commission (EC) has approved ORENCIA alone or in combination with methotrexate for the treatment of active Psoriatic Arthritis (PsA) in adult patients for whom the response to previous disease-modifying antirheumatic drug (DMARD) therapy, including methotrexate, has been inadequate, and additional systemic therapy for psoriatic skin lesions is not required.1
This approval, which allows for the expanded marketing of ORENCIA as a treatment for PsA in all 28 Member States of the EU, marks the second new indication for ORENCIA in less than a year; in September 2016, the European Commission approved ORENCIA, in combination with methotrexate (MTX), for the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis (RA) not previously treated with MTX. PsA becomes the third autoimmune condition, along with rheumatoid arthritis and juvenile idiopathic arthritis, for which ORENCIA is approved to treat in Europe.1
“This EC approval builds on the well-established profile of ORENCIA in Rheumatoid Arthritis and exemplifies our commitment to ongoing clinical research of ORENCIA as a potential treatment for autoimmune conditions where treatment options are limited or where patients have not been helped enough by other medications,” said Brian J. Gavin, Ph.D., Vice President, ORENCIA Development Lead at Bristol-Myers Squibb. “Despite the current availability of medications, there are many people with active Psoriatic Arthritis who are in need of a new treatment option; the approval of ORENCIA now provides a novel immunotherapy approach that may help these patients.”
The approval was based on results from two randomized, double-blind, placebo-controlled studies (Studies PSA-I and PSA-II) in which a higher proportion of patients achieved an ACR 20 response, the primary endpoint, after treatment with ORENCIA 10 mg/kg intravenous (IV) or 125 mg subcutaneous injection (SC) compared to placebo at Week 24: 47.5% versus 19.0% and 39.4% versus 22.3% (p< 0.05), respectively.1 Responses were seen regardless of prior tumor necrosis factor inhibitor (TNFi) treatment in both studies.1
In the phase 3 study, PsA-II, the proportion of radiographic non-progressors (≤0 change from baseline) in total PsA-modified SHS on x-rays at Week 24 was greater with ORENCIA 125 mg SC (42.7%) than placebo (32.7% (10.0 [1.0, 19.1] estimate of difference [95% CI]).1 There were no adverse reactions that occurred at ≥ 2% in either treatment group during the 24-week placebo-controlled period. The overall safety profile was comparable between studies PsA-I and PsA-II and consistent with the safety profile in rheumatoid arthritis.1 Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events occurring at a rate of ≥ 10% in patients taking ORENCIA in the adult RA clinical studies.1
In PsA, the immune system attacks healthy joints and skin.3 T-cell activation is involved in the pathogenesis of PsA.4 The costimulation blockade of ORENCIA inhibits T-cell activation and the resulting cascade of events that contribute to joint destruction. Both IV and SC injection formulations of ORENCIA are now approved to treat adult patients with active PsA.
Additional Information About Studies PSA-I and PSA-II
The efficacy of ORENCIA was assessed in two randomized, double-blind, placebo-controlled studies (Studies PsA-I and PsA-II) in 594 adult patients,1 with a disease duration more than 7 years.4,5 Patients had active PsA (≥ 3 swollen joints and ≥ 3 tender joints) despite prior treatment with DMARD therapy and had one qualifying psoriatic skin lesion of at least 2 cm in diameter.1 In PsA-I and PsA-II, 37% and 61% of patients, respectively, were treated with TNFi previously.1 The primary endpoint for both PsA-I and PsA-II was the proportion of patients achieving ACR 20 response at Week 24 (Day 169).1
In PsA-I, 170 patients received placebo or ORENCIA IV at Days 1, 15, 29, and then every 28 days thereafter in a double blind manner for 24 weeks, followed by open-label ORENCIA 10 mg/kg IV every 28 days.1 Patients were randomized to receive placebo or ORENCIA 3 mg/kg, 10 mg/kg (weight range-based dosing: 500 mg for patients weighing less than 60 kg, 750 mg for patients weighing 60 to 100 kg, and 1000 mg for patients weighing greater than 100 kg), or two doses of 30 mg/kg followed by weight range-based dosing of 10 mg/kg without escape for 24 weeks, followed by open label ORENCIA 10 mg/kg monthly IV every month.1 Patients were allowed to receive stable doses of concomitant methotrexate, low dose corticosteroids (equivalent to ≤ 10 mg of prednisone) and/or NSAIDs during the trial. At enrollment, approximately 60% of patients were receiving methotrexate.1
In PsA-II, also known as ASTRAEA, 424 patients were randomized 1:1 to receive weekly doses of SC placebo or ORENCIA 125 mg without a loading dose for 24 weeks, followed by open-label ORENCIA 125 mg SC weekly.1 Patients were allowed to receive stable doses of concomitant methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, low dose corticosteroids (equivalent to ≤ 10 mg of prednisone) and/or NSAIDs during the trial. At randomization, 60.4% of patients were receiving methotrexate.1
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic6, inflammatory disease that can affect both the skin and musculoskeletal system.2 PsA can cause joint pain, stiffness and reduced range of motion, and can eventually lead to irreparable joint damage.2 Most commonly affecting the distal joints (those closest to the nail) of the fingers or toes, as well as the wrists, knees, ankles and lower back, the disease usually appears between the ages of 30 to 50, but can begin as early as childhood.2 Men and women are equally at risk.2 Early recognition, diagnosis and treatment of Psoriatic Arthritis are critical to relieve pain and inflammation and help prevent joint damage.2
U.S. Indications/Usage and Important Safety Information for ORENCIA® (abatacept)
Indication and Usage
Adult Rheumatoid Arthritis (RA): ORENCIA® (abatacept) is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. ORENCIA may be used as monotherapy or concomitantly with disease-modifying, anti-rheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists.
Juvenile Idiopathic Arthritis (JIA): ORENCIA® (abatacept) is indicated for reducing signs and symptoms in patients 2 years of age and older with moderately to severely active polyarticular JIA. ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX).
Adult Psoriatic Arthritis (PsA): ORENCIA® (abatacept) is indicated for the treatment of adult patients with active PsA.
Important Limitations of Use: ORENCIA should not be administered concomitantly with TNF antagonists, and is not recommended for use concomitantly with other biologic RA therapy, such as anakinra.
Important Safety Information for ORENCIA® (abatacept)
Concomitant Use with TNF Antagonists: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult RA patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63%) and serious infections (4.4%) compared to patients treated with only TNF antagonists (43% and 0.8%, respectively), without an important enhancement of efficacy.
Hypersensitivity: Anaphylaxis or anaphylactoid reactions can occur during or after an infusion and can be life-threatening. There were 2 cases (<0.1%; n=2688) of anaphylaxis or anaphylactoid reactions in clinical trials with adult RA patients treated with intravenous ORENCIA. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in <0.9% of patients. There was one case of a hypersensitivity reaction with ORENCIA in JIA clinical trials (0.5%; n=190). In postmarketing experience, a case of fatal anaphylaxis following the first infusion of ORENCIA was reported. Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use. If an anaphylactic or other serious allergic reaction occurs, administration of ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.
Infections: Serious infections, including sepsis and pneumonia, have been reported in patients receiving ORENCIA. Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which, in addition to their underlying disease, could further predispose them to infection. Caution should be exercised in patients with a history of infection or underlying conditions which may predispose them to infections. Treatment with ORENCIA should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis and viral hepatitis in accordance with published guidelines, and if positive, treated according to standard medical practice prior to therapy with ORENCIA.
Immunizations: Live vaccines should not be given concurrently with ORENCIA or within 3 months of its discontinuation. The efficacy of vaccination in patients receiving ORENCIA is not known. ORENCIA may blunt the effectiveness of some immunizations. It is recommended that JIA patients be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating therapy with ORENCIA.
Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): Adult COPD patients treated with ORENCIA developed adverse events more frequently than those treated with placebo, including COPD exacerbations, cough, rhonchi, and dyspnea. In adult RA studies, 97% of COPD patients treated with ORENCIA developed adverse reactions versus 88% treated with placebo and respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43% vs 24%, respectively), including COPD exacerbation, cough, rhonchi, and dyspnea. A greater percentage of adult RA patients treated with ORENCIA developed a serious adverse event compared to those on placebo (27% vs 6%), including COPD exacerbation [3 of 37 patients (8%)] and pneumonia [1 of 37 patients (3%)]. Use of ORENCIA in patients with RA and COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.
Blood Glucose Testing: ORENCIA for intravenous administration contains maltose, which may result in falsely elevated blood glucose readings on the day of infusion when using blood glucose monitors with test strips utilizing glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ). Consider using monitors and advising patients to use monitors that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase or glucose hexokinase test methods. ORENCIA for subcutaneous (SC) administration does not contain maltose; therefore, patients do not need to alter their glucose monitoring.
Pregnancy: There are no adequate and well-controlled studies of ORENCIA use in pregnant women and the data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. A pregnancy registry has been established to monitor pregnancy outcomes in women exposed to ORENCIA during pregnancy. Healthcare professionals are encouraged to register patients by calling 1-877-311-8972.
Lactation: There is no information regarding the presence of abatacept in human milk, the effects on the breastfed infant, or the effects on milk production. However, abatacept was present in the milk of lactating rats dosed with abatacept.
Most Serious Adverse Reactions: Serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo).
Malignancies: The overall frequency of malignancies was similar between adult RA patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in RA patients treated with ORENCIA (0.2%) than those on placebo (0%). A higher rate of lymphoma was seen compared to the general population; however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of ORENCIA in the development of malignancies in humans is unknown.
Most Frequent Adverse Events (≥10%): Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events in the adult RA clinical studies. Other events reported in ≥5% of JIA patients were diarrhea, cough, pyrexia, and abdominal pain. In general, the adverse events in JIA and adult PsA patients were similar in frequency and type to those seen in adult RA patients.
