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Strange trade, cancelled and made again:
08:40:05 $ 52.57 High 172,128
08:30:17 $ 52.57 172,128 - Cancelled Trade
08:00:02 $ 52.57 172,128
http://www.nasdaq.com/g00/symbol/bmy/premarket
BMY
Big trade pm:
08:00:02 $ 52.57 High 172,128 ($9,048,663.80) -- always a buyer and seller.
BMY0
Out @ $25.35. Great earnings and surprise. Back in at the next dip.
GIII
Back in LBY @ $8.10. Took 7 separate trades for the MM to get the shares -- hard to come by suggest near bottom?
LBY announced huge share buy-back program over the weekend.
LBY
BMY ASCO2017 Investor Event:
https://s21.q4cdn.com/104148044/files/doc_presentations/2017/ASCO-INVESTOR-DECK-final.pdf
BMY
Bristol-Myers' Opdivo/Yervoy combo shows positive effect in metastatic melanoma to the brain, but with significant side effects including three deaths; shares ease 2% premarket
Jun. 5, 2017 9:17 AM ET|About: Bristol-Myers Squibb C... (BMY)|By: Douglas W. House, SA News Editor
Despite a plethora of positive trial data presented at ASCO, Bristol-Myers Squibb (NYSE:BMY) is under early pressure in apparent response to results from a mid-stage study, CheckMate-204, assessing the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) in patients with melanoma that has metastasized in the brain.
The overall response rate was impressive, 55%, including 21% complete responders, but grade 3 (serious) and grade 4 (life-threatening) side effects occurred in 52% (n=39) of participants. Six (8%) were neurologic, including headaches. Three treatment-related deaths were reported (cardiogenic shock, intracranial hemorrhage and malignant neoplasm progression).
#ASCO17
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https://seekingalpha.com/news/3271549-bristol-myers-opdivo-yervoy-combo-shows-positive-effect-metastatic-melanoma-brain-significant?app=1&uprof=46#email_link
BMY
A LAG-3, Opdivo combo from Bristol-Myers offers a proof-of-concept glimpse of limited success
by john carroll — on June 3, 2017 11:57 AM EDT
Updated: June 5, 2017 05:41 AM
chicago — Now that the first wave of PD-(L)1 drugs has splashed out and is getting established in the cancer market, one of the next steps down the pipeline involves matching up checkpoint inhibitors in new combos as the leaders in the field pursue a fast and furious R&D strategy to market expansion. To that end, Bristol-Myers Squibb $BMY turned up at ASCO with some intriguing proof-of-concept data that marries their drug Opdivo with a LAG-3 drug, offering an early glimpse on how it could work for a particular category of patient.
Paolo Ascierto
Their combo, BMS-986016, achieved a 12.5% objective response rate among 55 melanoma patients who had already been on a PD-(L)1 therapy. More importantly, there was significant split in responses among patients based on LAG-3 expression, with 20% of the patients with at least 1% of tumor-associated immune cells within the tumor margin achieving an ORR compared to 7.1% with less than 1%.
Jefferies’ Biren Amin concluded that the data were underwhelming, but an adjustment around LAG-3 expression could enhance its future.
Opdivo was the first of the PD-(L)1s to dominate the market, but after Bristol-Myers’ trial work derailed on a misstep in lung cancer, the big biotech has doubled down on oncology, shaking up its R&D group and tackling a steadily widening number of studies. This is one step back in the right direction.
“As a potentially synergistic immune pathway to PD-1/PD-L1, LAG-3 has emerged as an immune checkpoint receptor that regulates T cell function and whose inhibition may increase benefits for patients,” said Paolo Ascierto of the Istituto Nazionale Tumori Fondazione Pascale of Naples, Italy. “These results indicate that BMS-986016 in combination with Opdivo may offer clinical benefit, particularly for patients whose tumors contain immune cells that express LAG-3. Further investigation is warranted to understand the impact of this combination as well as the utility of LAG-3 as an immune biomarker.”
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https://endpts.com/a-lag-3-opdivo-combo-from-bristol-myers-offers-a-proof-of-concept-glimpse-of-success/?utm_medium=email&utm_campaign=236%20ASCO%20Special&utm_content=236%20ASCO%20Special+CID_12d6e3d9298032a4664720f9f4fd2257&utm_source=ENDPOINTS%20emails&utm_term=A%20LAG-3%20Opdivo%20combo%20from%20Bristol-Myers%20offers%20a%20proof-of-concept%20glimpse%20of%20limited%20success
BMY
Hope so -- soon. But down ~ 2.4% pre-market. News, not technicals. Not sure what in particular is guiding the trading since they had a lot of news over the weekend. Any ideas?
Still a lot of ASCO presentations to go.
BMY
Merck reports positive results for late-stage trial comparing its Keytruda against Bristol-Myers' Yervoy
Published: June 2, 2017 7:49 a.m. ET
Merck & Co. Inc. MRK, +0.23% said premarket Friday that a late-stage clinical trial comparing its cancer drug Keytruda to Bristol-Myers Squibb's [: BMY] cancer drug Yervoy found patients on Keytruda had better results. The trial, which enrolled 834 patients with unresectable or metastatic melanoma who were either new to treatment or had received one prior treatment, found that treatment with Keytruda was associated with a 30% improvement in survival. About half of patients on Keytruda remained alive nearly three years after starting the therapy, the company said, compared with 39% of patients on Yervoy. The company also reported that Keytruda nearly doubled the progression-free survival rate at nearly three years, with 31% of patients on Keytruda surviving without disease progression, compared to 14% of patients on Yervoy. The results are scheduled to be presented at the American Society of Clinical Oncology meeting on Sunday. Merck shares were not active in premarket trade. Shares have declined 1.2% over the last three months, compared with a 4.1% decline in Bristol-Myers shares and a 2% rise in the S&P 500 SPX, +0.76%
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http://www.marketwatch.com/story/merck-reports-positive-results-for-late-stage-trial-comparing-its-keytruda-against-bristol-myers-yervoy-2017-06-02
BMY
Bristol-Myers and Seattle Genetics advance Opdivo/Adcetris combo for HL into Phase 3
Jun. 2, 2017 7:07 AM ET|About: Bristol-Myers Squibb C... (BMY)|By: Douglas W. House, SA News Editor
Motivated by encouraging results in a Phase 1/2 study, Bristol-Myers Squibb (NYSE:BMY) and Seattle Genetics (NASDAQ:SGEN) have entered into a collaboration agreement to assess the combination of Opdivo (nivolumab) and ADCETRIS (brentuximab vedotin) in a Phase 3 clinical trial in patients with relapsed/refractory or stem cell transplant-ineligible advanced classical Hodgkin lymphoma (HL).
The late-stage open-label study should commence in the next month or two.
Opdivo is a PD-1 immune checkpoint inhibitor. ADCETRIS is an antibody-drug conjugate (ADC) consisting of a CD30-targeting monoclonal antibody attached to a cytotoxic agent called monomethyl auristatin E.
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https://seekingalpha.com/news/3271235-bristol-myers-seattle-genetics-advance-opdivo-adcetris-combo-hl-phase-3?app=1&uprof=46#email_link
BMY
Out @ $8.48 for a little profit and the dividend. Surprised it has gone higher after the sale because of late has rarely surpassed the early day high. Several times had the high ask but MM didn't sell it.
Looking to get back in -- lot of room above.
LBY
Back in old favorite @ $19.80.
GIII
Impossible to decipher this stock. Yesterday by all rights should have been up but was down. Today when no reason to be up except approaching ASCO (and ~ 200K buy at about 2:30) it is up.
