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Got to wonder how Trump's trade policies are impacting BMY today?
http://www.bms.com/sustainability/worldwide_facilities/asia/Pages/default.aspx
BMY
I've seen a couple of speculations lately:
Meg TirrellVerified account ?@megtirrell 24h24 hours ago
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Jefferies says calm down on $BMY, suggests takeout $50/shr poss if things go further south in lung cancer; likely buyers $JNJ $PFE $SNY $NVS
From SA article:
David Katz, founder of $760 million value investment firm $760 million Matrix Asset Advisors, said he expects a lot of M&A in the drug company and health care space in 2017. Katz, who is a contributor to Real Money, noted Pfizer (PFE) , Merck (MRK) , Johnson & Johnson (JNJ) or Novartis (NVS) are all capable of acquiring Bristol-Myers. He added that Bristol-Myers's large immune-oncology drug portfolio, led by Opdivo, could make it an attractive candidate to any of the largest global pharmaceutical companies. "There are only a few companies big enough that would be capable of making an acquisition of Bristol," he said.
Last week, for instance, Pfizer CFO Frank D'Amelio told a J.P. Morgan Healthcare conference that he expects more tuck-in and bolt-on acquisitions for the overall industry, adding that he thought large-scale M&A was possible.
Chesney also acknowledged that there has been "persistent chatter, given some of the excitement around the world of immuno-oncology," that Bristol-Myers Squibb could become a target for acquisition.
However, he suggested that the most capable buyers may not be interested. Johnson & Johnson hasn't pursued large scale commercial transactions in the pharmaceutical space and is already quite diversified in with operations involving drugs, medical devices and consumer products. He added that Johnson & Johnson is more focused on make smaller development stage asset acquisitions, suggesting it wouldn't want to make the kind of transformative acquisition a Bristol purchase would entail.
Chesney added that he thought it was unlikely that Merck, the closest competitor to Bristol in the oncology business, would have any interest, largely because the two companies already overlap significantly.
The most widely speculated potential buyer for Bristol-Myers is Pfizer - many analysts and investors contend that the New York based company would see more of a benefit in acquiring Bristol.
Chesney contends that while Pfizer has clearly expressed interest in similar assets in the past, its willingness to enter into a significant transaction for Bristol-Myers could be limited by the shifting sands in the immuno-oncology space as well as Pfizer's own efforts to develop an in-house program, including a partnership with German-based Merck KGaA.
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http://investorshub.advfn.com/boards/read_msg.aspx?message_id=127918772
I'm going to follow up on your reference re: Dr. Wolchok. The iHub message isn't available to those who aren't subscribed to that board.
Obviously MRK and BMY have some interesting ongoing agreements as seen by the timing of BMY's announcements on Friday, and I saw some speculation that BMY agreed to slow down the accelerated regulatory pathway as part of the settlement.
I'm surprised that BMY didn't recover more yesterday than it did. I know the way back up always takes longer than the fall, but the funds reaped from the settlement far surpass the 3-6 month delay. Am I wrong in this?
BMY
Bristol-Myers: An Activist Shows Up, Finally
Jan. 23, 2017 6:37 AM ET|5 comments| About: Bristol-Myers Squibb Company (BMY), Includes: AGN, MRK, PFE, WBA
Summary
BMY has an activist shareholder.
But the big question is whether JANA Partners will step up and push for change.
And there are catalysts JANA can force, from a buyout to a spin off.
Bristol Myers (NYSE:BMY), the $100 billion market cap drug maker now calls billionaire activist Barry Rosenstein of JANA Partners as a shareholder. Per JANA's fourth quarter investor letter, it has made Bristol-Myers a top holding. Although it hasn't waged a 'full blown' activist campaign, it could be working behind the scenes. Plus, JANA is no stranger to waging proxy battles to force change. And there's plenty of 'change' opportunities at Bristol-Myers. The stock is down 20% over the last year and trading at 52-week lows. This comes after its immuno-oncology drug Opdivo failed to meet a Phase II trial, and Merck (NYSE:MRK) grabbed some market share. Still, Bristol-Myers has a huge opportunity with Opdivo - which is expected to become one of the best selling drugs in the world and move from sales of just $1 billion to over $13 billion in a few years.
Opdivo, which is being heavily advertised in the media, had sales near $1 billion in 2015, but analysts predict it could go much, much higher, hitting nearly $13 billion annually within a few years. Despite that failure, Opdivo is in more than 50 clinical trials, which means the drug could become one of the best-selling drugs in the world.
Be on the lookout for JANA to step it up over the next couple weeks, if they plan to push for management and board change - where the board nominee deadline for Bristol-Myers hits Feb. 2. JANA did effectively just end its campaign at Walgreens (NASDAQ:WBA) recently and is likely on the hunt for a new target. Yet, it's more likely that JANA stays in the shadows for now, seeing how Bristol-Myers progresses over the next few months. In all likelihood, JANA will want to stay constructive with these holding, offering positive feedback and possible theses for unlocking value.
The key play is to convince Bristol-Myers to diversify a bit, and take away its reliance on cancer drug Opdivo. The answer to that is acquisitions, although I'm not a huge fan of forced acquisitions. The other - and more likely - diversification answer is to merge with another major pharma company. Major mergers should be a key theme for 2017 (thanks to Donald Trump's de-regulation plans) and pharma is ripe, with the likes of Pfizer (NYSE:PFE) already on the prowl - as Pfizer is looking to build its own in-house program of immuno-oncology. As well, Merck could also be a suitable buyer for Bristol-Myers - being its largest direct competitor. But Pfizer is one of the few companies with the wherewithal, and it's hungry after its planned merger with Allergan (NYSE:AGN) fell through.
In the end, Bristol-Myers is one of the more appealing healthcare stocks. It's now even more interesting with JANA Partners involved. It's not entirely cheap, which helps with getting the company overlooked. But all the better. It's still a growth story, with the best expected five year earnings growth of any major drug maker. It's a growth story with a solid 3.2% dividend yield, and with plenty of optionality in the form of JANA, spin offs or buyouts. Part of Bristol-Myers' issue is the suggested over-reliance on one key drug, but the immuno-oncology space is attractive and Bristol-Myers should attract buyers should it decide to put on the auction block.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
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http://seekingalpha.com/article/4038557-bristol-myers-activist-shows-finally
BMY
Seems like easy money given they still have the opportunity modeled by Goldman this morning ("Goldman believes the interim analysis will occur in later this year with a potential regulatory filing in Q4. Its valuation models assume the launch of the combo by 2018, with $1B in sales in first-line lung cancer by 2020 (with a 25% risk adjustment). It adds that Bristol's current price reflects no value for Opdivo in lung cancer and any weakness represents a buying opportunity.") and additionally BMY receives almost 2/3rd's that figure without all the development, production and marketing efforts.