Note concerning ORENCIA administration options: Intravenous dosing has not been studied in patients younger than 6 years of age. The safety and efficacy of ORENCIA ClickJect™ Autoinjector for subcutaneous injection has not been studied in patients under 18 years of age.
Please click here to see the Full Prescribing Information.
About Bristol-Myers Squibb Immunoscience
With a robust pipeline of immunomodulatory therapies, Bristol-Myers Squibb is committed to the discovery and development of transformational medicines for patients suffering from immune-mediated disease. As we learn more about the immune system in diseases with substantial unmet medical needs, the potential for new therapies that modulate the immune system continues to drive our research efforts.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2016 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
References
1. ORENCIA® Annex I: Summary of Product Characteristics. Bristol-Myers Squibb Company, Princeton, NJ. June 2017.
2. Psoriatic Arthritis Overview. National Institutes of Health. https://www.niams.nih.gov/Health_info/Psoriatic_Arthritis/default.asp. Accessed May 8, 2017.
3. What is Psoriatic Arthritis? The Arthritis Foundation. http://www.arthritis.org/about-arthritis/types/psoriatic-arthritis/what-is-psoriatic-arthritis.php. Accessed May 8, 2017.
4. Mease P., Gottlieb A., Heijde H., et al. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase 3 study in psoriatic arthritis. Annals of the Rheumatic Diseases. 2017
5. Mease P, Genovese MC, Gladstein G. Abatacept in the treatment of patients with psoriatic arthritis: Results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial. Arthritis & Rheumatism. 2011;63(4):939-948.
6. Psoriatic Arthritis. American College of Rheumatology. https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis. Accessed May 8, 2017.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170726005213/en/
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BMY
Sold LBY @ $7.85 and 50 shares @ 7.90 which did not register on the Level II. Ended up with ~$100 loss after averaging down. Libbey has lost it's bounce and believe can get back in at a lower price prior to earnings.
LBY
Loncar blog has increasingly useful data sets:
http://www.loncarblog.com/
U.S. Food & Drug Administration Expands Approval of Yervoy® (ipilimumab) to Include Pediatric Patients 12 Years & Older with...
Date : 07/24/2017 @ 6:59AM
Source : Business Wire
Yervoy showed a consistent safety profile and comparable drug levels across pediatric and adult patients
First Bristol-Myers Squibb immuno-oncology approval for adolescents 12 years and older reflects the company’s commitment to the pediatric cancer community
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for Yervoy® (ipilimumab) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Yervoy was evaluated in two trials of pediatric patients: a dose-finding study in 33 patients aged two to 21 years with relapsed or refractory solid tumors and an open-label, single-arm trial in 12 adolescents (ages ranging from 12 to 16 years) with previously treated or untreated, unresectable Stage 3 or 4 malignant melanoma. The overall safety profile of Yervoy in children and adolescents was consistent with the safety profile in adults, and similarities in disease between adult and pediatric patients 12 years and older allow for extrapolation of data. Based on a population pharmacokinetic analysis, exposure in adolescents 12 years and older is comparable to that in adults for the approved dose of 3 mg/kg, administered intravenously over 90 minutes every three weeks for a total of four doses.1
Yervoy is associated with a Boxed Warning and can result in severe to fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. Please see below for additional Important Safety Information, including Boxed Warning regarding immune-mediated adverse reactions.
“When my daughter was diagnosed with melanoma, our entire family was devastated,” said Brenda Busby, mother to a 12-year-old patient and pediatric program coordinator, Melanoma Research Foundation. “As someone who has lived with the many challenges of pediatric cancer, I know how important it is for patients and their families who face metastatic melanoma to have access to new therapies.”
“Metastatic melanoma is extremely rare in children and adolescents, which makes it particularly difficult to investigate in clinical trials. Though designing clinical trials in small pediatric populations can be challenging, this group of investigators committed to bringing a new therapy to those in need,” said Lia Gore, MD, University of Colorado School of Medicine and Children’s Hospital of Colorado. “Ipilimumab’s approval represents the culmination of a long effort and gives physicians the ability to expand immuno-oncology – one of the most exciting areas of medicine2 – for the treatment of young adults with metastatic melanoma.”
The U.S. FDA approval for Yervoy in patients 12 years and older with metastatic melanoma marks Bristol-Myers Squibb’s first pediatric indication for an immuno-oncology medicine. The expanded indication builds upon six years of experience with Yervoy, which has been used to treat more than 38,000 adult patients with metastatic melanoma since its first approval.3
“Despite significant advancements in oncology research for adults in recent years, treatment options continue to be limited for pediatric patients with metastatic melanoma,” said Chris Boerner, PhD, president and head of U.S. commercial operations, Bristol-Myers Squibb. “At Bristol-Myers Squibb, we are committed to providing meaningful support to the pediatric oncology community. This latest approval of Yervoy exemplifies our ongoing effort to expand the availability of therapies for younger cancer patients.”
As part of its commitment to children and adolescents with cancer, Bristol-Myers Squibb continues to explore pediatric applications for investigational oncology agents within its broad development program. In addition, Bristol-Myers Squibb supports organizations and initiatives focused on pediatric patients and their families.
About the Yervoy Studies in Pediatric Patients
Yervoy has been evaluated in a total of 45 pediatric patients across two clinical trials. The safety and effectiveness of Yervoy have been established in pediatric patients 12 years and older. The use of Yervoy in this age group is supported by evidence from adequate and well-controlled studies of Yervoy in adults and population pharmacokinetic data demonstrating that the exposure at a dose of 3 mg/kg in the pediatric and adult populations is comparable. In addition, the tumor biology and the course of advanced melanoma is sufficiently similar in adults and pediatric patients 12 years and older to allow extrapolation of data from adults to pediatric patients.
In a dose-finding trial, Yervoy was evaluated in 33 pediatric patients with relapsed or refractory solid tumors. Patients enrolled in the study ranged from two to 21 years of age, with a median age of 13 years, and 20 of the patients were 12 years of age or older. Yervoy was administered at doses of 1, 3, 5 and 10 mg/kg intravenously over 90 minutes every three weeks for four doses and then every 12 weeks thereafter until progression or treatment discontinuation.1
Yervoy was also evaluated in an open-label, single-arm trial in 12 pediatric patients 12 years and older with previously treated or untreated, unresectable Stage 3 or 4 malignant melanoma. Patients received Yervoy 3 mg/kg (four patients) or 10 mg/kg (eight patients) intravenously over 90 minutes every three weeks for four doses.1
Of the 17 patients 12 years of age and older with melanoma treated with Yervoy across both studies, two patients experienced objective responses, including one partial response that was sustained for 16 months.1
The approved dose for Yervoy in pediatric patients with unresectable or metastatic melanoma is 3 mg/kg, administered intravenously over 90 minutes every three weeks for a total of four doses.
About the Population Pharmacokinetic Analysis
Based on a population pharmacokinetic analysis using available pooled data from 565 patients from four phase 2 adult studies (N=521) and two pediatric studies (N=44), body weight normalized clearance of Yervoy is comparable between adult and pediatric subjects.
Indications and Important Safety Information for YERVOY® (ipilimumab)
Indications
YERVOY® (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma in adults and pediatric patients (12 years and older).
YERVOY® (ipilimumab) is indicated for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.
Important Safety Information
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
YERVOY (ipilimumab) can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.
Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function tests, at baseline and before each dose.
Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.
Recommended Dose Modifications
Endocrine: Withhold YERVOY for symptomatic endocrinopathy. Resume YERVOY in patients with complete or partial resolution of adverse reactions (Grade 0-1) and who are receiving <7.5 mg prednisone or equivalent per day. Permanently discontinue YERVOY for symptomatic reactions lasting 6 weeks or longer or an inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day.
Ophthalmologic: Permanently discontinue YERVOY for Grade 2-4 reactions not improving to Grade 1 within 2 weeks while receiving topical therapy or requiring systemic treatment.
All Other Organ Systems: Withhold YERVOY for Grade 2 adverse reactions. Resume YERVOY in patients with complete or partial resolution of adverse reactions (Grade 0-1) and who are receiving <7.5 mg prednisone or equivalent per day. Permanently discontinue YERVOY for Grade 2 reactions lasting 6 weeks or longer, an inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day, and Grade 3 or 4 adverse reactions.
Immune-mediated Enterocolitis
Immune-mediated enterocolitis, including fatal cases, can occur with YERVOY. Monitor patients for signs and symptoms of enterocolitis (such as diarrhea, abdominal pain, mucus or blood in stool, with or without fever) and of bowel perforation (such as peritoneal signs and ileus). In symptomatic patients, rule out infectious etiologies and consider endoscopic evaluation for persistent or severe symptoms. Withhold YERVOY for moderate enterocolitis; administer anti-diarrheal treatment and, if persistent for >1 week, initiate systemic corticosteroids (0.5 mg/kg/day prednisone or equivalent). Permanently discontinue YERVOY in patients with severe enterocolitis and initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). Upon improvement to ≤Grade 1, initiate corticosteroid taper and continue over at least 1 month. In clinical trials, rapid corticosteroid tapering resulted in recurrence or worsening symptoms of enterocolitis in some patients. Consider adding anti-TNF or other immunosuppressant agents for management of immune-mediated enterocolitis unresponsive to systemic corticosteroids within 3-5 days or recurring after symptom improvement. In patients receiving YERVOY 3 mg/kg in Trial 1, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 YERVOY-treated patients (7%) and moderate (diarrhea with up to 6 stools above baseline, abdominal pain, mucus or blood in stool; Grade 2) enterocolitis occurred in 28 YERVOY-treated patients (5%). Across all YERVOY-treated patients (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis. Infliximab was administered to 5 (8%) of the 62 patients with moderate, severe, or life-threatening immune-mediated enterocolitis following inadequate response to corticosteroids. In patients receiving YERVOY 10 mg/kg in Trial 2, Grade 3-5 immune-mediated enterocolitis occurred in 76 patients (16%) and Grade 2 enterocolitis occurred in 68 patients (14%). Seven (1.5%) developed intestinal perforation and 3 patients (0.6%) died as a result of complications.