BMY
Back in LBY @ $8.15. Goes ex- tomorrow:
______________________________________________________
Libbey, Inc. (LBY) Ex-Dividend Date Scheduled for May 26, 2017
May 25, 2017, 09:00:02 AM EDT By NASDAQ.com News
Shutterstock photo
Libbey, Inc. ( LBY ) will begin trading ex-dividend on May 26, 2017. A cash dividend payment of $0.117 per share is scheduled to be paid on June 14, 2017. Shareholders who purchased LBY prior to the ex-dividend date are eligible for the cash dividend payment. This represents an -0.43% decrease from the prior dividend payment. At the current stock price of $8.3, the dividend yield is 5.66%.
The previous trading day's last sale of LBY was $8.3, representing a -60.02% decrease from the 52 week high of $20.76 and a 4.8% increase over the 52 week low of $7.92.
LBY is a part of the Capital Goods sector, which includes companies such as Thermo Fisher Scientific Inc ( TMO ) and Danaher Corporation ( DHR ). LBY's current earnings per share, an indicator of a company's profitability, is $.13.
For more information on the declaration, record and payment dates, visit the LBY Dividend History page. Our Dividend Calendar has the full list of stocks that have an ex-dividend today.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
_______________________________________________
LBY
I generally don't comment much when I'm out of a stock, but you seem to be correct. I see Barron's blog called them out on this upgrade.
X
U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Previously Treated Hepatocellular Carcinoma
MAY 24, 2017
Application is based on results from the Phase 1/2 CheckMate -040 trial
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 hepatocellular carcinoma (HCC) after prior sorafenib therapy. The FDA granted the application priority review and previously granted Opdivo orphan-drug designation for the treatment of HCC. The FDA action date is September 24, 2017.
“We believe the FDA acceptance of our application for Opdivo with priority review status is an important recognition of the significant unmet need for patients with HCC, which is often diagnosed in the advanced stage when treatment options are limited,” said Ian M. Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol-Myers Squibb. “We are committed to exploring new treatment options for these patients and look forward to working with the FDA to potentially extend the use of Opdivo as a treatment option in this setting.”
The submission was based on data from the Phase 1/2 CheckMate -040 study investigating Opdivo in advanced HCC patients with and without hepatitis B virus or hepatitis C virus infections. Data from this study were recently published in The Lancet and will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2017 during a poster discussion session on June 3, 2017 from 4:45–6:00 PM CDT in Hall D2.
About Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the most common type of liver cancer and the second most frequent cause of cancer death worldwide. More than 700,000 people around the world, including about 40,000 people in the United States, are diagnosed with HCC each year. The majority of these cases are caused by hepatitis B virus (HBV) or hepatitis C virus (HCV) infections, making HBV/HCV the most common risk factors for liver cancer.
HCC is often diagnosed in the advanced stage where treatment options are limited and outcomes are poor, with one-year survival rates in the advanced setting of approximately 44%. For patients who are intolerant to or who have progressed during sorafenib therapy, median survival remains less than 11 months with currently available treatment options.
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 35 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 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 patients’ individual 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 Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials 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. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
U.S. FDA-APPROVED INDICATIONS FOR OPDIVO®
OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor 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
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
YERVOY 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.
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. In patients receiving OPDIVO with YERVOY, immune-mediated pneumonitis occurred in 6% (25/407) of patients.
In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=12).
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. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) patients. Across all YERVOY-treated patients in that study (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis.
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. In patients receiving OPDIVO with YERVOY, immune-mediated hepatitis occurred in 13% (51/407) of patients.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3-5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%.
Immune-Mediated Neuropathies
In a separate Phase 3 study of YERVOY 3 mg/kg, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported.
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 with YERVOY, hypophysitis occurred in 9% (36/407) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In patients receiving OPDIVO with YERVOY, adrenal insufficiency occurred in 5% (21/407) 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 with YERVOY, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving OPDIVO with YERVOY. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In patients receiving OPDIVO with YERVOY, diabetes occurred in 1.5% (6/407) of patients.
In a separate Phase 3 study of YERVOY 3 mg/kg, 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 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. 6 of the 9 patients were hospitalized for severe endocrinopathies.
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. In patients receiving OPDIVO with YERVOY, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients.
Immune-Mediated Skin Adverse Reactions and Dermatitis
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. In patients receiving OPDIVO with YERVOY, immune-mediated rash occurred in 22.6% (92/407) of patients.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal immune-mediated dermatitis (eg, 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 (2.5%) patients. 1 (0.2%) patient died as a result of toxic epidermal necrolysis. 1 additional patient required hospitalization for severe dermatitis.
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. Encephalitis occurred in one patient receiving OPDIVO with YERVOY (0.2%) after 1.7 months of exposure.
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. In patients receiving OPDIVO with YERVOY, infusion-related reactions occurred in 2.5% (10/407) of patients.
Complications of Allogeneic HSCT after OPDIVO
Complications, including fatal events, occurred in patients who received allogeneic HSCT after OPDIVO. Outcomes were evaluated in 17 patients from Checkmate 205 and 039, who underwent allogeneic HSCT after discontinuing OPDIVO (15 with reduced-intensity conditioning, 2 with myeloablative conditioning). Thirty-five percent (6/17) of patients died from complications of allogeneic HSCT after OPDIVO. Five deaths occurred in the setting of severe or refractory GVHD. Grade 3 or higher acute GVHD was reported in 29% (5/17) of patients. Hyperacute GVHD was reported in 20% (n=2) of patients. A steroid-requiring febrile syndrome, without an identified infectious cause, was reported in 35% (n=6) of patients. Two cases of encephalitis were reported: Grade 3 (n=1) lymphocytic encephalitis without an identified infectious cause, and Grade 3 (n=1) suspected viral encephalitis. Hepatic veno-occlusive disease (VOD) occurred in one patient, who received reduced-intensity conditioned allogeneic HSCT and died of GVHD and multi-organ failure. Other cases of hepatic VOD after reduced-intensity conditioned allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptor blocking antibody before transplantation. Cases of fatal hyperacute GVHD have also been reported. These complications may occur despite intervening therapy between PD-1 blockade and allogeneic HSCT.
Follow patients closely for early evidence of transplant-related complications such as hyperacute GVHD, severe (Grade 3 to 4) acute GVHD, steroid-requiring febrile syndrome, hepatic VOD, and other immune-mediated adverse reactions, and intervene promptly.
Embryo-Fetal Toxicity
Based on their mechanisms of action, OPDIVO and YERVOY 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- or YERVOY- containing regimen and for at least 5 months after the last dose of OPDIVO.
Lactation
It is not known whether OPDIVO or YERVOY 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. Advise women to discontinue nursing during treatment with YERVOY and for 3 months following the final dose.
Serious Adverse Reactions
In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO . The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (73% and 37%), adverse reactions leading to permanent discontinuation (43% and 14%) or to dosing delays (55% and 28%), and Grade 3 or 4 adverse reactions (72% and 44%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.6%), colitis (10% and 1.6%), and pyrexia (10% and 0.6%). In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in ≥1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last OPDIVO dose, 2 from infection 8 to 9 months after completing OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO. The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration.
Common Adverse Reactions
In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (59%), rash (53%), diarrhea (52%), nausea (40%), pyrexia (37%), vomiting (28%), and dyspnea (20%). The most common (≥20%) adverse reactions in the OPDIVO (n=313) arm were fatigue (53%), rash (40%), diarrhea (31%), and nausea (28%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were asthenic conditions (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 205 and 039, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=266) were upper respiratory tract infection (44%), fatigue (39%), cough (36%), diarrhea (33%), pyrexia (29%), musculoskeletal pain (26%), rash (24%), nausea (20%) and pruritus (20%). In Checkmate 141, the most common adverse reactions (≥10%) in patients receiving OPDIVO were cough and dyspnea at a higher incidence than investigator’s choice. In Checkmate 275, the most common adverse reactions (≥ 20%) reported in patients receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%).