BMY
Bristol-Myers Squibb and Ono Pharmaceutical Company Enter Settlement and License Agreement with Merck to Resolve PD-1 Antibody Patent Litigation
01/20/2017
Merck to pay Bristol-Myers Squibb and Ono royalties on global sales of Keytruda through 2026, and lump-sum payment of $625 million
Ends all global patent-infringement litigation against Merck’s sale of Keytruda
Recognizes validity of Bristol-Myers Squibb and Ono’s PD-1 antibody patents
NEW YORK & OSAKA, Japan--(BUSINESS WIRE)--
Bristol-Myers Squibb Company (NYSE:BMY) and Ono Pharmaceutical Company, Ltd. today announced the companies have signed a global patent license agreement with Merck & Co., Inc. (NYSE: MRK) to settle all patent-infringement litigation related to Merck’s PD-1 antibody Keytruda (pembrolizumab). The agreement will result in the dismissal with prejudice of all patent litigation between the companies pertaining to Keytruda. Bristol-Myers Squibb and Ono, who discovered and developed the PD-1 antibody Opdivo (nivolumab), had asserted in litigation that Merck’s sale of Keytruda infringed the companies’ patents relating to the use of PD-1 antibodies to treat cancer in the U.S., Europe (United Kingdom, Netherlands, France, Germany, Ireland, Spain and Switzerland), Australia, and Japan.
As part of the agreement, Merck will make an initial payment of $625 million to Bristol-Myers Squibb and Ono. Merck is also obligated to pay ongoing royalties on global sales of Keytruda of 6.5% from January 1, 2017 through December 31, 2023, and 2.5% from January 1, 2024 through December 31, 2026. Under the agreement, the companies have also granted certain rights to each other under their respective patent portfolios pertaining to PD-1. The royalties will be shared between Bristol-Myers Squibb and Ono in a 75/25 percent allocation, respectively.
“Bristol-Myers Squibb and Ono’s agreement with Merck protects our scientific discoveries and validates the strong intellectual property rights we secured as the early innovators in the science of PD-1, a key mechanism in Immuno-Oncology that has proven to have transformational impact in cancer care,” says Giovanni Caforio, M.D., chief executive officer, Bristol-Myers Squibb. “Today’s agreement is also a good decision for patients as it supports the continuation of ongoing research and maintains access to anti-PD-1 therapies for cancer patients around the world.”
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 was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in 60 countries including the United States, Japan, and in 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 patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin. 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.
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 4.9% (13/263) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 3.4% (9/263) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=8).
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, among all patients (safety population [n=263]), adverse reactions leading to discontinuation (4.2%) or to dosing delays (23%) occurred. The most frequent serious adverse reactions reported in ≥1% of patients were infusion-related reaction, pneumonia, pleural effusion, pyrexia, rash and pneumonitis. Ten patients died from causes other than disease progression, including 6 who died from complications of allogeneic HSCT. Serious adverse reactions occurred in 21% of patients in the safety population (n=263) and 27% of patients in the subset of patients evaluated for efficacy (efficacy population [n=95]). 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 infections, and sepsis.
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, among all patients (safety population [n=263]) and the subset of patients in the efficacy population (n=95), respectively, the most common adverse reactions (≥20%) were fatigue (32% and 43%), upper respiratory tract infection (28% and 48%), pyrexia (24% and 35%), diarrhea (23% and 30%), and cough (22% and 35%). In the subset of patients in the efficacy population (n=95), the most common adverse reactions also included rash (31%), musculoskeletal pain (27%), pruritus (25%), nausea (23%), arthralgia (21%), and peripheral neuropathy (21%). 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 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.
Please see U.S. Full Prescribing Information, including Boxed WARNING regarding immune-mediated adverse reactions, for YERVOY.
Please see U.S. Full Prescribing Information for OPDIVO.
About the Bristol-Myers Squibb and Ono Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 2014, Ono and Bristol-Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
About Ono Pharmaceutical Company, Ltd.
Ono Pharmaceutical Company, Ltd., headquartered in Osaka, Japan, is an R&D-oriented pharmaceutical company committed to create innovative medicines in specific areas. It focuses especially on the oncology and diabetes areas. For more information, please visit the company’s website at http://www.ono.co.jp/eng/index.html.
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 the settlement and license agreement will prevent any future litigation related to PD-1 antibodies or that the Company will receive all future royalties described in this release as expected. 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, 2015 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/20170120005582/en/
Source: Bristol-Myers Squibb Company
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BMY
I'm not thrilled especially since my inclination was to sell a week ago @ $59, but as is got a few more pre-market at $50.50.
Can't imagine it will go to the high 30's without being bought out. Where do you hear that management is uncaring? I haven't been aware of this issue, although a little ticked that their announcement was after normal trading hours.
BMY
Goldman says Bristol-Myers' Opdivo/Yervoy in front-line lung cancer not dead yet; shares down 7% premarket
Jan. 20, 2017 7:55 AM ET|About: Bristol-Myers Squibb C... (BMY)|By: Douglas W. House, SA News Editor
Bristol-Myers Squibb (NYSE:BMY) is off 7% premarket on average volume in response to yesterday's announcement that it will not seek accelerated approval of the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the first-line treatment of lung cancer [competitor Merck (NYSE:MRK) is up 4% premarket].
Goldman Sachs says Bristol's announcement doesn't necessarily mean the end of its effort to develop the combo for lung cancer. It says the company did not take an interim look at the data and the Data Monitoring Committee did not recommend to stop the trial (the company based its decision on a "review of currently available data").
Goldman believes the interim analysis will occur in later this year with a potential regulatory filing in Q4. Its valuation models assume the launch of the combo by 2018, with $1B in sales in first-line lung cancer by 2020 (with a 25% risk adjustment). It adds that Bristol's current price reflects no value for Opdivo in lung cancer and any weakness represents a buying opportunity.