Immune-mediated Hepatitis
Immune-mediated hepatitis, including fatal cases, can occur with YERVOY. Monitor LFTs (hepatic transaminase and bilirubin levels) and assess patients for signs and symptoms of hepatotoxicity before each dose of YERVOY. In patients with hepatotoxicity, rule out infectious or malignant causes and increase frequency of LFT monitoring until resolution. Withhold YERVOY in patients with Grade 2 hepatotoxicity. Permanently discontinue YERVOY in patients with Grade 3-4 hepatotoxicity and administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When LFTs show sustained improvement or return to baseline, initiate corticosteroid tapering and continue over 1 month. Across the clinical development program for YERVOY, mycophenolate treatment has been administered in patients with persistent severe hepatitis despite high-dose corticosteroids. In patients receiving YERVOY 3 mg/kg in Trial 1, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5× the ULN or total bilirubin elevations >3× the ULN; Grade 3-5) occurred in 8 YERVOY- treated patients (2%), with fatal hepatic failure in 0.2% and hospitalization in 0.4%. An additional 13 patients (2.5%) experienced moderate hepatotoxicity manifested by LFT abnormalities (AST or ALT elevations >2.5× but ≤5× the ULN or total bilirubin elevation >1.5× but ≤3× the ULN; Grade 2). In a dose-finding trial, Grade 3 increases in transaminases with or without concomitant increases in total bilirubin occurred in 6 of 10 patients who received concurrent YERVOY (3 mg/kg) and vemurafenib (960 mg BID or 720 mg BID). In patients receiving YERVOY 10 mg/kg in Trial 2, Grade 3-4 immune- mediated hepatitis occurred in 51 patients (11%) and moderate Grade 2 immune-mediated hepatitis occurred in 22 patients (5%). Liver biopsy performed in 6 patients with Grade 3-4 hepatitis showed evidence of toxic or autoimmune hepatitis.
Immune-mediated Dermatitis
Immune-mediated dermatitis, including fatal cases, can occur with YERVOY. Monitor patients for signs and symptoms of dermatitis such as rash and pruritus. Unless an alternate etiology has been identified, signs or symptoms of dermatitis should be considered immune-mediated. Treat mild to moderate dermatitis (e.g., localized rash and pruritus) symptomatically; administer topical or systemic corticosteroids if there is no improvement within 1 week. Withhold YERVOY in patients with moderate to severe signs and symptoms. Permanently discontinue YERVOY in patients with severe, life- threatening, or fatal immune-mediated dermatitis (Grade 3-5). Administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When dermatitis is controlled, corticosteroid tapering should occur over a period of at least 1 month. In patients receiving YERVOY 3 mg/kg in Trial 1, severe, life- threatening, or fatal immune-mediated dermatitis (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 YERVOY-treated patients (2.5%); 1 patient (0.2%) died as a result of toxic epidermal necrolysis and 1 additional patient required hospitalization for severe dermatitis. There were 63 patients (12%) with moderate (Grade 2) dermatitis. In patients receiving YERVOY 10 mg/kg in Trial 2, Grade 3-4 immune-mediated dermatitis occurred in 19 patients (4%).
There were 99 patients (21%) with moderate Grade 2 dermatitis.
Immune-mediated Neuropathies
Immune-mediated neuropathies, including fatal cases, can occur with YERVOY. Monitor for symptoms of motor or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, or paresthesia. Withhold YERVOY in patients with moderate neuropathy (not interfering with daily activities). Permanently discontinue YERVOY in patients with severe neuropathy (interfering with daily activities), such as Guillain-Barre-like syndromes. Institute medical intervention as appropriate for management for severe neuropathy. Consider initiation of systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe neuropathies. In patients receiving YERVOY 3 mg/kg in Trial 1, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported. Across the clinical development program of YERVOY, myasthenia gravis and additional cases of Guillain-Barré syndrome have been reported. In patients receiving YERVOY 10 mg/kg in Trial 2, Grade 3-5 immune-mediated neuropathy occurred in 8 patients (2%); the sole fatality was due to complications of Guillain-Barré syndrome. Moderate Grade 2 immune-mediated neuropathy occurred in 1 patient (0.2%).
Immune-mediated Endocrinopathies
Immune-mediated endocrinopathies, including life-threatening cases, can occur with YERVOY. Monitor patients for clinical signs and symptoms of hypophysitis, adrenal insufficiency (including adrenal crisis), and hyper- or hypothyroidism. Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease. Unless an alternate etiology has been identified, signs or symptoms should be considered immune-mediated. Monitor clinical chemistries, adrenocorticotropic hormone (ACTH) level, and thyroid function tests at the start of treatment, before each dose, and as clinically indicated based on symptoms. In a limited number of patients, hypophysitis was diagnosed by imaging studies through enlargement of the pituitary gland. Withhold YERVOY in symptomatic patients and consider referral to an endocrinologist. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) and initiate appropriate hormone replacement therapy. In patients receiving YERVOY 3 mg/kg in Trial 1, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 YERVOY-treated patients (1.8%). All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were hospitalized for severe endocrinopathies. Moderate endocrinopathy (requiring hormone replacement or medical intervention; Grade 2) occurred in 12 patients (2.3%) and consisted of hypothyroidism, adrenal insufficiency, hypopituitarism, and 1 case each of hyperthyroidism and Cushing's syndrome. The median time to onset of moderate to severe immune-mediated endocrinopathy was 2.5 months and ranged up to 4.4 months after the initiation of YERVOY. In patients receiving YERVOY 10 mg/kg in Trial 2, Grade 3-4 immune-mediated endocrinopathies occurred in 39 patients (8%) and Grade 2 immune-mediated endocrinopathies occurred in 93 patients (20%). Of the 39 patients with Grade 3-4 immune-mediated endocrinopathies, 35 patients had hypopituitarism (associated with 1 or more secondary endocrinopathies, e.g., adrenal insufficiency, hypogonadism, and hypothyroidism), 3 patients had hyperthyroidism, and 1 had primary hypothyroidism. The median time to onset of Grade 3-4 immune-mediated endocrinopathy was 2.2 months (range: 2 days-8 months). Twenty-seven (69.2%) of the 39 patients were hospitalized for immune-mediated endocrinopathies. Of the 93 patients with Grade 2 immune-mediated endocrinopathy, 74 had primary hypopituitarism (associated with 1 or more secondary endocrinopathy, e.g., adrenal insufficiency, hypogonadism, and hypothyroidism), 9 had primary hypothyroidism, 3 had hyperthyroidism, 3 had thyroiditis with hypo- or hyperthyroidism, 2 had hypogonadism, 1 had both hyperthyroidism and hypopituitarism, and 1 subject developed Graves’ ophthalmopathy. The median time to onset of Grade 2 immune-mediated endocrinopathy was 2.1 months (range: 9 days-19.3 months).
Other Immune-mediated Adverse Reactions, Including Ocular Manifestations
Permanently discontinue YERVOY for clinically significant or severe immune-mediated adverse reactions. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe immune-mediated adverse reactions. Administer corticosteroid eye drops for uveitis, iritis, or episcleritis. Permanently discontinue YERVOY for immune-mediated ocular disease unresponsive to local immunosuppressive therapy. In Trial 1, the following clinically significant immune-mediated adverse reactions were seen in <1% of YERVOY-treated patients: nephritis, pneumonitis, meningitis, pericarditis, uveitis, iritis, and hemolytic anemia. In Trial 2, the following clinically significant immune- mediated adverse reactions were seen in <1% of YERVOY-treated patients unless specified: eosinophilia (2.1%), pancreatitis (1.3%), meningitis, pneumonitis, sarcoidosis, pericarditis, uveitis and fatal myocarditis. Across 21 dose-ranging trials administering YERVOY at doses of 0.1 to 20 mg/kg (n=2478), the following likely immune-mediated adverse reactions were also reported with <1% incidence: angiopathy, temporal arteritis, vasculitis, polymyalgia rheumatica, conjunctivitis, blepharitis, episcleritis, scleritis, iritis, leukocytoclastic vasculitis, erythema multiforme, psoriasis, arthritis, autoimmune thyroiditis, neurosensory hypoacusis, autoimmune central neuropathy (encephalitis), myositis, polymyositis, ocular myositis, hemolytic anemia, and nephritis.
Embryo-fetal Toxicity
Based on its mechanism of action, YERVOY can cause fetal harm when administered to a pregnant woman. The effects of YERVOY are likely to be greater during the second and third trimesters of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with a YERVOY-containing regimen and for 3 months after the last dose of YERVOY.
Lactation
It is not known whether YERVOY is secreted in human milk. Advise women to discontinue nursing during treatment with YERVOY and for 3 months following the final dose.
Common Adverse Reactions
The most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%). The most common adverse reactions (≥5%) in patients who received YERVOY at 10 mg/kg were rash (50%), diarrhea (49%), fatigue (46%), pruritus (45%), headache (33%), weight loss (32%), nausea (25%), pyrexia (18%), colitis (16%), decreased appetite (14%), vomiting (13%), and insomnia (10%).
Please see U.S. Full Prescribing Information for YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions.
Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research
At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines for hard-to-treat cancers that could potentially improve outcomes for these patients.
We are leading the scientific understanding of I-O through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 50 types of cancers with 14 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance the I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O radiation therapies across multiple tumors and potentially deliver the next wave of therapies with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how a patient’s tumor biology can be used as a guide for treatment decisions throughout their journey.
We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.
About Yervoy
Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types.
About Bristol-Myers Squibb’s Patient Access Support
Bristol-Myers Squibb remains committed to providing a comprehensive set of programs and services so that cancer patients who need our medicines can access them and expedite time to therapy.