In a separate Phase 3 study of YERVOY 3 mg/kg, 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%).
Checkmate Trials and Patient Populations
Checkmate 067 - advanced melanoma alone or in combination with YERVOY; Checkmate 037 and 066 - advanced melanoma; Checkmate 017 - squamous non-small cell lung cancer (NSCLC); Checkmate 057 - non-squamous NSCLC; Checkmate 025 - renal cell carcinoma; Checkmate 205/039 - classical Hodgkin lymphoma; Checkmate 141 - squamous cell carcinoma of the head and neck; Checkmate 275 - urothelial carcinoma.
Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY.
About the Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Ltd (Ono), 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 23, 2014, Bristol-Myers Squibb and Ono 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. Among other risks, there can be no guarantee that Opdivo will receive regulatory approval for an additional indication. 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170524005865/en/
Source: Bristol-Myers Squibb Company
Hope it goes higher. I could have done a lot better as my original ask set pre-market was $20.60. What fooled me is that this will probably be the largest daily % gain in a year. I had checked the chart and that appeared to be the case. I see that aside from the post election run it also had a nice run from the end of last June through the beginning of August -- so what you say could happen again. Good luck!
X
Out X for now @ $20.35. Too little faith as it kept going up after, but was afraid it wouldn't match again the HOD of $20.44.
Going to revisit later.
X
Think SA found the reason for the surge today:
___________________________________________________________
Steel stocks on the move ahead of U.S. Section 232 hearing
May 23, 2017 12:41 PM ET|By: Carl Surran, SA News Editor
Steel stocks (SLX +1.4%) surge to session highs ahead of tomorrow's Commerce Department public hearing on its Section 232 investigation into the impact of steel imports on U.S. national security.
Macquarie says the Trump administration’s focus on Section 232 trade action could reduce supply further and a widespread action could meaningfully affect supply.
Jefferies says while the probability is high for some incremental trade defense measures, the scope of the investigation remains a key unknown and the hearing may provide color on various considerations at play.
Steel names are broadly higher: AKS +7.4%, X +4.4%, RS +4.1%, STLD +3.4%, NUE +3%, CMC +3%, WOR +2%, CLF +1.9%, MT +0.3%.
Source: Bloomberg First Word
_____________________________________________________
X
Good call. See no news re: X. Whole sector has moved higher (SLX up ~2%).
X
Out of LBY for now @ $9.25. Took profits. Will see about re-entering for dividend.
LBY
Nice reversal @ 10:00. Can't find a reason nor news, but hope it holds $20.00 through the EOD.
X
Bristol-Myers Squibb (BMY) Management Presents at UBS Global Healthcare Conference 2017 - Brokers Conference Transcript
May 22, 2017 1:02 PM ET|1 comment| About: Bristol-Myers Squibb Company (BMY)
Bristol-Myers Squibb Company (NYSE:BMY)
Company Conference Presentation
May 22, 2017, 10:00 AM ET
Executives
Murdo Gordon - Chief Commercial Officer
Analysts
Marc Goodman - UBS Securities LLC
Operator
Marc Goodman
All right, we're going to get started with our next session and from Bristol-Myers we have Murdo Gordon. Thank you very much for joining us. I know you've joined us after quite a long time ago. I looked it up, it was 1989, so you are a Bristol lifer, but importantly you became Chief Commercial Officer about a year ago.
So obviously the world has changed dramatically and I think, so maybe we could focus on commercial, we can start with Opdivo. I think everyone was surprised that U.S. sales were actually up versus fourth quarter. Maybe you can talk about how you did that and how you have done such a good job maintaining the share and gaining the share in different areas. Give a little sense of what's been going on with Opdivo?
Murdo Gordon
Sure thanks for having me here Marc. Yes in 1989 the difference was my hair was a little bigger, the bags under the eyes were different, but it's been really exciting and particularly since becoming the Chief Commercial Officer where the company has really had significant challenges that also we continue to feel really good about the opportunities that exist in the marketplace and I think the first quarter was a good indicator of that.
The commercial organization broadly in the U.S. as well as ex-U.S. has been able to execute really well in the oncology portfolio, but also outside of the oncology portfolio with performances on Eliquis also doing extremely well. In particular in the U.S. with I-O we were very pleased to see the shares holding in second line on cancer. The Opdivo shares are running 40% and really flat and that was a really important thing for us to see.
Outside of lung cancer in the U.S. we continue to grow nicely in our core tumor types. We've seen a good build in melanoma. We've got really strong performance in second line share in renal cell carcinoma and emerging trends look good in head and neck, bladder and some of the smaller indications. So overall in the U.S. the growth is largely outside of lung cancer and overall worldwide we've got really good trends that have emerged since securing reimbursement in countries like France, Germany, Japan, Canada more recently, and Italy and Spain more recently.
Marc Goodman
So just a focus on the U.S. one second and then obviously Merck has a new approval, so give us a sense of how you expect the landscape to change over the next quarter or two?
Murdo Gordon
Sure, the Merck approval is something that we largely expected and built into our assumptions going forward. So I think the first line approval and as the chemotherapy combination approval in non-squamous, non-small cell lung cancer is largely in line with what we had expected. And I think even with that the performance in 2017 should continue fairly well in terms of the second line share, that pool of second line patients we think a little, but the larger impact of the first line usage of I-O therapies based on their current approvals is more likely to be felt in 2018 in terms of reduced eligible second line pool of patients in lung cancer.
We're also seeing some increase in our usage in small cell lung cancer and we would continue to expect to see some off label first line use in squamous cell carcinoma as outside of the marked [ph] label.
Marc Goodman
You are seeing over the next six months or so the second line market obviously is going to shrink, but you think you'll be able to maintain a strong share of that second line is what you are saying?
Murdo Gordon
That's right. And even that shrinking there is a rate limitation because these first line patients that are newly diagnosed and receiving treatment, their natural progression would have kept them out of that second line pool for the most part for this year and would be really a reduction in the next year revenue, so there will be pressure on our second line revenue overall in the U.S. next year.
Marc Goodman
So, if you just look at this second quarter, I mean, can second quarter be better than the first quarter? I mean is it – like how do you think about - push and pulls on it I guess without giving us guidance, you know what I mean, but?
Murdo Gordon
Yes, it's really you know whenever I talk about I-O in general, the variabilities are quite wide and when you get down into tumor specific events it's really very difficult to predict. I would say as we've talked about in the past there is a demand and I would expect uptake of pembro plus chemotherapy to be actually quite good in the community setting and that obviously will change the dynamics of lung cancer. But I expect there are shares in other tumor types to continue to strengthen.
If I look at melanoma, the regimen has performed very well in melanoma. Yervoy monotherapy is performing well in the adjuvant setting. We have really good shares now in first-line metastatic melanoma for Opdivo monotherapy. So between Opdivo monotherapy Yervoy and adjuvant and the regimen in metastatic melanoma, we've got strong shares of about 50% of that market and that is a BMS treated [ph] patient in one way or another either because of Yervoy/Opdivo or the combination. So melanoma is a strong core tumor type, our shares in renal cell carcinoma in second line are between 50% and 60% share, so that's a really high share and we expect that to continue.
Bladder is much more competitive, now five approved agents, but nonetheless we're seeing good uptake. We continue to invest significantly in share of voice across all of our core tumors and make sure that we have the appropriate resources behind the commercialization of our I-O therapies in core tumor. So yes, I think we can be quite competitive this year and I would hope for a strong quarter, but it's very dynamic.