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http://seekingalpha.com/news/3236345-goldman-says-bristol-myers-opdivo-yervoy-front-line-lung-cancer-dead-yet-shares-7-percent?app=1&uprof=46#email_link
BMY
Hopefully, been one step forward and two back.
BMY
Bristol Myers Squibb : An Application for the Trademark "ORBRODA" Has Been Filed by Bristol-Myers Squibb
01/19/2017 | 07:49pm CET
By a News Reporter-Staff News Editor at Pharma Business Week --
According to news reporting originating from Washington, D.C., by NewsRx journalists, a trademark application has been made for "ORBRODA" by Marilyn F. Kelly, representing Bristol-Myers Squibb. This application was made available to the public on January 06, 2017 (see also Pharmaceutical Companies).
The serial number for this application is 87284360.
The international trademark goods and services class code for this trademark application is 005.
As submitted by the applicant, this trademark application relates to the following goods and services: Pharmaceutical preparations for human use.
The owner/registrar information for this application is: Marilyn F. Kelly, Bristol-Myers Squibb, P.o. Box 4000, Trademarks Dept., Mailstop D33-05, Princeton, NJ 08648-4000.
Keywords for this news article include: Pharmaceutical Companies, Trademarks, Bristol-Myers Squibb Company.
Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2017, NewsRx LLC
(c) 2017 NewsRx LLC, source Health Newsletters
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http://www.4-traders.com/BRISTOL-MYERS-SQUIBB-CO-11877/news/Bristol-Myers-Squibb-An-Application-for-the-Trademark-ORBRODA-Has-Been-Filed-by-Bristol-Myers-Sq-23721874/
BMY
Opdivo (nivolumab) Demonstrated Efficacy and Improved Survival in Patients with Previously Treated Advanced Gastric Cancer in a Randomized Phase 3 Study
By Business Wire, January 19, 2017, 09:00:00 AM EDT
Opdivo demonstrated a 37% reduction in the risk of death compared to placebo
12-month overall survival rates were 26.6% in Opdivo-treated patients compared to 10.9% in placebo-treated patients
PRINCETON, N.J.--(BUSINESS WIRE)--
Bristol-Myers Squibb Company (NYSE:BMY) announced today the results of ONO-4538-12 demonstrating Opdivo (nivolumab) significantly reduced the risk of death by 37% (HR 0.63; p<0.0001) in patients with previously treated advanced gastric cancer refractory to or intolerant of standard therapy, a condition without current standard-of-care treatments. ONO-4538-12 is a Phase 3, randomized, double-blind, placebo-controlled clinical trial evaluating Opdivo's efficacy and safety in such patients. The primary endpoint of the study is overall survival (OS). Median OS was 5.32 months (95% CI: 4.63 to 6.41) for patients treated with Opdivo, compared to 4.14 months (95% CI: 3.42 to 4.86) (p<0.0001) for those treated with placebo. In addition, the 12-month OS in the Opdivo group was 26.6% (95% CI: 21.1 to 32.4) versus 10.9% (95% CI: 6.2 to 17.0) in the placebo group. Patients treated with Opdivo also experienced an objective response rate of 11.2% (95% CI: 7.7 to 15.6) compared to 0% (95% CI: 0.0 to 2.8) with placebo and a median duration of response of 9.53 months (95% CI: 6.14 to 9.82), which were secondary endpoints.
The safety profile of Opdivo was consistent with previously reported studies in solid tumors. Treatment-related adverse events (TRAEs) of any grade and Grade 3/4 occurred in 42.7% versus 26.7% and 10.3% versus 4.3% of Opdivo-treated and placebo-treated patients, respectively. The Grade 3/4 TRAEs reported in more than 2% of patients were diarrhea, fatigue, decreased appetite, pyrexia, as well as increased AST and ALT in the Opdivo group, and fatigue and decreased appetite in the placebo group. The Opdivo and placebo-treated patients had similar rates of TRAEs leading to discontinuation, 2.7% and 2.5%, respectively.
The ONO-4538-12 data are being presented today in a late-breaking oral presentation from 2:00 - 3:30 p.m. PST (Abstract #2) at the 2017 Gastrointestinal Cancers Symposium in San Francisco, Calif.
"ONO-4538-12 is the first randomized, Phase 3 Immuno-Oncology trial to demonstrate improved survival for patients with previously treated advanced or recurrent gastric cancer. We find these results with Opdivo encouraging, as gastric cancer is a leading cause of cancer death globally and unmet needs remain for patients with advanced forms of this disease who become intolerant to chemotherapy or for whom such treatment has failed," said Ian M. Waxman, M.D., development lead, Gastrointestinal Oncology, Bristol-Myers Squibb.
"These results show a clinical benefit with Opdivo for patients with pretreated advanced or recurrent gastric cancer and establish a strong basis for conducting additional studies with Opdivo as a treatment for patients with gastric cancer," added lead study investigator Yoon-Koo Kang, M.D., Ph.D., of the Department of Oncology at the University of Ulsan College of Medicine, Asan Medical Center in Seoul, Korea.
About ONO-4538-12
ONO-4538-12 (NCT02267343) is a Phase 3, randomized, double-blind, placebo-controlled clinical trial conducted in Japan, Korea and Taiwan, evaluating the efficacy and safety of Opdivo in patients with unresectable (unable to be removed with surgery) previously treated advanced or recurrent gastric cancer, including gastroesophageal junction cancer, refractory to or intolerant of standard therapy. This trial was conducted by Ono Pharmaceutical Co. Ltd. of Japan, Bristol-Myers Squibb's development partner for Opdivo.
In ONO-4538-12, Opdivo 3 mg/kg or placebo was administered every two weeks until disease progression or discontinuation due to unacceptable toxicity. The primary endpoint, OS, was assessed for the superiority of Opdivo versus placebo. The secondary endpoints included objective response rate, duration of response, progression free survival, best overall response, time to response, disease control rate and safety measures.
About Gastric Cancer
Gastric cancer, also known as stomach cancer, is the fifth most common malignancy in the world, with more than 950,000 patients diagnosed each year, and is the third leading cause of cancer-related death, with more than 720,000 deaths reported annually. The prevalence of gastric cancer is higher in East Asian countries than in Western countries. While the five-year survival rate for people with gastric cancer is 30.4%, this rate falls to approximately 5% for those whose gastric cancer has metastasized (or spread). Because no standard-of-care treatment options exist for patients with unresectable advanced or recurrent gastric cancer after chemotherapy, there remains an important unmet medical need for patients with this condition.