BMS Access Support®, the Bristol-Myers Squibb Patient Access and Reimbursement Services program, is designed to help appropriate patients initiate and maintain access to BMS medicines during their treatment journey. BMS Access Support offers benefit investigation, prior authorization assistance and co-pay assistance for eligible, commercially insured patients. More information about our access and reimbursement support services can be obtained by calling BMS Access Support® at 1-800-861-0048 or by visiting www.bmsaccesssupport.com.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2016 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
1 Yervoy Prescribing Information. Yervoy U.S. Product Information. Last updated: July 2017. Princeton, NJ: Bristol-Myers Squibb Company.
2 Eggermont AM. Can immuno-oncology offer a truly pan-tumour approach to therapy? Ann Oncol. 2012 Sep; 23 Suppl 8:viii53-7.
3 IMS APLD data. April 2011-April 2017.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170724005308/en/
Bristol-Myers Squibb Company
Media:
Laurel Sacks, 609-302-5456
Cell: 917-861-0746
laurel.sacks@bms.com
or
Investors:
Bill Szablewski, 609-252-5894
william.szablewski@bms.com
or
Tim Power, 609-252-7509
timothy.power@bms.com
___________________________________________________
BMY
From what I read on Twitter most are incredulous of the trading going on as the news was not that important and the date is over 5 months from now.
My guess is low float and they are selling the ATM which they had filed months ago. When selling you sure can influence the price to an extent, but have got to assume by now the shelf has been sold.
AEZS seems to always have these annual bursts but this one seems to be going on longer. Got to look at the last CRL which was devastating. I'd assume none of the traders now have any concerns regarding the company and fundamentals, just trade what is hot.
AEZS
Sarepta Therapeutics and BioMarin Pharmaceutical Inc. Announce Execution of a Global Settlement and a License Agreement Resolving Exon Skipping Patent Litigation
Agreement terms resolve global patent proceedings regarding Sarepta’s sale of EXONDYS 51® (eteplirsen) and future Duchenne muscular dystrophy (DMD) exon-skipping products
July 18, 2017 08:30 ET | Source: Sarepta Therapeutics
CAMBRIDGE, Mass. and SAN RAFAEL, Calif., July 18, 2017 (GLOBE NEWSWIRE) --
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a U.S. commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases, and BioMarin Pharmaceutical Inc. (NASDAQ:BMRN), a leading biotechnology company in therapies for rare genetic diseases, announced today that Sarepta and BioMarin executed a license agreement that provides Sarepta Therapeutics with global exclusive rights to BioMarin’s DMD patent estate for EXONDYS 51 and all future exon-skipping products. BioMarin retains the right to convert the license to a co-exclusive right in the event it decides to proceed with an exon-skipping therapy for DMD. In addition, Sarepta and BioMarin executed a settlement agreement, resolving the ongoing worldwide patent proceedings related to the use of EXONDYS 51 and all future exon-skipping products for the treatment of DMD. The effectiveness of the agreements is subject to closing conditions including execution of necessary approvals by Academisch Ziekenhuis Leiden (AZL) by July 24, 2017.
Under the terms of the license and settlement agreements, Sarepta will make a one-time payment of $35 million to BioMarin and certain additional regulatory and commercial milestone payments for exons 51, 45, 53 and possibly on future exon-skipping products.
In addition, Sarepta will pay royalties to BioMarin as follows:
Exon-skipping compounds 51, 45, and 53 and possibly on future exon-skipping products: Sarepta will pay BioMarin 5 percent of net sales through the end of 2023 in the United States; and
Exon-skipping compounds 51, 45, and 53 and possibly on future exon-skipping products: Sarepta will pay BioMarin 8 percent of net sales through September 30, 2024 in the European Union and in other countries where certain BioMarin / AZL patents exist.
“Upon their effectiveness, these global license and settlement agreements provide Sarepta worldwide freedom to operate for EXONDYS 51 and our future exon-skipping products,” said Douglas Ingram, Sarepta’s President and Chief Executive Officer. “The resolution of these legal matters provides us with more certainty to fully focus our resources and energy on our crucial mission of developing innovative medicines to improve the lives of those impacted by DMD around the world."
“We are pleased to reach a global settlement and license agreement with Sarepta that fairly recognizes the important innovation by the Leiden University Medical Center and allows patients certainty that this issue will not create a barrier to access,” said G. Eric Davis, BioMarin’s Executive Vice President and General Counsel.
About EXONDYS 51
EXONDYS 51 uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to skip exon 51 of the dystrophin gene. EXONDYS 51 is designed to bind to exon 51 of dystrophin pre-mRNA, resulting in exclusion of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 51 skipping. Exon skipping is intended to allow for production of an internally truncated dystrophin protein. Data from clinical studies of EXONDYS 51 in a small number of DMD patients have demonstrated a consistent safety and tolerability profile. The pivotal trials were not designed to evaluate long-term safety and a clinical benefit of EXONDYS 51 has not been established.
Important Safety Information
Adverse reactions in DMD patients (N=8) treated with EXONDYS 51 30 or 50 mg/kg/week by intravenous (IV) infusion with an incidence of at least 25% more than placebo (N=4) (Study 1, 24 weeks) were (EXONDYS 51, placebo): balance disorder (38%, 0%), vomiting (38%, 0%) and contact dermatitis (25%, 0%). The most common adverse reactions were balance disorder and vomiting. Because of the small numbers of patients, these represent crude frequencies that may not reflect the frequencies observed in practice. The 50 mg/kg once weekly dosing regimen of EXONDYS 51 is not recommended.
In the 88 patients who received ≥30 mg/kg/week of EXONDYS 51 for up to 208 weeks in clinical studies, the following events were reported in ≥10% of patients and occurred more frequently than on the same dose in Study 1: vomiting, contusion, excoriation, arthralgia, rash, catheter site pain, and upper respiratory tract infection.
There have been reports of transient erythema, facial flushing, and elevated temperature occurring on the day of EXONDYS 51 infusion.
About Sarepta Therapeutics
Sarepta Therapeutics is a U.S. commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The company is primarily focused on rapidly advancing the development of its potentially disease-modifying Duchenne muscular dystrophy (DMD) drug candidates. For more information, please visit www.sarepta.com.
About BioMarin Pharmaceutical Inc.
BioMarin is a global biotechnology company that develops and commercializes innovative therapies for people with serious and life-threatening rare disorders. The company's portfolio consists of six commercialized products and multiple clinical and pre-clinical product candidates. For additional information, please visit www.biomarin.com. Information on BioMarin's website is not incorporated by reference into this press release.
Forward-Looking Statements
This press release contains statements that are forward-looking. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements about the license agreement providing Sarepta with global exclusive rights to BioMarin’s DMD patent estate for EXONDYS 51 and all future exon-skipping products; the settlement agreement resolving the ongoing worldwide patent proceedings related to the use of EXONDYS 51 and all future exon-skipping products for the treatment of DMD; the payments and royalties that Sarepta will be making as part of the settlement and license agreements; the settlement and license agreements providing for Sarepta's worldwide freedom to operate for EXONDYS 51 and Sarepta’s future exon-skipping products; the settlement providing Sarepta with the certainty to fully focus its resources and energy on its crucial mission of developing innovative medicines to improve the lives of those impacted by DMD around the world; and the statement that the patent proceedings between the parties will not create for patients a barrier to access to the innovation by the Leiden University Medical Center.
These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta's control. Known risk factors include, among others: the settlement and license agreements may not become effective if their conditions to effectiveness are not met within the required deadline; the parties may not be able to fulfill their commitments and obligations under the settlement and license agreements; any future claims of infringement by other third parties; the expected benefits and opportunities related to the settlement and license agreements between the parties may not be realized or may take longer to realize than expected due to challenges and uncertainties regarding the sales of EXONDYS 51 and the research and development of future exon-skipping products; Sarepta may experience significant fluctuations in sales of EXONDYS 51 from period to period and, ultimately, Sarepta may never generate sufficient revenues from EXONDYS 51 to reach or maintain profitability or sustain its anticipated levels of operations; Sarepta may never receive regulatory approval to its future exon-skipping products due to a variety of reasons including that the results of additional research may not be consistent with past results or may not be positive or may otherwise fail to meet regulatory approval requirements for the safety and efficacy of product candidates; and even if Sarepta obtains regulatory approvals, it may not achieve any significant revenues from the sale of such products; Sarepta may not have worldwide freedom to operate for EXONDYS 51 and Sarepta’s future exon-skipping products due to future proceedings brought by other parties.
Any of the foregoing risks could adversely affect Sarepta's business, results of operations and the trading price of Sarepta's common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review Sarepta's 2016 Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.
Internet Posting of Information
We routinely post information that may be important to investors in the 'For Investors' section of our website at www.sarepta.com. We encourage investors and potential investors to consult our website regularly for important information about us.
Source: Sarepta Therapeutics, Inc.
Media and Investors:
Sarepta Therapeutics, Inc.
Ian Estepan, 617-274-4052
iestepan@sarepta.com
or
W2O Group
Brian Reid, 212-257-6725
breid@w2ogroup.com
or
Investors:
BioMarin Pharmaceutical Inc.
Traci McCarty, 415-455-7558
Media:
BioMarin Pharmaceutical Inc.
Debra Charlesworth, 415-455-7451
______________________________________________
BMRN
Wrong choice. Hugh volume today and now near the 3 month low on no news and biotech up marginally.
BMRN
In BMRN @ $88.80 today. Hadn't traded it for over 3 years.
A Baker Bro stock with limited up potential:
Consensus Ratings for BioMarin Pharmaceutical (NASDAQ:BMRN) (How are Consensus Ratings Calculated?)
Ratings Breakdown: 6 Hold Ratings, 14 Buy Ratings
Consensus Rating: Buy (Score: 2.70)
Consensus Price Target: $113.61 (24.85% upside)
_______________________________________
https://www.marketbeat.com/stocks/NASDAQ/BMRN/
Very long time and notable director < http://www.reuters.com/finance/stocks/officerProfile?symbol=BMY&officerId=28442 >
I see they are limiting the number of directors to 10. Maybe something to do with Carl Icahn?