Marc Goodman
And when you say that you've been increasing share in core tumors, so would you think about the next year, maybe two years and all the different additional indications that you are going to be getting, how much incremental spend are we talking about or is - the stage has been set pretty much?
Murdo Gordon
I think for the most part we're sized and invested appropriately across our core tumors. If we have a major surprise to the positive then we would look differently at that and we would continue to invest as appropriate. In the early days of the Opdivo launches things were coming much earlier and faster than we had anticipated and resized very rapidly and we were able to dynamically adjust as appropriate and we would do the same thing going forward. But right now we have the resources. We've expanded across Europe. We expanded rapidly in the early phases of Opdivo in the U.S. I feel good about the commercial structure.
Marc Goodman
You started to talk about the O-U.S., maybe we can just come back, so where's the growth going to come from over the next year O-U.S., what are some of the incremental geographies that have just come on so we're going to see really good growth there?
Murdo Gordon
Yes, so in Europe it really is the emergence of Italy and Spain. They were a little further behind Germany because Germany has a reimbursement system that allows initial reimbursement pending final price negotiation, whereas in Italy and Spain and France for that matter it is more of a wait-and-see. So Italy and Spain are emerging rapidly. We recently secured reimbursement for non-squamous second line in Spain, so in that we have both squamous and non- squamous. Initially we had squamous only.
In Italy and Spain now we've got all core tumors reimbursed and we are seeing some really nice evolution. France, as you know, we recognized revenue in the fourth quarter that had been deferred pending price approval. We did that for a smaller amount in Germany as well. But, you know for example, in France we're between 75% and 80% of share of PD-1 market, so the sequence of events in Europe is slightly different than in the U.S.
The regulatory approval cadence and nature of the competitor approvals is slightly different. So have, I think a larger margin of advantage in Europe. We also have Canada online now, all 10 provinces reimbursed and I would expect this to do well there. We had a large bridging program that treated a lot of patients prior to reimbursement in Canada and…
Marc Goodman
You weren’t getting paid for that?
Murdo Gordon
We were not charging for that.
Marc Goodman
For now the switch gets flipped…
Murdo Gordon
That's right.
Marc Goodman
So you could talk about, there have been a couple of studies by your competitors, Roche had a failed bladder study, AstraZeneca had a positive third line lung study, what do you think about those studies and how do you think about that, what that does to the market?
Murdo Gordon
It's hard to comment until you see data, these are [indiscernible] announcements, but I would say it has been our own experience in some cases you get surprise trial results and you need to go through the data methodically and understand why those results came in the way they did. So in bladder, I'm not sure it is necessarily a major advantage or a major change in the market given that there are five approved agents today.
Marc Goodman
If you think that the FDA thinks differently about accelerated approval because of it at all?
Murdo Gordon
It's a good question. I would say, I mean, first off we have to commend the FDA for what they've done for oncology in general. If you think about all of the accelerated approvals that they granted most of which, the vast majority of which have been by additional trials and you think about the time advantage that they created for patients and how many patients got treated under an accelerated approval and that are alive today that wouldn’t have been, that's a huge effort and it's something that Dr. Pazdur and the rest of the team at the FDA should feel very, very good about.
I would say that the spirit of the FDA from everything they've said publicly continues to remain focused on being innovative, being fast and bringing novel therapies to patients as quickly as possible while still establishing their safety and I think that's really been good. So I'm not sure this one event in a single tumor type…
Marc Goodman
Was not enough to change the…
Murdo Gordon
I wouldn’t think so, and I think we all know why we've made huge advances with the advent of immunotherapies. There's still a lot of headroom and a lot of tumor types where we've yet to show that we can cure upwards of 50% of patients and that's what we're sharing for.
Marc Goodman
Focus on Yervoy a little bit, how much Yervoy usage is mono versus combo, just give us a sense of how it is being used? And in the U.S. if you exclude some of the inventory change in the first quarter, first quarter was probably flattish with the last couple of quarters, so just – there is price push and pull is going on underneath there, so give us a sense of what's happening?
Murdo Gordon
Sure, and in the U.S. the vast majority of metastatic melanoma is combination usage of Yervoy plus Opdivo where we get some monotherapy utilization is in the adjuvant setting. We have a patient assistance program for the indicated 10 mg dose and so a lot of that product is provided at no charge to patients and we're awaiting additional clinical trials to see how that 3 versus 10 risk-benefit equation is in adjuvant, so hopefully we'll see some data there that will describe what the optimal dose is in adjuvant. I would say in the rest of the metastatic setting what we've been able to do is actually grow Opdivo monotherapy share and regimen share since this time last year. So that's been a nice evolution.
I do see it as more stable going forward. So there's not as much room for share gain except perhaps with the confirmation of the overall survival benefit study 67 of the regimen in metastatic disease I think that could be slightly positive for a regimen penetration of metastatic disease and we're doing additional descriptive analyses to try to find out which patients benefit most from the regimen.
Marc Goodman
I know when you flipped overseas, obviously a different dynamics of what's going on in Europe?
Murdo Gordon
Yes, so you got the lag to reimbursements, so we got very good reimbursement and very rapid reimbursement in the UK from nice one of the quickest approvals that they've ever given for cancer therapies on cost-effectiveness. We also secure France and Germany, so those are the three markets for the most part, a little bit in the Netherlands, Belgium that is driving the Yervoy return to growth ex-US and I think there are a few other markets that will online there and I would expect to see some modest growth in Yervoy.
Marc Goodman
So I'll flip gears to pricing in the oncology setting. So obviously up to now we haven't really seen a lot of peer pushback. I think there are a lot of pilot programs they are trying to consider right now to push back. I think there are a lot of people invested to discuss well, once those PD-1s can't be pushed back how do you think about pricing for the three to four years?
Murdo Gordon
Yes Marc, it's a good question and there is clearly a very dynamic legislative environment, policy environment and we pay close attention to that. I think for the most part in the U.S. there are early signs of some of those evolutions that we'll see and the oncology care model experiment you're seeing, commercial payers also experiment with fully integrated bundled payment models in oncology and then trying to establish performance measures in cancer as well.
I think in that world we feel very good about our ability to compete effectively to try to preserve margin, but also to better demonstrate the value of our medicines and the cost-effectiveness of our medicines. And I think in that world going forward having multiple treatment options in multiple lines of therapy across many tumors puts you in a very strong position to offer good value-based solutions to an integrated physician delivery network or payer or potentially the federal government if they enter into direct negotiations which is a big unknown.
So I think while there could be margin pressure on net price being in the position Bristol-Myers Squibb is in with the breadth of portfolio, breadth of approvals, breadth of indications, we feel good about our ability to compete there.
Marc Goodman
So you were talking about segmenting the market with respect to let's say there is a PD-1 plus another product combinations for one cancer type and then there's another PD-1 for another cancer type your synergies can't compare across if the market becomes segmented by what becomes best in class?
Murdo Gordon
Yes and the market also prefers to choose options that have a broad play across multiple indications and multiple lines and I think having that is very advantageous in a world where somebody is trying to pick, as you said, one of many PD-1s. I also think the market will segment naturally because of the biology of disease we are getting through a better understanding of which patients will respond to which kind of treatment we're seeing the emergence of some of the escape pathways or resistance mechanisms within immune checkpoint inhibition and that offers an opportunity for additional agents to come in and treat first-line patients who might progress on a PD-1 or a PD-1 plus CTLA-4. And these are the kinds of things that we've already started to look at and actually have been able to do outside of the U.S. where we have two agents in one tumor type already in metastatic melanoma.