Bristol-Myers Squibb: At the Forefront of Immuno-Oncology Science & Innovation
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 20 types of cancers with 11 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 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. Continuedapproval 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 patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin. 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.
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 4.9% (13/263) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 3.4% (9/263) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=8).
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, among all patients (safety population [n=263]), adverse reactions leading to discontinuation (4.2%) or to dosing delays (23%) occurred. The most frequent serious adverse reactions reported in ≥1% of patients were infusion-related reaction, pneumonia, pleural effusion, pyrexia, rash and pneumonitis. Ten patients died from causes other than disease progression, including 6 who died from complications of allogeneic HSCT. Serious adverse reactions occurred in 21% of patients in the safety population (n=263) and 27% of patients in the subset of patients evaluated for efficacy (efficacy population [n=95]). 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 infections, and sepsis.
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, among all patients (safety population [n=263]) and the subset of patients in the efficacy population (n=95), respectively, the most common adverse reactions (≥20%) were fatigue (32% and 43%), upper respiratory tract infection (28% and 48%), pyrexia (24% and 35%), diarrhea (23% and 30%), and cough (22% and 35%). In the subset of patients in the efficacy population (n=95), the most common adverse reactions also included rash (31%), musculoskeletal pain (27%), pruritus (25%), nausea (23%), arthralgia (21%), and peripheral neuropathy (21%). 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 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.
Please see U.S. Full Prescribing Information, including Boxed WARNING regarding immune-mediated adverse reactions, for YERVOY.
Please see U.S. Full Prescribing Information for OPDIVO.
About the Bristol-Myers Squibb and Ono Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 2014, Ono and Bristol-Myers Squibb further expanded the companies' strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies - as single agents and combination regimens - for patients with cancer in Japan, South Korea and Taiwan.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that Opdivo will receive regulatory approval for the additional indication described herein. 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, 2015 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/20170119005235/en/
Source: Bristol-Myers Squibb Company
Read more: http://www.nasdaq.com/press-release/opdivo-nivolumab-demonstrated-efficacy-and-improved-survival-in-patients-with-previously-treated-20170119-00697#ixzz4WDTPsCZO
Why Bristol-Myers Squibb May Be a Merger Target Soon
The $101 billion market cap pharma could be put in play or targeted by an activist investor soon.
Ronald Orol Ronald Orol Follow Jan 17, 2017 9:59 AM EST
Insurgent fund manager Jana Partners' Barry Rosenstein recently acquired a large stake in the New York-based pharmaceutical company, according to a person familiar with the situation. He noted that the investment, which is a top position for the fund, was disclosed privately to Rosenstein's investors in a risk report. The report, however, didn't provide any commentary on the position.
EDITOR'S NOTE: This article was originally published by The Deal, a sister publication of TheStreet that offers sophisticated insight and analysis on all types of deals, from inception to integration. Click here for a free trial.
Nevertheless, Jana Partners frequently has launched campaigns and proxy contests, suggesting that one could be forthcoming, especially considering that Rosenstein hasn't initiated a new campaign in several months. According to FactSet, Jana Partners has threatened proxy contests at nine companies, engaged in director-election battles at seven companies and launched 38 campaigns overall since 2001.
All that suggests Rosenstein, an early employer of the activist tactic, could launch a contest at Bristol-Myers to press for some strategic options, in advance of a Feb. 2 deadline to nominate dissident director candidates for the company's 2017 annual meeting, expected in May.
There are a wide variety of strategic options available to Rosenstein and his team should they decide to agitate publicly or privately.
Steve Chesney, analyst at Atlantic Equities, said Rosenstein or another activist fund could take issue with what he sees as Bristol-Myers 's over-concentrated portfolio and its over-focus on one drug, blockbuster cancer therapy Opdivo. He suggested the company could be pressed to make acquisitions or invest more heavily in business development so it can become more diversified.
"Bristol is highly dependent on the outlook for one drug, Opdivo," Chesney said. "To support its revenue base, given the risk of competition in the immuno-oncology space, the prudent strategy would be to expand by acquisitions or alliances and partnerships with mid-stage or later-stage therapeutic development candidates."
Chesney estimates that roughly 30% of Bristol's 2020 revenue base, unless changes are made, will be driven by Opdivo.
Kurt Kemper, analyst at Hillard Lyons, agrees. He notes Bristol-Myers has said it is seeking to maintain a diversified portfolio within and outside of the immune-oncology space as part of its key strategies going forward. Nevertheless, Kemper suggests that Bristol-Myers should consider diversifying through acquisitions to help reduce its risk profile, given its heavy reliance on Opdivo.
He added that the drug company could make smaller acquisitions in the immuno-oncology space or even a larger transformative type deal outside of that space.
"We believe success in diversification outside of immuno-oncology is important for the company's risk profile, given the increasing competitiveness in the area," Kemper said.
Activists often pressure companies to be sold too. As a result, Jana Partners or another activist also could pressure Bristol to be acquired by another drug company. The pharmaceutical space is expected to see high levels of M&A activity in 2017, especially with the election of Donald Trump clearing away a lot of the regulatory hurdles to mega-drug sector M&A.
David Katz, founder of $760 million value investment firm $760 million Matrix Asset Advisors, said he expects a lot of M&A in the drug company and health care space in 2017. Katz, who is a contributor to Real Money, noted Pfizer (PFE) , Merck (MRK) , Johnson & Johnson (JNJ) or Novartis (NVS) are all capable of acquiring Bristol-Myers. He added that Bristol-Myers's large immune-oncology drug portfolio, led by Opdivo, could make it an attractive candidate to any of the largest global pharmaceutical companies. "There are only a few companies big enough that would be capable of making an acquisition of Bristol," he said.
Last week, for instance, Pfizer CFO Frank D'Amelio told a J.P. Morgan Healthcare conference that he expects more tuck-in and bolt-on acquisitions for the overall industry, adding that he thought large-scale M&A was possible.
Chesney also acknowledged that there has been "persistent chatter, given some of the excitement around the world of immuno-oncology," that Bristol-Myers Squibb could become a target for acquisition.
However, he suggested that the most capable buyers may not be interested. Johnson & Johnson hasn't pursued large scale commercial transactions in the pharmaceutical space and is already quite diversified in with operations involving drugs, medical devices and consumer products. He added that Johnson & Johnson is more focused on make smaller development stage asset acquisitions, suggesting it wouldn't want to make the kind of transformative acquisition a Bristol purchase would entail.