BMY
Out at $9.60. But way stronger than had anticipated as it has continued to go up to the HOD.
Much potential and hope to get back in if/when it begin to fill the gap. It seems that this is so thinly traded that it will revisit the gap.
EIGR
BTIG Starts Eiger BioPharma (EIGR) at Buy
July 14, 2017 7:31 AM EDT
BTIG initiates coverage on Eiger BioPharma (NASDAQ: EIGR) with a Buy rating and a price target of $32.00.Analyst Robert Hazlett
_________________________________________________________
Consensus Ratings for Eiger BioPharmaceuticals (NASDAQ:EIGR) (How are Consensus Ratings Calculated?)
Ratings Breakdown: 5 Buy Ratings
Consensus Rating: Buy (Score: 3.00)
Consensus Price Target: $32.75 (339.60% upside)
_________________________________________________________
https://www.marketbeat.com/stocks/NASDAQ/EIGR/
EIGR
MMs sure made some money in the last hour. The connection and threat to BMY worth seems to be very insignificant especially relative to the CAR-T companies.
I believe that there is a market sentiment to go bearish on BMY whenever there is doubt.
I could believe that clever shorts might have engineered a selloff and were waiting for the results. Would BMY had gone up with a negative vote? Never.
BMY
Ah-ha they're competing treatment for diffuse large B-cell lymphoma (DLBCL).
But, BMY has moved much more than NVS, JUNO and BLUE.
Opportunistic trading.
BMY
Never thought NVS vote would have such influence on BMY:
Adam Feuerstein?Verified account @adamfeuerstein 16m16 minutes ago
More
The $NVS CTL019 vote:
10 YES
0 NO
_______________________________________
Straight down from HOD @ $56.24.
BMY
Bullish SA article:
___________________________________________________________
Bristol-Myers Squibb: Strong Fundamentals Suggest Shares Are Undervalued
Jul. 10, 2017 8:47 AM ET| About: Bristol-Myers Squibb Company (BMY)
Hudson River Capital Research
(415 followers)
Summary
Bristol Myers is still seeing remarkable revenue and earnings growth.
With a dividend yield of 2.8 percent and has a low P/E ratio relative to the industry average, shares look undervalued.
Even with Opdivo failing its phase 3 trial last year, Bristol Myers still has a large and well diversified pipeline.
Bristol Myers solid balance sheet and low valuation makes them the perfect buyout target.
Bristol-Myers Squibb (BMY) is an American pharmaceutical company which has been operating for well over a century. Their pipeline consists of innovative oncology, cardiovascular, immunology and fibrosis treatments, however, they are most well known for their immuno-oncology (I/O) cancer treatment drug Opdivo. This focus on immunology therapies has payed off very well, Opdivo and Yervoy are both I/O drugs which have been cash cows since their respective approvals. With this being said, Bristol-Myers is not just an cancer treatment company, they have approved drugs in disease areas other than cancer and have a large diversified developing portfolio of drugs. However, near the end of 2016, Bristol-Myers stock plummeted after their I/O drug, Opdivo, failed to impress in a phase 3 lung cancer trial. Shares dropped over 20 percent in reaction to this news, it was a overextended sell off which has left Bristol-Myer's share price in a depressed state ever since.
Investment Thesis
It has been nearly a year since that happened now, and we believe shares are now fundamentally undervalued. Bristol-Myer's strong fundamentals has allowed them to operate and survive for over 100 years. With a cheap valuation, strong earnings growth, and a pipeline with limitless potential, there is a possibility Bristol-Myers could even be the subject of a takeover acquisition which would create immense shareholder value. For dividend investors, Bristol-Myers is also a solid company to hold due to their 2.8 percent dividend yield.
Revenue and Earnings Growth
If we break down Bristol-Myer's sales from the last quarter, we can find some really remarkable numbers. With so much negativity about the future of Opdivo after its lung cancer trial setback, it is still seeing strong sales growth. In fact, All of Bristol Myer's prioritized brands have seen revenue growth in the double digits. Opdivo generated the most revenue for Bristol Myers totaling $1,127,000,000 in sales revenue last quarter, a 60 percent increase year over year. Eliquis trailed behind in revenue by just a few million coming in at $1,101,000,000 for the quarter, a 50 percent increase year over year. Yervoy saw a 25 percent growth in sales revenue year over year, bringing in over $330,000,000 in sales. Orencia and Sprycel brought in $535,000,000 and $463,000,000 respectively, Orencia saw a 13 percent increase in sales year over year and Sprycel saw a 14 percent increase in sales year over year. Most interestingly, Empliciti sales nearly doubled growing 89 percent year over year for the first quarter. Even when you take into consideration that the total sales revenue of Empliciti was a modest $28 million for the last quarter, it is important to take note of this great sales growth trend. Many analysts believe that Empliciti has the potential to become a blockbuster drug in the future, it will be very important for shareholders to watch the drug closely in the following quarters to come.
Bristol-Myer's saw a 12 percent increase in sales revenue year over year and generated 1.6 billion dollars in net earnings last quarter, not bad at all for such a large and well established pharmaceutical giant. During the same quarter last year, Bristol Myers only generated 1.2 billion dollars in earnings, net earnings are up over 25 percent since then. As a cherry on top, yearly guidance for both revenue and EPS was increased after their strong earnings report. That was just one quarter though, it is also very important to look at the bigger picture.
(click link for charts/tables)
Source
The graph above is the consensus revenue and earnings projections of 14 analysts for Bristol-Myers. If the estimates hold up, Bristol-Myer's profits could come close to doubling by 2021. Due to the competitive nature of the pharmaceutical industry, these projections can be far from reality. There is no way to predict if there will be any new drugs in the future that can suddenly threaten any of Bristol-Myer's drugs. Fortunately, Bristol-Myers has a large pipeline that is full of untapped potential.
Pipeline
Bristol-Myers' pipeline focuses on 4 main areas, oncology, autoimmune diseases, fibrosis and cardiovascular diseases. As of June, there are 31 compounds in Bristol's pipeline undergoing clinical trials. 30 of those drugs are either in phase 1 or 2 testing, Prostvac is the only drug in phase 3 testing. Prostvac is an immunotherapy vaccine currently being evaluated in a phase 3 trial for the treatment of castration-resistant prostate cancer, topline data from this trial is expected near the year end. 11 of the 30 compounds are in phase 2 testing with the remaining 19 compounds in phase 1 testing. While it is true that most of the drugs in Bristol's pipeline are in early clinical testing, by the end of 2020 this pipeline will start to mature and produce potential blockbuster drug candidates. Bristol's pipeline right now should be seen as a relatively new basket of eggs, just because they are not close to hatching, it does not mean it is somehow any worse then a normal basket. Not only does Bristol's basket of eggs have a lot of potential but this basket of eggs is also well diversified. The pipeline consists of two cardiovascular disease treatment compounds, 5 fibrosis treatment compounds, 8 autoimmune treatment compounds and 16 anti-cancer compounds. A well diversified pipeline makes it easy for Bristol to capitalize on increasing demand from multiple different disease areas ranging from prostate cancer to rheumatoid arthritis. There is no doubt that it will take time for this pipeline to mature, but in the mean time, investors can enjoy Bristol Myer's steady dividend.
Valuation and Dividend
One of the most attractive things about Bristol-Myer's stock is the undervalued price it is currently trading at. With a P/E ratio of 19.3, Bristol-Myers is below the pharmaceutical industry average of 23.6. Bristol-Myer's is also trading at a low price to book ratio of 6.4, also below the industry average. (All P/E ratios and PB ratios are from Simply Wall Street)
(click link for charts/tables)
Source
Bristol-Myers had a return on equity of 33.2 percent last year, a return on assets of 12.2 percent and a return on capital of 26 percent. For each 3 of these metrics, Bristol-Myers exceeded the industry average, with such strong performance, it is surprising that they are not trading at a higher valuation. Bristol-Myers is a great stock pick for value investors, their stock price trades at a price to earnings ratio which is below the industry average while outperforming the industry on several key earnings metrics.
For dividend investors, Bristol-Myers is also a solid investment choice. Since 2010, Bristol-Myers has increased its dividend for the past 7 consecutive years. Currently, their annualized dividend is $1.56, which is a yield of around 2.8 percent. Their payout ratio is 53.2 percent, not too high but not too low at the same time. As long as they continue to post strong earnings, there is no reason why their dividend will not be increased in the future. Some might argue that their payout ratio should be higher actually, but I believe around 50 percent is the perfect ratio. Bristol-Myers spends a lot on developing their pipeline and marketing their drugs to make them competitive, you first have to be able to generate earnings before you can give cash back to your shareholders. It is important to not focus too much on generating short term shareholder returns and instead focus on the bigger picture. Bristol-Myers will spend their cash wisely in order to grow the company while giving back a good amount to their shareholders, they will not make the same mistakes Gilead (NASDAQ:GILD) as made in the past. A stocks dividend payout is one of the most important factors to take into consideration, we believe Bristol-Myer's dividend is extremely appealing for investors who have a dividend investing style.
Buyout Speculation?
Although it is never a good idea to speculate, I think there are some valid points which can be made to support the idea that Bristol Myers might be bought out in the future. This idea started gaining traction in February when the famous activist investor, Carl Icahn, announced that he had an equity stake in Bristol-Myers. People thought that he would try to help push through a buyout of Bristol-Myers or a potential merger. Icahn is not the only activist investor with a stake in Bristol Myers though, Jana Partners has a large equity stake as well. This pressure from Icahn and Jana makes a buyout or merger much more likely.
When you think about it, Bristol-Myers would be the perfect mega acquisition target to acquire. They have a solid balance sheet with not too much debt, the debt they have is well covered by their annual operating cash flow. Bristol's well established pipeline is also very attractive to pharmaceutical companies looking to enter the I/O market.