So I think it's a very important space to watch, but is one where we have to be better and better at designing trials that show the benefit. And in some projects where this is already being done in small experiments where you said, you know to a physician group try to bring down the cost of care of cancer while improving outcomes what often happens is surgeries go down, radiation therapy treatment costs go down, diagnoses go down and drug costs go up. But the net effect is overall treatment cost comes down. So even in that world drugs are seen as a very effective solution to drive outcomes in cancer and then what we'll have to look at is the portion of total cancer care costs that we are able to demonstrate value in is something that we'll have to continue to focus on and do.
Marc Goodman
Let's switch gears to hepatitis C a market that's obviously been a little bit of a disappointment big picture, but you have this new opportunity in China which you are first in, so talk about like how long do you have the advantage and how big is the opportunity?
Murdo Gordon
Yes, I mean, first thing I would again say that the government in China along with other stakeholders like WHO, like the Chinese CDC have decided and taken very seriously that they have a healthcare crisis, a public health crisis with hepatitis C infection. We have fortunately been in China for many years and we've been in virology in China for over a decade with our HBV drug Baraclude and we were in a really good position to partner with them, design a Chinese development program for Daklinza and Sunvepra and demonstrate the benefit in a China specific population.
I would say I've been absolutely impressed by the focus of the Chinese Regulatory Association, the regulatory agency to rapidly review our data and give us an approval and the R&D organization, the regulatory organization at BMS have done a fantastic job making sure that we were not going to slow down anything that could benefit Chinese patients. The estimates range significantly. We ballpark the infected population to be about 10 million in China.
We think that there are between 100,000 and 200,000 patients in acute care right now that are seeking approved treatment, so this is a large opportunity. It could manifest itself differently than in the Western world where or in Japan where we saw rapid treatment rates of the warehouse patient population and then rapid treatment of remaining patients and a commitment by governments and payers to eradicate disease. I think that problem is so much bigger in China that that slope up could be different. What happens on the other side also could be different so...
Marc Goodman
I mean do you see the government pushing these 100,000 to 200,000 patients, on therapy quickly, I mean is that...?
Murdo Gordon
I think those patients will seek treatment quickly. They're very active, they're on We Chat boards, these are engaged patients, these are patients that know these treatments have been approved and they will seek treatment themselves. I think the screening approach is the need to be developed in China to confirm who else could be infected and bring them into care is where the government will have to focus their energy. The acute piece will happen naturally.
Marc Goodman
And how is the pricing in China versus the U.S.?
Murdo Gordon
Again, we entered this journey knowing that this was a large scale public health problem and I think that requires that we think differently about pricing and you know we're engaging in that process now with the pricing authorities both at the Federal and at the provincial or regional level in China and it is still in motion, so it's too early to comment, but we're committed to trying to help the government treat as many patients as possible there.
Marc Goodman
So we should expect a significant discount relative to what's going on in the U.S. you're not going to talk about pricing hasn't been set yet?
Murdo Gordon
Yes, I think it's hard, it hasn't been set and it's hard to say where we're going to end up. I would say that the other thing to remember is this will take a bit of time as well. We have the approval now. We're probably looking at fourth quarter before we're going to have a lot of those things resolved.
Marc Goodman
And as far as your lead time any idea on your lead time versus the competition?
Murdo Gordon
I really can't comment. I'm just pleased that our teams did everything they could, both clinically and from a regulatory perspective to give us the opportunity and now the commercial teams are moving as fast as we possibly can.
Marc Goodman
So Eliquis, this has been one of those very interesting products. I think everybody expected this market to rapidly take share from Warfarin when Rivarox [ph] came in years ago. When it didn't happen and now all of a sudden it just seems like it's just accelerating and it's nonstop. So, give us a sense of where we go, I mean it seems like Warfarin has probably got 50% of the market now or somewhere in that range maybe 55, so where do you see this in two, three, four years?
Murdo Gordon
Yes, it's a great question. I mean, we're also extremely pleased and working with Pfizer on Eliquis. We've been able to first off demonstrate the value of the Eliquis profile. We've confirmed the clinical trial findings in real world data settings and we along with other organizations have done a lot of retrospective and prospective analyses to see that we continue to have a great profile in terms of stroke and reduction in atrial fibrillation patients, but also a great leading profile. So, that, that's a really powerful differentiation platform for us and even payers are doing their own analyses and confirming some of the sponsored real world data work.
So that's helpful that payers now see us as a very cost effective option to Warfarin and potentially even other NOACs from their own analysis. When we think about the future we always look at cardiology as a leading indicator and in the cardiology market Warfarin carries roughly a 30% total prescription share compared to the 50-55 number that you cited from primary care. And when you look at new to brand shares it's even lower, so I would say that we are well on our way to having Warfarin be displaced as standard of care in these patients which should have potentially happened sooner now it’s happening.
Marc Goodman
So by the end of the decade it could really be 80-20 or 85-15 NOACs versus Warfarin could be that dramatic? I mean given the numbers you just said I mean?
Murdo Gordon
I think by the end of decade those cardiology numbers could be reflected in the broader population.
Marc Goodman
Yes, so actually let's talk about Sprycel a second, so the $2 billion charge that nobody talks about, may be you could just give us a sense of, what are the dynamics in the market, I mean I don't even know if there was a question in the conference call about it?
Murdo Gordon
Yes there wasn’t. Now the hematology team in our oncology organization have done a great job. The Sprycel story is a fantastic one when you think about even when Gleevec and Tasigna were being actively promoted we were gaining market share and not just in second line but in first line CML patients. So that team knows how to compete. They know how to describe the ideal patient for Sprycel.
We have great pediatric data now and which show really good durability of the fact and I think Sprycel has a lot of potential still in it. We do have a patent challenge in Europe that we're playing out and feel good about our ability to defend successfully and we feel that the patent real estate there is very good but nonetheless that’s a challenge.
Marc Goodman
But, I mean with Gleevec going generic, it really hasn’t stopped the development, what kind of underlying trend is?
Murdo Gordon
No, I think, again I think there is recognition that Sprycel has a superior clinical profile and I think that when you’re treating a serious disease like chronic myelogenous leukemia you want to make sure that you choose the best option and I think generic imatinib has largely cannibalized the Gleevec brand.
Marc Goodman
And it’s all happened and you still continue to grow through the market?
Murdo Gordon
For the most part, a little different country by country, but that is definitely true in the U.S.
Marc Goodman
And the other one is Orencia which is not really talked about much but continues to do really well, give us a sense are you gaining share what seems to be working, we know the market is pretty healthy?
Murdo Gordon
Yes, Orencia has been a great story, we focused about 18 months ago, 24 months ago on the early rapidly progressing patients. Orencia tended to be used in later lines of therapy after maybe one or two TNS have been used as first choice biologics. And of course the product while performing well there could offer more benefit if used earlier in the course of disease and our label allows us to promote there and that’s what we did and I think that strengthened definitely the sub-cutaneous profile, so sub-cu product has been gaining share.
In some countries we've had some really good robust share evolution in Germany in particular has had a great performance. Japan has a great trend going where we actually co-promote with Ono as a partner there and so we’ve had a really good emergence of our Orencia business. The IV market tends to be holding share while the IV market grows, so it’s mostly new demand growth coming from subcutaneous.
Marc Goodman
So maybe if you just kind of think back broadly and this question goes to any part of your business, over the next year or two what do you think will be the big surprise to us, the outside of investment community from Bristol-Myers?
Murdo Gordon
Well, at the speed of change in our portfolio will probably be a surprise to me as well but...
Marc Goodman
Go ahead make your guess.
Murdo Gordon
We are excited about the opportunity to jump in to first-line lung and we have a broad program as you know with our 227 approach. I do think China is an interesting opportunity at least for us in the short term and I think we’ll continue to perform well across the market approved indications in our oncology portfolio as well as Eliquis and the other brands.