Chesney added that he thought it was unlikely that Merck, the closest competitor to Bristol in the oncology business, would have any interest, largely because the two companies already overlap significantly.
The most widely speculated potential buyer for Bristol-Myers is Pfizer - many analysts and investors contend that the New York based company would see more of a benefit in acquiring Bristol.
Chesney contends that while Pfizer has clearly expressed interest in similar assets in the past, its willingness to enter into a significant transaction for Bristol-Myers could be limited by the shifting sands in the immuno-oncology space as well as Pfizer's own efforts to develop an in-house program, including a partnership with German-based Merck KGaA.
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https://www.thestreet.com/story/13955786/1/why-bristol-myers-squibb-may-be-a-merger-target-soon.html
BMY
Rumors about leaked data, but the tangible likely reason for the pop:
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Details of Maxim Group Buy Rating on AEterna Zentaris (USA) (AEZS)
Posted by Eamon Howard | Jan 17, 2017
AEterna Zentaris (USA) (AEZS) was Reiterated by Maxim Group to “Buy” according to the research note released today. The brokerage firm has raised the Price Target to $ 10 from a previous price target of $7 . Maxim Group advised their investors in a research report released on Jan 17, 2017.
AEterna Zentaris (USA)
AEterna Zentaris (USA) opened for trading at $2.5 and hit $2.6 on the upside on Friday, eventually ending the session at $2.55, with a gain of 4.08% or 0.1 points. The heightened volatility saw the trading volume jump to 1,92,727 shares. Company has a market cap of $30 M.
Aeterna Zentaris Inc. is a Canada-based specialty biopharmaceutical company engaged in developing treatments in oncology endocrinology and women’s health. The Company has three wholly owned direct and indirect subsidiaries: AEZS GmbH based in Frankfurt Germany Zentaris IVF GmbH a direct wholly owned subsidiary of AEZS Germany based in Frankfurt Germany and Aeterna Zentaris Inc. Its drug development efforts are focused on two compounds zoptarelin doxorubicin and Macrilen which are in clinical development and on two oncology compounds (an Erk inhibitor and Luteinizing Hormone-Releasing Hormone-disorazol Z product candidates) which are in pre-clinical development. Zoptarelin doxorubicin represents a hybrid molecule composed of a synthetic peptide carrier and a chemotherapy agent doxorubicin. Macrilen (macimorelin acetate) is an orally available peptidomimetic ghrelin receptor agonist that stimulates the secretion of growth hormone by binding to the ghrelin receptor.
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https://www.highlandmirror.com/details-of-maxim-group-buy-rating-on-aeterna-zentaris-usa-aezs/
(I have no shares)
AEZS
Back in @ $22.53.
A new Fool article (not the reason for buying, but interesting):
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Why Zoe's Kitchen and Habit Restaurants Inc Declined in 2016
Both fast-casual chains faced investor skepticism due to forces affecting many of their peers in the restaurant industry.
Asit Sharma (TMFfinosus) Jan 11, 2017 at 4:55PM
What happened
Stock in Zoe's Kitchen Inc (NYSE:ZOES) and Habit Restaurants Inc (NASDAQ:HABT) fell 14.3% and 25.2%, respectively, in 2016, according to data provided by S&P Global Market Intelligence .
So what
Both chains came under pressure from a trend that plagued the restaurant industry for the entire year: decreasing traffic counts. According to restaurant analytics firm TDn2K, same store sales for the restaurant industry declined 3% during the first 12 months of 2016, with traffic as the primary culprit.
A look at food price trends illuminates why visits to restaurants have dipped. The Bureau of Labor Statistics (BLS) reports that for the 12-month period ending in November 2016, the Consumer Price Index for All Urban Consumers (CPI-U) revealed an average decrease in "food at home" (grocery) prices of 2.2%, and a corresponding increase in "food away from home" (restaurant) prices of 2.3%.
This differential of lower grocery costs versus climbing menu prices has effectively created a headwind for the restaurant industry. The fast-casual sector, to which both Zoe's and Habit Restaurants belong, is more vulnerable to discretionary caution among consumers than the quick service sector, in which fast food restaurants regularly entice their core customers to return through value and dollar menus.
Softer traffic has certainly cut into Zoe's momentum. Through the first three quarters of 2016, Zoe's posted a comparable sales increase of 4.9% versus the same period in 2015, one percentage point below the 2015 gain over 2014 of 5.9%. And comps may be weakening further: In the third quarter of 2016, the company managed a comparables increase of just 2.4%, which consisted of a 0.5% decrease in traffic, offset by an average ticket price increase of 2.9%. This mirrors the CPI-U grocery/restaurant dynamics discussed above.
Habit Restaurants, or "The Habit" as it is fond of referring to itself, may also be on a weaker comps footing at the close of 2016. After comparables increases of 2% in Q1 2016, and 4% in Q2 2016, the burger chain posted only a 0.2% bump in Q3 2016. As in Zoe's case, menu price hikes of 2.6% were negated by a drop in traffic of 2.4%.
Now what
While Zoe's and The Habit certainly aren't the only restaurants to have experienced a stock decline in 2016 due to investor pessimism over deteriorating customer visits, the companies are two of the higher profile fast-casual chains, both having debuted on the public markets within months of each other in 2014. As investors regard each as having growth potential that well exceeds the fast-casual sector as a whole, it's incumbent for them to show reinvigorated comps in 2017.
What should have been an acceptable alternative to comps growth really didn't impress investors last year. While we still will need to see final numbers when each company reports on its fourth quarter of 2016 in February, it's safe to say that both organizations will have expanded their store bases by roughly 25% in 2016. Still, this impressive pace of new store openings did little to support either company's stock price over the last 12 months.
Zoe's plan for improving comparables involves meals served outside its restaurants. The franchise is proving a popular Mediterranean-style, healthy option for catered business meals, and company management has signaled its intent to play to this strength in 2017. Zoe's has also started experimenting with small order meal delivery, and recently completed a 30 store test of family and single meal delivery with a third party. With a promising catering and delivery revenue stream, Zoe's may be able to weather some in-house traffic deterioration and still boost its comps in the coming quarters.