(click link for charts/tables)
Source- (Eli Lilly (LLY) and Bristol Myers go back and forth from 8th-9th)
It is also important to note how cheap Bristol-Myer's shares are now. In the past, Bristol-Myers was the largest pharmaceutical company in the US, now it hovers around the 8th-9th position. Opdivo's disappointing data versus lung cancer have caused shares to tumble from all time highs and not recover. With Bristol trading at such a low valuation as a result, they are the perfect merger/buyout target.
Conclusion
Even if you do not believe in a possibility of a buyout or merger, the bottom line is that Bristol-Myers Squibb is a fundamentally sound company. Even with the Opdivo lung cancer setback, they are still generating impressive earnings and revenue growth. Their valuation is still low and it is not too late to pick up some shares in this century old company. With a dividend yield of 2.8 percent as well, Bristol-Myers is a solid bet for dividend investors too.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
__________________________________________________
https://seekingalpha.com/article/4086597-bristol-myers-squibb-strong-fundamentals-suggest-shares-undervalued?app=1&auth_param=udil:1cm6trn:40a7c2a2ca3f17eaf6ef1890e568667f&uprof=46
BMY
Bristol-Myers Squibb’s ORENCIA (abatacept) Receives FDA Approval for Treatment of Active Psoriatic Arthritis (PsA) in Adults
Date : 07/06/2017 @ 7:30AM
Source : Business Wire
ORENCIA demonstrated symptom improvement in two randomized, double-blind, placebo-controlled trials that included adult PsA patients with active musculoskeletal symptoms
ORENCIA now approved in three autoimmune diseases
Bristol-Myers Squibb Company (NYSE:BMY) announced today the U.S. Food and Drug Administration (FDA) has approved ORENCIA for the treatment of adults with active Psoriatic Arthritis (PsA)1, a chronic2, inflammatory disease that can affect both the skin and musculoskeletal system.3 ORENCIA is approved and available in both intravenous and subcutaneous (SC) injection formulations.1 ORENCIA should not be administered concomitantly with TNF antagonists, and is not recommended for use concomitantly with other biologic Rheumatoid Arthritis (RA) therapy, such as anakinra.1 This approval marks the third autoimmune disease indication for ORENCIA.1
“This approval underscores the efficacy of ORENCIA in adult patients with active Psoriatic Arthritis, who have been in need of new treatments,” said Brian J. Gavin, Vice President, ORENCIA Development Lead at Bristol-Myers Squibb. “Helping to advance clinical understanding of autoimmune conditions is a key focus of our immunoscience research, and we’re proud to introduce ORENCIA, a selective T-cell co-stimulation modulator, as an additional treatment option for PsA.”
The co-stimulation blockade of ORENCIA inhibits T-cell activation and the resulting cascade of events that contribute to inflammation. T-cell activation is involved in the pathogenesis of PsA.4
Psoriatic Arthritis can cause joint pain, stiffness and reduced range of motion3, potentially affecting the ability to do everyday activities, such as getting dressed and tying shoes.3,5 In PsA, the immune system attacks healthy joints and skin.6
“Psoriatic Arthritis takes a toll on patients and families over time,7” said Randy Beranek, president and CEO, National Psoriasis Foundation. “We welcome the introduction of an additional treatment option for adults with active Psoriatic Arthritis, because we believe advancements, along with further research, education and support services, are critical to helping improve the lives of those impacted.”
The approval was based on results from two randomized, double-blind, placebo-controlled trials in which ORENCIA improved (or reduced) disease activity in both TNF-naive and exposed patients with high disease activity, high tender and swollen joints, and a disease duration of more than seven years.1,4,8
ORENCIA PsA IV and SC Studies Demonstrated Improved Disease Response
The efficacy of ORENCIA was assessed in two randomized, double-blind, placebo-controlled studies (Studies PsA-I and PsA-II) in 594 adult patients with disease duration more than seven years. Patients had active Psoriatic Arthritis (≥ 3 swollen joints and ≥ 3 tender joints) despite prior treatment with DMARD therapy and had one qualifying psoriatic skin lesion of at least 2 cm in diameter. In PsA-I and PsA-II, 37% and 61% of patients, respectively, were treated with TNF inhibitors (TNFi) previously.1 The primary endpoint for both PsA-I and PsA-II was the proportion of patients achieving ACR 20 response at Week 24 (Day 169).1
In PsA-I, a dose-ranging study, 170 patients received study drug IV at Days 1, 15, 29, and then every 28 days thereafter in a double-blind manner for 24 weeks, followed by open-label ORENCIA every 28 days. Patients were randomized to receive placebo or ORENCIA 3 mg/kg, 10 mg/kg (weight range-based dosing: 500 mg for patients weighing less than 60 kg, 750 mg for patients weighing 60 to 100 kg, and 1000 mg for patients weighing greater than 100 kg), or two doses of 30 mg/kg followed by weight range-based dosing of 10 mg/kg without escape for 24 weeks. Patients were allowed to receive stable doses of concomitant methotrexate, low dose corticosteroids (equivalent to ≤ 10 mg of prednisone) and/or NSAIDs during the trial. At enrollment, approximately 60% of patients were receiving methotrexate.1
In PsA-II, 424 patients were randomized 1:1 to receive weekly doses of SC placebo or ORENCIA 125 mg SC without a loading dose for 24 weeks, followed by open-label ORENCIA 125 mg SC weekly. Patients were allowed to receive stable doses of concomitant methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, low dose corticosteroids (equivalent to ≤ 10 mg of prednisone) and/or NSAIDs during the trial. At randomization, 60.4% of patients were receiving methotrexate.1
A higher proportion of patients treated with ORENCIA 10 mg/kg IV or 125 mg SC achieved an ACR20 response at Week 24 compared to placebo, 47.5% versus 19.0% and 39.4% versus 22.3% (p< 0.05), respectively.1 Responses were seen regardless of prior anti-TNFi treatment and regardless of concomitant non-biologic DMARD treatment.1 Improvements in enthesitis and dactylitis were seen with ORENCIA treatment at Week 24 in both IV and SC.1
There was a higher proportion of ORENCIA IV patients with at least a 0.30 decrease from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) score at Week 24, with an estimated difference for ORENCIA 10 mg/kg (weight range-based dosing as described above) (45.0%) vs. placebo (19.0%) of 26.1 (95% confidence interval: 6.8, 45.5).1 The proportion of ORENCIA SC patients with at least a 0.35 decrease from baseline in HAQ-DI on ORENCIA was 31%, as compared to 24% on placebo (estimated difference: 7%; 95% confidence interval: -1%, 16%).1 There was a higher adjusted mean change from baseline in HAQ-DI on ORENCIA SC (-0.33) vs. placebo (-0.20) at Week 24, with an estimated difference of -0.13 (95% confidence interval: -0.25, -0.01). 1
The safety profile of ORENCIA was comparable between studies PsA-I and PsA-II and consistent with the safety profile in RA. The most serious adverse reactions reported in studies of adult RA patients were serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo). Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events (≥ 10%) in the adult RA clinical studies. In PsA-II, the most common adverse reactions (≥ 5%) were nasopharyngitis, upper respiratory tract infection, and bronchitis.
“It can be difficult to treat active Psoriatic Arthritis patients because the disease course is unpredictable, and patients are often treated with a variety of medications such as classic DMARDs and TNFs over time.4 Furthermore, once they have been treated, it may be more difficult to obtain an adequate efficacy response,” said Philip Mease, M.D., Clinical Professor at the University of Washington School of Medicine and Director of the Rheumatology Clinical Research Division of Swedish Medical Center. “The data that formed the basis of this approval demonstrate that ORENCIA offers an additional treatment option for patients with active Psoriatic Arthritis who have already tried a TNF inhibitor, as well as those who have not.”
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic2, inflammatory disease that can affect both the skin and musculoskeletal system.3 PsA can cause joint pain, stiffness and reduced range of motion.3 Most commonly affecting the distal joints (those closest to the nail) of the fingers or toes, as well as the wrists, knees, ankles and lower back, the disease usually appears between the ages of 30 to 50, but can begin as early as childhood.3 Men and women are equally at risk.3 Early recognition, diagnosis and treatment of Psoriatic Arthritis are critical to helping relieve pain and inflammation.3
Indication and Important Safety Information for ORENCIA® (abatacept)
Indication and Usage
Adult Rheumatoid Arthritis (RA): ORENCIA® (abatacept) is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. ORENCIA may be used as monotherapy or concomitantly with disease-modifying, anti-rheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists.
Juvenile Idiopathic Arthritis (JIA): ORENCIA® (abatacept) is indicated for reducing signs and symptoms in patients 2 years of age and older with moderately to severely active polyarticular JIA. ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX).
Adult Psoriatic Arthritis (PsA): ORENCIA® (abatacept) is indicated for the treatment of adult patients with active PsA.
Important Limitations of Use: ORENCIA should not be administered concomitantly with TNF antagonists, and is not recommended for use concomitantly with other biologic RA therapy, such as anakinra.
Important Safety Information for ORENCIA® (abatacept)
Concomitant Use with TNF Antagonists: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult RA patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63%) and serious infections (4.4%) compared to patients treated with only TNF antagonists (43% and 0.8%, respectively), without an important enhancement of efficacy.
Hypersensitivity: Anaphylaxis or anaphylactoid reactions can occur during or after an infusion and can be life-threatening. There were 2 cases (<0.1%; n=2688) of anaphylaxis or anaphylactoid reactions in clinical trials with adult RA patients treated with intravenous ORENCIA. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in <0.9% of patients. There was one case of a hypersensitivity reaction with ORENCIA in JIA clinical trials (0.5%; n=190). In postmarketing experience, a case of fatal anaphylaxis following the first infusion of ORENCIA was reported. Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use. If an anaphylactic or other serious allergic reaction occurs, administration of ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.