But one of the really exciting things and we’re starting to talk about that at this upcoming ASCO is the emergence of mechanisms or products beyond Opdivo and Yervoy in oncology and starting to show hopefully what will become a broad portfolio of drugs that can help patients initially in second line settings for patients who have tried and progressed on existing immune checkpoint inhibitors like PD-1 inhibitors where we might be able to help them in second line.
And also looking at the oncology world rather than by primary tumor diagnosis or line of therapy, but much more at the biology of cancers that these patients are diagnosed with and seeing if there isn’t a more precise immunotherapy that should be offered to patients in first-line based on the biology of their tumor and the immune phenotype of the patient, that’s a really exciting potential future for oncology. And I think with our pipeline and the capabilities of our R&D organization and the ability of the commercial organization to move quickly, move rapidly on a global footprint, that’s a really exciting world and I’m hopefully going to be around to enjoy that.
Marc Goodman
It seems right now the discussion is obviously we're migrating from PD-1 fortunately to PD-1 plus maybe something else, it seems the question is do you think there is even a possibility that PD-1 is not even one of the combo products three, four years from now, how quickly do we move?
Murdo Gordon
This is definitely where I would say you should talk to Tom Lynch. I would say that there are different schools of thought, but it’s probably more about what pathway and when you treat a patient.
Marc Goodman
And just coming back to your comment on China, you said a big surprise China did you mean on the oncology side can China be a big market?
Murdo Gordon
Potentially.
Marc Goodman
When does that start to kick in?
Murdo Gordon
It’s hard to say, but what we do know is that China is clearly with this approval in hep C shown they’re committed to addressing public health and building much better healthcare in the country for their citizens. And I think if I look at what others public health crises might they want to tackle I think about had a cellular carcinoma because of the large amounts of hepatitis that they have. I think about gastric cancer, I think about lung cancer.
There are a lot of - there's some epidemiology there that is different than in the West and because of our partnership with Ono and the development plan we had is unique to Japan and other Asian markets. We’re in a really good position to address those public health needs of the Chinese population and I would say China is starting to become real in terms of an emerging first world healthcare market.
Marc Goodman
And just lastly there, how quickly was the China hep C approved the application?
Murdo Gordon
Just over a year.
Marc Goodman
Over a year?
Murdo Gordon
Yes.
Marc Goodman
And have you filed already for the…
Question-and-Answer Session
Operator
Q -
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BMY
Although it seems that the proposed budget will have $200B for infrastructure (we'll see tomorrow), that is approx half of what Obama proposed and less than what Congress was willing to approve for 2016. Nonetheless that it likely will be in the budget is a good sign for United States Steel.
Always lawsuits for big corporations. Coincidentally I know the person who helped win their recent lawsuit but that has nothing to do with my recently buying X. Merely see X as undervalued for now. Lawsuits concern long range investors. It goes up enough today and I'm out until there is a dip.
Wouldn't doubt that the insiders had info regarding the proposed budget line since the CEO has been in touch with the WH.
Could go up nicely today with infrastruture proposal:
zerohedge? @zerohedge 52m52 minutes ago
More
TRUMP'S BUDGET PROPOSAL TO INCLUDE $200 BLN FOR INFRASTRUCTURE OVER 10 YEARS -WHITE HOUSE OFFICIAL: RTRS
X
Great recovery this morning. Was following down the overall steel market (Market Vectors Steel ETF) and nothing specific to United States Steel.
X
Eiger Announces Results Demonstrating Benefit of Ubenimex and Leukotriene B4 (LTB4) Modulation in Experimental Lymphedema
- Data Supports Ongoing Phase 2 ULTRA Study of Ubenimex in Lymphedema
PALO ALTO, Calif., May 17, 2017 /PRNewswire/ --
Eiger BioPharmaceuticals, Inc., (NASDAQ:EIGR) today announced publication in Science Translational Medicine (STM) the results of extensive preclinical studies of ubenimex in which modulation of the inflammatory mediator, leukotriene B4 (LTB4), improved experimental lymphedema. Targeted reduction of LTB4 with ubenimex reversed edema, improved lymphatic function and restored lymphatic architecture in experimental models of lymphedema. The technology was invented by Stanley Rockson, MD, Professor of Cardiovascular Medicine at Stanford University, which Eiger exclusively licensed in 2015. Based on these findings, Eiger is conducting ULTRA, a multi-center, Phase 2 clinical study of ubenimex in Secondary Lymphedema, currently enrolling at multiple sites in the U.S. and Australia.
Lymphedema is a state of vascular functional insufficiency in which decreased lymphatic clearance of interstitial fluid leads to edema formation, and progressive, debilitating architectural alterations of the skin and supporting tissues. Lymphedema typically manifests itself in an arm or leg, but can affect other parts of the body. Lymphedema often causes long-term physical, psychological, and social problems for patients and significantly impacts quality of life. There is no approved pharmacologic therapy.
"We have demonstrated for the first time that a naturally-occurring inflammatory substance known as LTB4 is elevated in both animal models of lymphedema as well as human patients with lymphedema and that elevated LTB4 is associated with tissue inflammation and impaired lymphatic function," said Stanley Rockson, MD, Professor of Cardiovascular Medicine at Stanford University and Lead Investigator for ULTRA. "Lymphedema is a devastating disorder and an approved pharmacologic therapy is urgently needed. I believe that LTB4 is a promising drug target for the treatment of lymphedema, and I'm pleased to be the lead investigator for the ULTRA clinical study of ubenimex in secondary lymphedema. ULTRA will pave the way for investigating ubenimex in other types of lymphedema, including upper extremity and primary lymphedema."
Tian et al., Sci. Transl. Med. 9, "Leukotriene B4 Antagonism Ameliorates Experimental Lymphedema", May 10, 2017.
About LTB4 and Ubenimex
Leukotriene B4 (LTB4) is a naturally-occurring inflammatory substance known to be elevated in both preclinical models of secondary lymphedema as well as human lymphedema disease. Elevated LTB4 causes inflammation resulting in tissue inflammation and impaired lymphatic function. Targeted pharmacologic inhibition of LTB4 promotes lymphatic repair and reverses lymphedema disease in treated animals.
Ubenimex is a well-characterized, oral, small-molecule, inhibitor of leukotriene A4 hydrolase (LTA4H), the enzyme responsible for the formation of the pro-inflammatory mediator, LTB4.
Ubenimex is approved in Japan (brand name Bestatin™) as an adjunct to chemotherapy agents to extend survival and to maintain remission after treatment for acute non-lymphocytic leukemia in adults. Ubenimex has been used for over 25 years in Japan and remains commercially available through Nippon Kayaku. Ubenimex is not approved for any indication in the US or Europe.
About Lymphedema
Lymphedema can be either primary (hereditary) or secondary (caused by another disease or condition). Primary lymphedema is caused by the absence of certain lymph vessels at birth or abnormalities in the lymphatic vessels and can be divided into three forms, depending on age of onset. Secondary lymphedema usually develops as a result of a lymph vessel blockage or interruption that alters the flow of lymph through the lymphatic system and can develop from an infection, malignancy, surgery, scar tissue formation, trauma, radiation, or other cancer treatment. Primary lymphedema and secondary lymphedema are large unmet medical needs, as both can be debilitating and negatively impact quality of life. There is no approved pharmacologic treatment for lymphedema.
About the ULTRA Phase 2 Study
ULTRA is a multi-center, randomized, double-blind, placebo-controlled Phase 2 study of ubenimex in patients with secondary lymphedema of the lower limb(s). Up to forty patients may be randomized in a 1:1 ratio to receive ubenimex or matching placebo, administered orally for a total of 24 weeks. The study will assess clinical, biomarker, histologic and patient-reported outcomes.