The Habit has taken a different tack to lifting traffic, which consists of introducing frequent, premium limited time offerings (LTOs), to build comps based on recurring customer visits and price increases. In the company's most recent earnings conference call, CEO Russ Bendel singled out a well-received strawberry balsamic chicken salad selling for $7.50 as the type of item that drives traffic and commands a higher price point. The Habit also intends to step up the use of technology in 2017, leaning on "targeted digital strategies" to complement its LTO innovation.
Regardless of approach, Zoe's and The Habit will have to execute with purpose in 2017, as they're up against larger macroeconomic trends that won't be easy to surmount. Investors looking for performance clues on either chain may want to pay more attention than usual to the government's monthly CPI press releases this year.
Asit Sharma has no position in any stocks mentioned. The Motley Fool owns shares of and recommends Zoe's Kitchen. The Motley Fool has a disclosure policy.
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http://www.fool.com/investing/2017/01/11/why-zoes-kitchen-and-the-habit-restaurants-decline.aspx?source=yahoo-2-news&utm_campaign=article&utm_medium=feed&utm_source=yahoo-2-news
ZOES
HEALTH NEWS | Wed Jan 11, 2017 | 9:35am GMT
Merck steals march on rivals in lung cancer drug combo race
By Bill Berkrot and Ben Hirschler
Merck & Co has pulled ahead of rivals in the race to combine immunotherapy with other drugs as a treatment for lung cancer, potentially giving it a major lift in the battle for the largest cancer market.
U.S. regulators have agreed to a speedy review of Merck's application to combine its immune system-boosting drug Keytruda with chemotherapy as an initial therapy for advanced lung cancer, the U.S. drugmaker said.
Shares in AstraZeneca, which is developing a dual-immunotherapy approach, fell around 1 percent in early trade on Wednesday, while Roche, which is looking to add chemotherapy like Merck, slipped 0.6 percent.
Merck said the U.S. Food and Drug Administration (FDA) would decide by May 10 whether to approve its Keytruda combination treatment, sending the company's stock more than 3 percent higher in after-hours trading.
Bristol-Myers Squibb is also working on an immunotherapy-based combination approach for lung cancer.
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http://uk.reuters.com/article/us-merck-co-cancer-idUKKBN14U2T5
Reason for the slip?
BMY
Transcript from JPMorgan:
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Bristol-Myers Squibb (BMY) Presents at JPMorgan Healthcare Conference (Transcript)
Jan. 10, 2017 3:17 PM ET| About: Bristol-Myers Squibb Company (BMY)
Bristol-Myers Squibb Company (NYSE:BMY)
JPMorgan Healthcare Conference Call
January 10, 2017, 12:30 P.M. ET
Executives
Giovanni Caforio - Chief Executive Officer
Analysts
Chris Schott - J.P. Morgan
Chris Schott
Good morning everybody. I’m Chris Schott, Pharmaceutical Analyst at J.P. Morgan. I’m very pleased to be introducing Bristol-Myers Squibb this morning. From Bristol, we have Giovanni Caforio, the company’s CEO.
With that, I’ll turn it over to Giovanni.
Giovanni Caforio
Good morning everyone. Thank you, Chris. It’s great to be here again at J.P. Morgan. I like to give you an update of where we are as a company. It’s clearly a very, very important time for us at Bristol-Myers Squibb and I look forward to the opportunity to review that with you. This is our forward-looking information.
And let me start my presentation by showing the slide that I believe may be familiar to many of you. And the objective of this slide is just to remind everyone that the company since 2007 has been very disciplined in executing against our strategy, and many of the principles of our BioPharma strategy are listed and highlighted on this slide.
When we think about who we are today, Bristol-Myers Squibb clearly is a differentiated and diversified BioPharma company. I like to think about our company, thinking about the portfolio, we have a very young portfolio of medicines in areas of very high unmet medical need that have transformative potential and importantly many of those are just the beginning of their life cycle and clearly can contribute in very significant ways to our growth as a company.
The second point I like to make is that our R&D organization clearly has been differentiated and played a very important role in the execution of the transformation of the company because of high productivity, the ability to deliver truly innovative medicines, but also because of our decision to really focus on how you can think about external innovation and internal innovation together as very complimentary for the company.
And so with a very, very productive R&D organization at the same time, we've also focused on business development, and this combined approach we believe is very differentiated and clearly has contributed to the transformation of our portfolio.
The third point relates to the fact that over the last two years as we've had the opportunity to launch multiple products globally, our commercial infrastructure has been scaled up, and today it is actually uniquely leveraged for the growth that is potentially ahead of us. You will remember this slide on BioPharma, we continue to be focused on leveraging the best of both.
And so when we look at our commercial execution, the ability to execute globally, it’s a very key priority for us. Similarly, we have financial strength and flexibility that enables us to execute by investing against our highest priorities, but at the same time we are continuing to challenge ourselves, evolve our operating model, and look for speed and agility in everything we do.
So, 2016 was a very important year for the company - some of you may remember a year ago, I presented a slide with our priorities for 2016, and I like to give an update of how we've executed against those priorities. Beginning with our operating performance, 2016 promises to be an extraordinary year for us, from a financial perspective and execution perspective, commercially.
Obviously, we've not communicated the results of our full-year yet, but when you look at our first nine months top line sales for the company grew 16%, and that was driven by very strong performance across our portfolio, it was true for our Immuno-Oncology portfolio which grew in the U.S. and internationally steadily during the year.
It was also true for a key growth driver for the company Eliquis, but also when you look at products that have growth potential, but have been in the market for longer such as Orencia and Sprycel, overall our business grew very, very well strongly in terms of sales growth, but also in terms of market share performance globally.
That resulted in a guidance, which we provided in October for 2016 that calls for our earnings per share growth in 2016 to be in the range of 40%, which obviously is strong leverage and a result that I am and we are all very pleased with. Obviously, one of our priorities, the core of our strategy and the number one priority is the focus on Immuno-Oncology.
I am sure you are all familiar with the fact that one of the disappointments of 2016 was the negative result of our monotherapy Phase 3 study in first line non-small-cell lung cancer, study 26. We've had a lot of discussions about that study, it clearly is disappointing that we were not able to offer a monotherapy option over 70% of newly diagnosed patients with lung cancer, but I will give you my perspective of how we are progressing our strategy and executing in a couple of slides.
I must say that beyond that event, it was another very strong year for us in Immuno-Oncology and it continued to be marked by clinical progress with study stops and good overall survival data that was the case for example in head and neck cancer. We continued to make progress from a regulatory perspective in our label for Obdivo broaden further in the U.S.; and also we saw significant regulatory approvals in the European Union and Japan to basically bring the full set of data we have to labels globally.