Infections: Serious infections, including sepsis and pneumonia, have been reported in patients receiving ORENCIA. Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which, in addition to their underlying disease, could further predispose them to infection. Caution should be exercised in patients with a history of infection or underlying conditions which may predispose them to infections. Treatment with ORENCIA should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis and viral hepatitis in accordance with published guidelines, and if positive, treated according to standard medical practice prior to therapy with ORENCIA.
Immunizations: Live vaccines should not be given concurrently with ORENCIA or within 3 months of its discontinuation. The efficacy of vaccination in patients receiving ORENCIA is not known. ORENCIA may blunt the effectiveness of some immunizations. It is recommended that JIA patients be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating therapy with ORENCIA.
Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): Adult COPD patients treated with ORENCIA developed adverse events more frequently than those treated with placebo, including COPD exacerbations, cough, rhonchi, and dyspnea. In adult RA studies, 97% of COPD patients treated with ORENCIA developed adverse reactions versus 88% treated with placebo and respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43% vs 24%, respectively), including COPD exacerbation, cough, rhonchi, and dyspnea. A greater percentage of adult RA patients treated with ORENCIA developed a serious adverse event compared to those on placebo (27% vs 6%), including COPD exacerbation [3 of 37 patients (8%)] and pneumonia [1 of 37 patients (3%)]. Use of ORENCIA in patients with RA and COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.
Blood Glucose Testing: ORENCIA for intravenous administration contains maltose, which may result in falsely elevated blood glucose readings on the day of infusion when using blood glucose monitors with test strips utilizing glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ). Consider using monitors and advising patients to use monitors that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase or glucose hexokinase test methods. ORENCIA for subcutaneous (SC) administration does not contain maltose; therefore, patients do not need to alter their glucose monitoring.
Pregnancy: There are no adequate and well-controlled studies of ORENCIA use in pregnant women and the data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. A pregnancy registry has been established to monitor pregnancy outcomes in women exposed to ORENCIA during pregnancy. Healthcare professionals are encouraged to register patients by calling 1-877-311-8972.
Lactation: There is no information regarding the presence of abatacept in human milk, the effects on the breastfed infant, or the effects on milk production. However, abatacept was present in the milk of lactating rats dosed with abatacept.
Most Serious Adverse Reactions: Serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo).
Malignancies: The overall frequency of malignancies was similar between adult RA patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in RA patients treated with ORENCIA (0.2%) than those on placebo (0%). A higher rate of lymphoma was seen compared to the general population; however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of ORENCIA in the development of malignancies in humans is unknown.
Most Frequent Adverse Events (≥10%): Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events in the adult RA clinical studies. Other events reported in ≥5% of JIA patients were diarrhea, cough, pyrexia, and abdominal pain. In general, the adverse events in JIA and adult PsA patients were similar in frequency and type to those seen in adult RA patients.
Note concerning ORENCIA administration options: Intravenous dosing has not been studied in patients younger than 6 years of age. The safety and efficacy of ORENCIA ClickJect™ Autoinjector for subcutaneous injection has not been studied in patients under 18 years of age.
Please click here to see the Full Prescribing Information.
About Bristol-Myers Squibb Immunoscience
With a robust pipeline of immunomodulatory therapies, Bristol-Myers Squibb is committed to the discovery and development of transformational medicines for patients suffering from immune-mediated disease. As we learn more about the immune system in diseases with substantial unmet medical needs, the potential for new therapies that modulate the immune system continues to drive our research efforts.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2016 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
References
1. ORENCIA® Prescribing Information. Bristol-Myers Squibb Company, Princeton, NJ. June 2017.
2.
Psoriatic Arthritis. American College of Rheumatology. https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis. Accessed May 8, 2017.
3.
Psoriatic Arthritis Overview. National Institutes of Health. https://www.niams.nih.gov/Health_info/Psoriatic_Arthritis/default.asp. Accessed May 8, 2017.
4.
Mease P., Gottlieb A., Heijde H., et al. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase 3 study in psoriatic arthritis. Annals of the Rheumatic Diseases. 2017
5.
About Psoriatic Arthritis. National Psoriasis Foundation. https://www.psoriasis.org/about-psoriatic-arthritis. Accessed June 21, 2017.
6.
What is Psoriatic Arthritis? The Arthritis Foundation. http://www.arthritis.org/about-arthritis/types/psoriatic-arthritis/what-is-psoriatic-arthritis.php. Accessed May 8, 2017.
7.
Gladman D, Antoni C, Mease P., et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Annals of the Rheumatic Diseases. 2005
8. Mease P, Genovese MC, Gladstein G. Abatacept in the treatment of patients with psoriatic arthritis: Results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial. Arthritis & Rheumatism. 2011;63(4):939-948.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170706005249/en/
Bristol-Myers Squibb Company
Media:
Erin McMaster, 609-955-2253
erin.mcmaster@bms.com
or
Investors:
Bill Szablewski, 609-252-5894
william.szablewski@bms.com
_______________________________________________
BMY
Bristol-Myers’ tarnished checkpoint star Opdivo beats out Yervoy in surprise PhIII
by john carroll — on July 5, 2017 09:47 AM EDT
Updated: 01:24 PM
Bristol-Myers got a much-needed boost with the earlier-than-expected news that Opdivo beat out Yervoy in a Phase III study focused on a particular niche for adjuvant melanoma therapy. And an analyst who’s been following the data says it could be worth a billion dollars in added annual sales.
The big biotech says an interim analysis of Checkmate-238 provided researchers with proof that the PD-1 drug outperformed Yervoy, Bristol-Myers’ CTLA-4 drug, among advanced Stage IIIb or IV patients, cutting the recurrence rate for those who have undergone surgery. There are no bottom line numbers in the statement, but Bristol-Myers says they’ll be able to release data at an upcoming conference to show that Opdivo provided a significantly lower risk of disease recurrence.
Seamus Fernandez notes that the results are likely to cannibalize Bristol’s Yervoy revenue, but will likely deliver a $1 billion boost to Opdivo as physicians steer away from the higher doses of highly toxic Yervoy. He noted:
This comes as a surprise, as top-line data were not expected until the final readout in 2H:18. While there were no details in the press release regarding the magnitude of benefit for Opdivo, we would expect it to become the standard of care in high-risk patients following surgical resection given its superior safety and tolerability profile relative to Yervoy. We estimate the adjuvant melanoma market will expand PD1 sales by approximately $3B globally. Although this likely will cannibalize sales of Yervoy in the setting (we estimate current adjuvant Yervoy sales at $300-400M), the expansion of the market should add approximately $1B to BMY’s net immuno-oncology (IO) sales despite assumed competition from MRK’s (MP) Keytruda (pembrolizumab; anti-PD-1).
Vicki Goodman
Opdivo’s rocky road at Bristol has led to endless speculation that the company could find itself on the auction block before it gets a chance to reorganize in the clinic and come back in its head-to-head showdown with Merck’s Keytruda. But it is also racking up billions in annual sales of Opdivo, with a slate of new trials underway.
“These topline results support the potential promise of Opdivo as a treatment option for patients with high-risk surgically resected melanoma. There remains an unmet need for additional options as the majority of stage III and resected stage IV high-risk melanoma patients experience disease recurrence after surgery,” said Vicki Goodman, development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb. “We are committed to researching therapies that may better meet the needs of this patient population and look forward to sharing these data with health authorities soon.”
Jeffrey Weber
Physicians in the field, including the high profile Jeffrey Weber at NYU Langone, have been waiting to see how this one will shake out. And they’re getting the readout a year ahead of schedule. In a panel chat with experts in the field in the spring of 2016, he noted:
On the basis of my own experience with both drugs in pilot adjuvant trials, I have a suspicion that nivolumab is going to look better than ipilimumab. And the next frontier is what we’ve already piloted when I was at Moffitt and we’ll continue at NYU, which is combination adjuvant therapy. But because of the toxicity, we flipped the doses giving one of ipilimumab and three of nivolumab, which is very well-tolerated with a pretty good track record, admittedly, in a small study. So, I think that we’ve gone from interferon, we’ll go to ipilimumab, we’ll go to nivolumab, and eventually end up at ipilimumab plus nivolumab, over the next five years, which brings us to where we’re going in metastatic treatment. I think we’re going to see triple combinations. On the one hand, it’s scientifically fascinating, extremely complex with paradoxically a bar that’s now so high, it’s going to be very difficult to get combinations approved. You’re going to need to see major incremental advantages, which I think you probably will see with some of the drugs my colleagues have mentioned. But they’re also going to be very expensive, so pharmacoeconomics is also going to play a huge role in what we do. Right now, I would estimate that the cost of ipilimumab plus nivolumab therapy for a year is about $250,000. So, I would ask where does this all end?
https://endpts.com/bristol-myers-tarnished-checkpoint-star-opdivo-beats-out-yervoy-in-surprise-phiii/?utm_medium=email&utm_campaign=257%20Wednesday%207517%20Surprise%20PhIII%20success%20bolsters%20Bristol-Myers%20Opdivo%20plans%20Judge%20tells%20Shkreli%20to%20zip%20it%20as%20Twitter%20clamps%20down%20-%20again&utm_content=257%20Wednesday%207517%20Surprise%20PhIII%20success%20bolsters%20Bristol-Myers%20Opdivo%20plans%20Judge%20tells%20Shkreli%20to%20zip%20it%20as%20Twitter%20clamps%20down%20-%20again+CID_50858b30d4f444f687fe9368c425236b&utm_source=ENDPOINTS%20emails&utm_term=Bristol-Myers%20tarnished%20checkpoint%20star%20Opdivo%20beats%20out%20Yervoy%20in%20surprise%20PhIII
BMY
It sure seems that PFE is the most frequently mentioned purchaser and as a a holder would be just fine with 30%. It was overbought back when it was $75/76.