About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare diseases. The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which an effective therapy is urgently needed.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "project," "target," "will" and other words and terms of similar meaning. Examples of such statements include, but are not limited to, whether or not pegylated interferon lambda-1a or lonafarnib or ubenimex or exendin 9-39 may be further developed and approved, and whether promising earlier clinical study results will be repeated in larger, later clinical studies, statements relating to the availability of cash for Eiger's future operations, Eiger's ability to develop its drug candidates for potential commercialization, the timing of the commencement and number and completion of Phase 2 trials and whether the products can be successfully developed or commercialized. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the "Risk Factors" sections in the Quarterly Report on Form 10-Q for the three-month period ended March 31, 2017 and other periodic reports filed with the SEC by Eiger. Eiger does not assume any obligation to update any forward-looking statements, except as required by law.
Investors: Ingrid Choong, PhD, Eiger BioPharmaceuticals, 650-619-6115, ichoong@eigerbio.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/eiger-announces-results-demonstrating-benefit-of-ubenimex-and-leukotriene-b4-ltb4-modulation-in-experimental-lymphedema-300459051.html
SOURCE Eiger BioPharmaceuticals, Inc.
____________________________________________
EIGR
Health Canada approves OPDIVO® (nivolumab) for the treatment of squamous cell carcinoma of the head and neck
Latest approval of OPDIVO® marks the fourth indication for the immuno-oncology treatment offering hope for improved survival to more patients
MONTREAL, May 17, 2017 /CNW/ -
Health Canada has approved OPDIVO® (nivolumab) for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy – the first and only immuno-oncology treatment in Canada for this indication1. Immuno-oncology uses the body's own immune system to fight cancer cells.
"Head and neck cancers can have devastating consequences for patients and their families. Traditional risk factors that include tobacco and alcohol consumption and the increasingly important role of Human Papilloma Virus (HPV) infection are leading to worrisome increases in oropharyngeal SCCHN," said Dr. John Walker, assistant professor of oncology, University of Alberta. "The approval of OPDIVO® is an important advance for patients with cancers of the head and neck that have high unmet need and limited treatment options."
The data to support the approval was based on CheckMate -141, a phase three clinical trial that was stopped early when an independent data review showed the study met its primary endpoint, demonstrating superior overall survival (OS) in patients receiving OPDIVO® compared to the control arm.
OPDIVO® has now been approved in four distinct tumour types within the last 18 months in Canada. It was first approved in September 2015 for the treatment of adult patients with metastatic BRAF V600 wild-type melanoma; followed by approval for locally advanced or metastatic non-small cell lung cancer (NSCLC) in March 2016 and renal cell carcinoma (RCC), a form of kidney cancer in April 2016.
Head and neck cancers include oral cavity, larynx/hypopharynx and salivary gland cancers, which affect thousands of Canadians and represent a large worldwide burden of disease because treatment can impact an individual's ability to breathe, speak and swallow.2 According to statistics, oral cavity cancer (including the oropharynx subsite), for instance, is the 13th most common newly diagnosed cancer and the 15th most common cause of death due to cancer for adults.3 The five year survival rate for head and neck cancers is reported as less than four percent for metastatic Stage IV disease.4
About CheckMate -141
CheckMate -141 was a Phase 3, open-label, randomized study of OPDIVO® versus investigator's choice of therapy in previously treated patients with SCCHN who have tumor progression on or within six months of platinum therapy in the primary, recurrent, or metastatic setting. The trial randomized 361 patients 2:1 to receive either OPDIVO® 3 mg/kg intravenously every two weeks or investigator's choice (cetuximab/methotrexate/docetaxel) until documented disease progression or unacceptable toxicity. The primary endpoint was OS. Secondary endpoints included objective response rate and progression free survival.
"Our Canadian team has been committed to working together for patients to transform survival expectations," said Dr. Nawal Peacock, president and general manager, Bristol-Myers Squibb Canada Co. "Health Canada's latest approval of OPDIVO® for cancer of the head and neck is a testament of our success in advancing the OPDIVO® clinical development program in hard-to-treat cancers. This newest advancement will offer hope for longer survival to more patients suffering from head and neck cancers."
About OPDIVO®
OPDIVO® is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body's own immune system to help restore anti-tumor immune response. By harnessing the body's own immune system to fight cancer, OPDIVO® has become an important treatment option across multiple cancers.
OPDIVO®'s leading global development program is based on Bristol-Myers Squibb's scientific expertise in the field of immuno-oncology and includes a broad range of clinical trials 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. The OPDIVO® trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from OPDIVO® across the continuum of PD-L1 expression.
In July 2014, OPDIVO® was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. OPDIVO® is currently approved in more than 60 countries, including the United States, the European Union and Japan. In October 2015, the company's OPDIVO® and YERVOY® combination regimen was the first immuno-oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including Canada, the United States and the European Union.
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 that will raise survival expectations in hard-to-treat cancers and will change the way patients live with cancer.
We are leading the scientific understanding of I-O through our extensive portfolio of investigational and approved agents, including the first combination of two I-O agents in metastatic melanoma, and our differentiated clinical development program, which is studying broad patient populations across more than 35 types of cancers with 13 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs uniquely position us to advance the science of combinations across multiple tumors and potentially deliver the next wave of I-O combination regimens 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 inform which patients will benefit most from I-O therapies.
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 Bristol-Myers Squibb Canada Co.
Bristol-Myers Squibb Canada Co. is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, 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 global operations, visit www.bms.com. Bristol-Myers Squibb Canada Co. has been delivering innovative medicines for serious diseases to Canadian patients in the areas of cardiovascular health, oncology, immunoscience and virology for over 80 years. Bristol-Myers Squibb Canada Co. employs 300 people across the country. For more information, please visit www.bmscanada.ca.
References:
_________________
1 Bristol-Myers Squibb Canada Co. OPDIVO™ Canadian Product Monograph, Revised: May 12, 2017.
2 ICES. Head and Neck Cancer Surgery in Ontario: Briefing Note. http://www.ices.on.ca/~/media/Files/Atlases-Reports/2015/Head-Neck-Cancer-Surgery-Atlas/ICES106HeadNeckCancerAtlasbriefingnoteAccessible.ashx. Accessed May 2017.
3 ICES. Head and Neck Cancer Surgery in Ontario: Briefing Note. http://www.ices.on.ca/~/media/Files/Atlases-Reports/2015/Head-Neck-Cancer-Surgery-Atlas/ICES106HeadNeckCancerAtlasbriefingnoteAccessible.ashx. Accessed May 2017.
4 Argiris, Athanassios, Arlene Forastiere. American Cancer Society. "Prognostic Factors and Long-Term Survivorship in Patients with Recurrent or Metastatic Carcinoma of the Head and Neck." Updated September 27, 2004.
SOURCE Bristol-Myers Squibb Canada
For further information: Monica Flores, Public Affairs Lead, Bristol-Myers Squibb Canada, 514.333.3845, monica.flores@bms.com; Jacqueline Zonneville, Director, GCI Group, 416.486.2603, jacqueline.zonneville@gcicanada.com
____________________________________________
http://www.newswire.ca/news-releases/health-canada-approves-opdivo-nivolumab-for-the-treatment-of-squamous-cell-carcinoma-of-the-head-and-neck-622741524.html
BMY
Wrong day for this blog, but has all of the bullish theses regarding BMY:
__________________________________________________
I Think Bristol-Myers Squibb Has Finally Bottomed
May 16, 2017 9:42 AM ET|14 comments| About: Bristol-Myers Squibb Company (BMY), Includes: PFE
Nicholas Ward
Long only, long-term horizon, dividend investing, value
(4,927 followers)
Summary
BMY is my largest holding in the healthcare space. This wasn't exactly on purpose, but I do believe the market has mispriced the stock to the downside.