We look at this slide very often. I think that this is an area of science that is evolving at an unprecedented speed and I am very pleased that actually when you look at the number of indications we've added to the label of Obdivo in the last two years is really unprecedented and it was only achieved by some other products in oncology in a much, much longer time frame.
So science continues to move fast and we are leading the evolution of Immuno-Oncology in many different ways. Beyond the R&D space, let me just tell you about our commercial performance, you may also remember, I showed a similar slide last year and this year as well when you look at our commercial performance in the U.S. it was very strong.
Yervoy started growing again because of the adoption of the combination regimen in melanoma. Obdivo continued a very solid uptake across all tumor types and you can see here our competitive performance in 2016. Obviously, when we discuss 2017, we do expect that to be impacted by competitive dynamics that in the short term, particularly this year will impact the lung cancer market, but overall 2016 performance commercially was very, very strong.
Let me now move to Eliquis, and I am very pleased with the performance of Eliquis. We are working extremely well in support of a product that has a very differentiated profile. Some of you may remember that with Eliquis we have a very disciplined and somewhat sequential approach. We focus in every market on cardiology first.
So this is an example of our performance in the U.S. where we now have established the leadership of Eliquis in cardiology in terms of the TRx, so total prescriptions and not only limited to the NOAC market, but also including warfarin where we have actually passed warfarin in TRx’s in cardiology in the U.S.
And this is actually representative of what is happening in large markets like Japan and Germany where we continue to see really strong momentum in cardiology. In fact, in the US for example, we have become the number one [indiscernible] in institutional setting and I think that’s clearly very important in this area.
We are also making very good progress in the total market, which includes primary care physicians, and working very effectively with Pfizer on this segment of the market. And here you see, in the U.S. our new to brand share lead over Xarelto is now over about 10 percentage points, and here as well we are beginning to see very, very strong momentum.
That's actually really important because the next phase of growth for Eliquis comes from gaining TRx, leadership in the total market, we think we are relatively close to achieving that, but then obviously our objective becomes to begin to really broaden the market because there are a number of patients still receiving warfarin and that are clearly a large number of patients still being treated sub optimally overall.
Let me close the review on 2016. I tell you that I'm also pleased with what we accomplished from a business development perspective. I'm actually really happy about some elements of the slide, first of all, its breadth. We were able to sign and close some really interesting and important partnership with academia, with biotech, with larger companies, there is a global scope to our business development activity and clearly it spans between oncology and the other areas that are in focus for us.
So let me now move to 2017 and not surprisingly we will remain very disciplined and focus on very similar priorities for 2017, and this year as well clearly in Immuno-Oncology is at the centre. So, when I think about our Immuno-Oncology business, there are really three components to them, and I see them having very, very different dynamics in 2017.
First of all, it’s our U.S. lung business and we acknowledge that it would be a very competitive environment and we will be impacted this year by the entrance of new agents in lung cancer. We do expect that to be a market that transitions very rapidly and again in the next slide I’ll give you some insights about that.
Outside of lung in the U.S., we are seeing continued strong momentum for Obdivo and Yervoy. Across all of the approved indications we are preparing for a potential launch in bladder and again the performance trends are very, very strong. And I do expect that this year the third leg, the third part of our Immuno-Oncology business, which is really our international business can be a key driver of growth for us.
We have been very successful last year in most markets in securing pricing our reimbursement for Obdivo and Yervoy and we are at the beginning of uptake curves that can look very similar to what we experienced when we launch those agents in the U.S.
Now, just to close there, maybe to remind all of you, we have provided preliminary guidance in October, which speaks through our confidence at Opdivo and Yervoy will grow globally and that we see that there is an opportunity for them to grow in the U.S. as well.
Now, let me go to lung cancer. We spoke about study 26, personally because of the data we have seen in the early stage and the promise of combinations, my perspective is that this market will transition very rapidly through the data readouts of 2017 and 2018 into a combination market.
We saw that happening in melanoma and we expect similar dynamics to drive the transformation of the luck lung cancer market in the U.S. and internationally. That’s where you get the most value in terms of clinical efficacy for patients and in a disease like lung cancer when data is available, we do expect that combinations will be adopted very, very rapidly.
We also believe that we are extremely well positioned in combination. It has been at the core of our strategy since the beginning. We did that in melanoma and we are very well positioned to do that in lung as well. Looking at our phase 3 program in lung, it clearly is very broad. We have ongoing phase 3, programs ongoing where the I-O, I-O combo of Obdivo and Yervoy that’s clearly our priority, we have studies ongoing across all levels of expression of PD-1.
We now have I-O chemo combos phase 3 ongoing, again across all levels of expression of PD-1, and also we are testing innovative strategies to combine our combination regimen with a short term cycle of chemotherapy because we believe it is interesting to understand whether what can address the needs of a small group of patients that progress very, very rapidly and need a very aggressive approach at the beginning.
So, looking at the totality of our ongoing trials, I’m very confident we’re doing the studies we need to do in order to support a rapid transition of the lung cancer market through combinations. Beyond lung cancer, our program continues to expand. Looking at the medium-term, we have 14 potential data readouts in the next 24 months in 10 tumor types that truly have the potential to broaden the label of Obdivo and Yervoy, and low we look forward to the readouts of many of those trials this year and into next year.
And then looking at the long term, our pipeline is clearly as strong or stronger than it’s ever been. Many of those programs are very early, all of them are extremely promising. You see here our approach to Immuno-Oncology where we have 10 compounds in the clinic, 10 medicines in the clinic being studied across 13 tumor types.
When you combine our pipeline of the Immuno-Oncology and oncology, we have close to 15 molecules going into the clinic. And so in the second part of this year into next year, we will begin to see data readouts that can lead to the rapid beginning of registrational progress. In fact, we already have we already have seen some data at the end of 2016 and there will be scientific presentations in the first part of this year as well.
Now let me move from oncology to the rest of the portfolio, obviously the focus for 2017 there is primarily to continue to support strong commercial performance for Eliquis, Orencia, and Sprycel, but we remain also very focused on advancing our early pipeline in the areas you see in this slide, which are the areas we've chosen as a focus for the company. Our pipeline in heart failure immunoscience fibrosis is early, but it is actually progressing very nicely.