Current consensus is only ~10%
Consensus Ratings for Bristol-Myers Squibb Company (NYSE:BMY) (How are Consensus Ratings Calculated?)
Ratings Breakdown: 1 Sell Rating, 10 Hold Ratings, 10 Buy Ratings
Consensus Rating: Hold (Score: 2.43)
Consensus Price Target: $62.35 (10.81% upside)
https://www.marketbeat.com/stocks/NYSE/BMY/
Recall the Barrons article this past weekend:
"Bristol-Myers Could Return 40% in Two to Three Years" by Vito J. Racanelli points out that Bristol-Myers Squibb Co (NYSE: BMY) may not be a high-flying tech stock, but it is a leader in high-tech cancer treatments. Though the drugmaker has taken a beating after a disappointing lung-cancer trial and a related setback involving its Opdivo, see how patient investors could be rewarded"
BMY
Bristol-Myers goes ex-dividend on Wed (July 5th)
http://www.nasdaq.com/article/ex-dividend-reminder-bristol-myers-squibb-medtronic-and-global-net-lease-cm811191
BMY
Presumed source probably was CNA Finance, but their article was merely a tease. I suppose it was a good day for a rumor with the company buying back those shares.
BMY
Source of rumor alluded to by SA:
Bristol-Myers Squibb (BMY) Stock: Spiking On Rumor Of PFE Takeover
InvestingBiotechBreaking NewsJun 21, 2017 0 185
Bristol-Myers Squibb Co (NYSE: BMY) is is experiencing a relatively strong spike in the market at the moment, and for good reason. There are rumors surfacing that the company will soon be taken over. Of course, these rumors are leading to excitement among investors, sending the stock upward. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (10:45), BMY is trading at $55.88 per share after a gain of $0.22 per share or 0.40% thus far today.
Rumors Suggest That PFE May Buy BMY
As mentioned above, the spike that BMY is seeing in the market at the moment has to do with the idea that the company will soon be taken over. Currently, rumors are breaking all over the social space that Pfizer Inc. (NYSE: PFE) is interested in taking the company over. However, there is no indication at what price, nor confirmation from either side at the moment.
Nonetheless, it's important to remember that rumors like this are common in the market. In fact, there was a rumor just a few months ago that PFE was interested in taking BMY over, but the rumor never came to fruition. With that said, it is unlikely that this takeover is going to happen. So, if you're going to trade on this news, please do so with caution.
Stop wasting your time! Find winning trades in minutes with Trade Ideas!
What We'll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on both BMY and PFE. In particular, we're interested in following the story surrounding the potential takeover. While it is unlikely that the rumor is correct, if it is, the takeover would likely generate an incredible return of value for investors. Nonetheless, we'll continue to follow the story closely and bring the news to you as it breaks!
Never Miss The News Again
Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!
______________________________________________________
https://cnafinance.com/bristol-myers-squibb-bmy-stock-spiking-on-rumor-of-pfe-takeover/15736
BMY
Takeover rumors de jour: Pfizer taking out Bristol-Myers, ACADIA Pharma
Jun. 21, 2017 11:08 AM ET|About: ACADIA Pharmaceuticals... (ACAD)|By: Douglas W. House, SA News Editor
For investors who enjoy the rumor mill: Pfizer (PFE +1%) is mulling a takeout of Bristol-Myers Squibb (BMY +0.2%) and ACADIA Pharmaceuticals (ACAD +3.4%) is in the crosshairs of an unnamed suitor.
_________________________________________________
https://seekingalpha.com/news/3274801-takeover-rumors-de-jour-pfizer-taking-bristol-myers-acadia-pharma?app=1&uprof=46#email_link
BMY
Out CYBR @ $49.98. Will buy back, but was longer than intended with a couple of additional buys. Can't believe that this (or HACK or CIBR) isn't good long term.
CYBR
Companies Get New Suit Limits as Supreme Court Backs Bristol-Myers
by Greg Stohr
June 19, 2017, 10:12 AM EDT June 19, 2017, 11:28 AM EDT
Court says non-Californians can’t join Bristol-Myers suit
Alito says plaintiffs can sue as group in other states
The U.S. Supreme Court gave companies a new tool to defeat some legal claims, siding with Bristol-Myers Squibb Co. in a bid to limit a consumer lawsuit in California over its Plavix blood thinner.
The justices, voting 8-1, said the California Supreme Court was wrong to let almost 600 non-Californians join 86 state residents in claiming Bristol-Myers misrepresented the risk of heart attacks and strokes.
The case tested the constitutional power of state courts to adjudicate suits by non-residents when the alleged wrongdoing occurred elsewhere.
The majority said the out-of-state plaintiffs hadn’t shown enough of a connection between their alleged injuries and the company’s activities in California.
The out-of-state people argued it made sense for their cases to go forward in California because the courts there were already considering identical claims by state residents.
Writing for the court, Justice Samuel Alito said the plaintiffs could sue Bristol-Myers together in other states, including New York, where the company has its headquarters, and Delaware, where it is incorporated.
The ruling "will not result in the parade of horribles that respondents conjure up," Alito wrote, referring to the plaintiffs.
In dissent, Justice Sonia Sotomayor said the ruling "may make it impossible to bring certain mass actions at all."
The case is Bristol-Myers Squibb v. Superior Court, 16-466.
________________________________________________
https://www.bloomberg.com/politics/articles/2017-06-19/companies-get-new-suit-limits-as-high-court-backs-bristol-myers
BMY
Back in LBY @ $8.16. Got to go back up in a few days.
LBY
Motley Fool article:
Is the Market Wrong About Bristol-Myers Squibb?
There's a lot of negativity about Bristol-Myers Squibb's prospects. Is it too negative?
Keith Speights (TMFFishBiz) Jun 15, 2017 at 3:21PM
Bristol-Myers Squibb (BMS) (NYSE:BMY) might be the pharmaceutical company equivalent of the late comedian Rodney Dangerfield. Dangerfield's money-line during his career was, "I don't get no respect." BMS executives and shareholders could be saying the same thing these days. The stock is down nearly 30% after disappointing clinical study results for cancer drug Opdivo were announced in August 2016.
The drugmaker's chief scientific officer, Thomas Lynch, got a taste of the negativity associated with Bristol-Myers Squibb when he answered questions at the Goldman Sachs Healthcare Conference on Wednesday. Lynch seemed to be on the defensive during most of the session, with plenty of skeptical questions about the prospects for Opdivo. His responses, though, prompted a question in my mind: Is the market possibly wrong about Bristol-Myers Squibb?
Arrow sign post with mistake
IMAGE SOURCE: GETTY IMAGES.
Reading too much into Checkmate-012 results?
Lynch was asked about the negative reaction by investors to Bristol-Myers Squibb's update on its Checkmate-012 study of Opdivo combined with Yervoy at the American Society of Clinical Oncology (ASCO) meeting earlier this month. The updated two-year survival data from this study showed the overall survival rate fell off dramatically for patients with 50% or greater PD-L1 expression after two years, compared to after one year.
He pointed out two important things to note about the Checkmate-012 study results. First, there were 12 patients with those high levels of PD-L1 expression taking Opdivo only, and 13 patients over-expressing PD-L1 taking the Opdivo/Yervoy combination. That's a very low sample size upon which to base any conclusions.
Second, Lynch noted strong progression-free survival (PFS) rates. He also discussed why PFS is more closely related to the activity of the drug(s) being taken. In fact, Merck (NYSE:MRK) won approval for Keytruda as a first-line treatment of lung cancer based on clinical data that showed only PFS improvement, and not OS improvement.
Are some investors reading too much into the Checkmate-012 results? I think so.
Too pessimistic about Checkmate-227?
Bristol-Myers Squibb expects to report initial results from its Checkmate-227 study by early 2018. This study is evaluating Opdivo in combination with chemotherapy in treating non-small cell lung cancer (NSCLC). A comment was made at the conference on Wednesday that investors don't feel as confident about the study after the Checkmate-012 results.
Lynch stressed that findings from the 012 study simply can't be used to predict what might happen in the 227 study. And he's right.
Lynch is also correct to caution against reading too much into how its 227 study could fare based upon results from AstraZeneca's (NYSE:AZN) late-stage MYSTIC study of Imfinzi (durvalumab) as a monotherapy, and in combination with tremelimumab in treating first-line NSCLC. AstraZeneca should announce those results within the next few weeks.
I also think that Lynch answered wisely when asked if investors were underestimating the opportunity for Opdivo as a monotherapy in treating first-line NSCLC. He noted that the 227 study includes an arm evaluating the drug as a stand-alone treatment and added, "We'll see where that takes us."
The bottom line is that Checkmate-227 stands on its own. Too much pessimism (or optimism, for that matter) is premature at this stage.
Forgetting there's more than just Opdivo?
Lynch did have an opportunity to discuss Bristol-Myers Squibb's pipeline beyond Opdivo, which he described as "incredibly rich." He especially noted the potential for the company's experimental anti-LAG3 and IDO-inhibitor cancer drugs.
But Lynch also reiterated something that BMS CEO Giovanni Caforio said not long ago, "We're not just a cancer company." While he didn't talk much about Bristol-Myers Squibb's products outside of oncology, sales for anticoagulant Eliquis are booming and rheumatoid arthritis drug Orencia is also doing well.
My take is that the market is focused nearly exclusively on possible negatives for Opdivo. I suspect that many are basing their view of BMS' prospects on a "reading of tea leaves" that could turn out to be flat wrong. It could very well turn out that Bristol-Myers Squibb isn't in nearly as bad of a position as some seem to think it is.
Keith Speights has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
________________________________________________________
https://www.fool.com/investing/2017/06/15/is-the-market-wrong-about-bristol-myers-squibb.aspx
BMY
Out LBY @ $8.55. Took advantage of the early run. Of late has been a good several day trade. Typically shoots up early on low volume due to wide bid/ask spread and generally drifts down throughout the day.
LBY