In this article I explain why I'm bullish and believe that the stock has found a solid foundation in the low $50s.
A near 3% yield alongside strong M&A rumors and double-digit top-line growth should bolster the stock at current levels.
(continues)
https://seekingalpha.com/article/4073683-think-bristol-myers-squibb-finally-bottomed?app=1&auth_param=udil:1chm0eh:1219ac0025a48b77c9a00951e9cba983&uprof=46
BMY
Thanks, had seen that, but wasn't thinking it was of such import. Suppose this news together with the MRK news from yesterday really weighing down. (MRK is currently down even more).
BMY
Strange day. BMY usually trades in coordination with LABU, but with less volatility. LABU up ~ 4% and BMY slightly down.
BMY low volume:
Share Volume 3,361,897
90 Day Avg. Daily Volume 11,806,144
BMY
Ransomware infections reported worldwide
By Chris Baraniuk
Technology reporter
Infections have been reported at organisations around the world
A massive ransomware campaign appears to have infected a number of organisations around the world.
Screenshots of a well known program that locks computers and demands a payment in Bitcoin have been shared online by parties claiming to be affected.
There have been reports of infections in the UK, US, China, Russia, Spain, Italy, Vietnam, Taiwan and others.
Security researchers are linking the incidents together.
One cyber-security researcher tweeted that he had detected 36,000 instances of the ransomware, called WannaCry and variants of that name.
"This is huge," he said.
The UK's National Health Service (NHS) was also hit by a ransomware outbreak and screenshots of the WannaCry program were shared by NHS staff.
A number of Spanish firms were among the apparent victims elsewhere in Europe.
Telecoms giant Telefonica said in a statement that it was aware of a "cybersecurity incident" but that clients and services had not been affected.
Power firm Iberdrola and utility provider Gas Natural were also reported to have suffered from the outbreak.
There were reports that staff at the firms were told to turn off their computers.
Screenshots of WannaCry with text in Spanish were also shared online.
Media captionWhat is ransomware?
In Italy, one user shared images appearing to show a university computer lab with machines locked by the same program.
Bitcoin wallets seemingly associated with the ransomware were reported to have already started filling up with cash.
"This is a major cyber attack, impacting organisations across Europe at a scale I've never seen before," said security architect Kevin Beaumont.
According to security firm Check Point, the version of the ransomware that appeared today is a new variant.
"Even so, it's spreading fast," said Aatish Pattni, head of threat prevention for northern Europe.
Several experts monitoring the situation have linked the infections to vulnerabilities released by a group known as The Shadow Brokers, which recently claimed to have dumped hacking tools stolen from the NSA.
A patch for the vulnerability was released by Microsoft in March, but many systems may not have had the update installed.
Some security researchers have pointed out that the infections seem to be deployed via a worm - a program that spreads by itself between computers.
___________________________________________________
http://www.bbc.com/news/technology-39901382
CYBR
NHS cyberattack: hospitals and GPs across the UK hit by hack
An NHS hack has shut down IT systems and people are told not to go to A&E unless life-threatening emergency
By VICTORIA WOOLLASTON
Friday 12 May 2017
Reports are coming in of an NHS cyberattack hitting hospitals across the UK.
The NHS hack is said to be “creeping” across the country with NHS staff and health journalists tweeting images of the ransomware. So far, hospitals in the north, south west of England and the south are said to have been hit following a supposed hack on Friday afternoon. Further reports said GPs were also being targeted.
East and North Hertfordshire NHS confirmed it has experienced a “major IT problem, believed to be caused by a cyberattack”. In a statement, NHS Digital confirmed a number of NHS organisations had been affected by a ransomware attack. “The investigation is at an early stage but we believe the malware variant is Wanna Decryptor,” a spokesperson said.
_______________________________________________________-
https://www.wired.co.uk/article/nhs-cyberattack-ransomware-security
CYBR
U.S. Steel has multiple domestic and international facilities.[60]
Of note in the United States is Clairton Works, Edgar Thomson Works, and Irvin Plant, which are all members of Mon Valley Works [61] just outside Pittsburgh, Pennsylvania. Clairton Works is the largest coking facility in North America. Edgar Thomson Works is one of the oldest steel mills in the world. The Company acquired Great Lakes Works and Granite City Works, both large integrated steel mills, in 2003 and is partnered with Severstal North America in operating the world's largest electro-galvanizing line, Double Eagle Steel Coating Company at the historic Rouge complex in Dearborn, Michigan.
U.S. Steel's largest domestic facility is Gary Works, in Gary, Indiana; Gary is also home to the U.S. Steel Yard baseball stadium.
U.S. Steel operates a tin mill in East Chicago now known as East Chicago Tin.[62] The mill was idled in 2015.[63]
U.S. Steel operates a sheet and tin finishing facility in Portage, Indiana, known as Midwest Plant, acquired after the National Steel Corporation bankruptcy. U.S. Steel acquired National Steel Corporation and operates Great Lakes Works in Ecorse, Michigan, Midwest Plant in Portage, Indiana, and Granite City Steel in Granite City, Illinois. In 2008 a major expansion of Granite City was announced, including a new coke plant with an annual capacity of 650,000 tons.[64]
U.S. Steel operates Fairfield Works in Fairfield, Alabama (Birmingham), employing 1,500 people, and operates a sheet galvanizing operation at the Fairless Works facility in Fairless Hills, Pennsylvania, employing 75 people.
U.S. Steel operates five pipe mills: Fairfield Tubular Operations in Fairfield, Alabama (Birmingham), Lorain Tubular Operations in Lorain, Ohio, McKeesport Tubular Operations, in McKeesport, PA, Texas Operations (Formerly Lone Star Steel) in Lone Star, TX, and Bellville Operations in Bellville, TX.
U.S. Steel operates two major taconite mining and pelletizing operations in northeastern Minnesota's Iron Range under the operating name Minnesota Ore Operations. The Minntac mine is located near Mountain Iron, Minnesota and the Keetac mine is near Keewatin, Minnesota. U.S. Steel announced on February 1, 2008 that it would be investing approximately $300 Million in upgrading the operations at Keetac, a facility purchased in 2003 from the now-defunct National Steel Corporation.[65]
U.S. Steel has completely closed two of its major integrated mills. The Duluth Works in Duluth, Minnesota closed in 1987, followed by South Chicago's South Works in 1992.
Internationally, U.S. Steel operates facilities in Slovakia (former East Slovakian Iron Works in Košice). It also operated facilities in Serbia – former Sartid with facilities in Smederevo (steel plant, hot and cold mill) and Šabac (tin mill).[66]
U.S. Steel added facilities in Texas with the purchase of Lone Star Steel Company in 2007.[67]
The company operates 2 joint ventures in Pittsburg, California with POSCO of South Korea.[68]
U.S. Steel added facilities in Hamilton and Nanticoke, Ontario, Canada with the purchase of Stelco (now U.S. Steel Canada) in 2007.[69]
The company opened a training facility, the Mon Valley Works Training Hub, in Duquesne, Pennsylvania in 2008. The state-of-the-art facility, located on a portion of the property once occupied by the company's Duquesne Works, serves as the primary training site for employees at U.S. Steel's three Pittsburgh-area Mon Valley Works locations. This site also served as the company's temporary technical support headquarters during the 2009 G20 Summit.[70]
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https://en.wikipedia.org/wiki/U.S._Steel
X