Many of our programs are first-in-class programs. They have the potential to be best-in-class in all cases and they do address areas of high unmet medical need. This is an area we’ve not discussed extensively in our pipeline because those programs are relatively early and it is also an area where many data readouts from those that you see listed at phase 2 programs will happen later this year and into next year, and so I do expect that we will have a broader dialogue about some of them when we actually have data that leads to the beginning of registrational programs.
So, overall, when I look at our priorities with respect to marketed products and the pipeline, I think we have a very strong story with respect to short term growth prospects, medium term catalysts, and long-term growth potential for our pipeline.
Now, moving to a different topic, I mentioned at the beginning how we are constantly challenging the way we are organizing and allocating resources in the company. And obviously at the end of a very significant transformation period for us it was important to go back and really look at our infrastructure, and whether we are organized as a company in a way that enables us.
Number one, to maximize the allocation of resources to our highest priorities; and number two, move with speed and agility to remain very competitive. I think that’s very, very important for us to do. A company should never actually think you are done in transforming the way you do business and clearly for us at Bristol-Myers Squibb anticipating market change and evolving as a company has always been a very big priority.
Our objective in the last 12 months with my management team really has been to be very focused on every one of the five areas you see in this slide, and realign our organization in order to make sure that we are able to allocate resources to our highest priorities because we clearly have significant opportunity in every one of our programs.
The second one is that we become increasingly an even more agile and efficient. And that happens by organizing in a way that you can actually accelerate decision-making. I’m actually very pleased with the work we're doing. It is generating really important results already.
One good example, I would like to mention is, the announcement we made recently about the redesign of our research footprint in the U.S. where we were able to evolve from a larger number of research sites to a much more concentrated footprint, at the same time we took that opportunity to bring our research centers closer to a areas of academic expertise and knowledge and talent, and decided to create a research centre in Cambridge, increased significantly the scope and size of our organization here in California.
And I think it’s a really good example of how one can realign an organization, obtain significant efficiencies, but at the same time upgrade the capabilities you need in order to be successful. And so we are doing similar things across the five areas you see below and I’m very excited about what that will do to our company.
Financially, we remain extremely focused on creating value for shareholders. Our balance sheet is strong. We have clearly significant flexibility from a financial perspective to continue to invest and execute our strategy.
We did announce that through the evolution of our operating model, we believe we are able to maintain our OpEx roughly flat between now and 2020, but at the same time we are committed to increasing investment in R&D and continuing to make all of the right decisions in order to support the evolution of the pipeline and the growth of the portfolio. We remain committed to the dividend that’s clearly very important to us, particularly as our company continues to grow.
And finally as you also know, we have announced an expansion of our authorization for share repurchases, which gives us the right flexibility to continue to be opportunistically repurchasing shares. To close here at JPMorgan, let me just reiterate, business development is an absolute priority for the company.
I believe it is an area in which we have demonstrated our ability to execute very effectively, and I remain and we all remain very focused at Bristol-Myers Squibb at looking for the right opportunities that make sense for us strategically, meaning by that a focus on the therapeutic areas we have chosen scientifically because we do only want to invest in transformational medicines that can really make a difference for patients and obviously financially because we can and we must remain disciplined with the investments we make.
So, with that, let me just close and say I am very excited about our prospects for 2017. There is really good momentum in the company, clearly we operate in rapidly evolving markets from a science perspective, from a commercial perspective that requires us to be very, very focused on our key priorities, and I look forward to updating you over the course of 2017 on continued success at Bristol-Myers Squibb in executing our strategy. Thank you.
Question-and-Answer Session
Q -
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http://seekingalpha.com/article/4035741-bristol-myers-squibb-bmy-presents-jpmorgan-healthcare-conference-transcript?part=single
BMY
From the newly filed 8-K:
The entire document from company website:
http://ir.iderapharma.com/phoenix.zhtml?c=208904&p=irol-SECText&TEXT=aHR0cDovL2FwaS50ZW5rd2l6YXJkLmNvbS9maWxpbmcueG1sP2lwYWdlPTExMzE1MzM3JkRTRVE9MCZTRVE9MCZTUURFU0M9U0VDVElPTl9FTlRJUkUmc3Vic2lkPTU3
IDRA
Now down on rumor of trial suspension:
https://clinicaltrials.gov/ct2/show/NCT02500797?recr=Suspended&lup_s=01%2F01%2F2017&rank=5
This study has suspended participant recruitment.
(Per Complete Sheet, Pre-registration limit reached)
Sponsor:
National Cancer Institute (NCI)
Folks not reading the full data noted in red.
BMY
The Baker Bros are still believers. Got ~$10.5M worth of shares on 1-3-17 ($1.50). Can't believe how relentless the sellers have been at it the past few weeks.
https://www.sec.gov/Archives/edgar/data/861838/000163859917000048/xslF345X03/doc4_4456.xml
IDRA
Sorry didn't get back sooner. They had a fail on the Phase III. See the full text of the PR here:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=127629453
The big candle is not nearly as bad as could have been as the pps rose from the opening steadily all day although it dropped prior to closing much as you would expect.
AEZS
FWIW, both HACK and CIBR etfs are also up -- been eyeing them, but have no shares.
PANW
Yeh, just saw it - thanks!
Citron Research ?@CitronResearch 9m9 minutes ago
Watching the Senate hearings on Cybersecurity this morning leads Citron to believe that $PANW might be the 2017 market darling.
https://twitter.com/citronresearch?lang=en
Nothing like timing --not!
They also had an analyst upgrade today.
PANW
Sold @ $131.50. Remained in too long. Remains bullish and will get back in soon. Tends to have huge daily swings:
Beta 1.63
Read more: http://www.nasdaq.com/symbol/panw#ixzz4UuaRjCE9
PANW
Probably means nothing, but they no longer have a Fact Sheet (have had one for over 5 years). Was there yesterday because I had checked -- gone today. From iBox:
"Investor Fact Sheet: (November, 2016)
http://ir.aezsinc.com/sites/aezsinc.investorhq.businesswire.com/files/doc_library/file/Fact_sheet_MASTER_November2016.pdf"
Becoming less transparent?
AEZS
Not sure if rumor or they are creating a rumor:
___________________________________________________
Bristol-Myers Squibb (BMY) Stock: Here’s Why It’s Up
InvestingBiotechBreaking NewsJan 5, 2017 0 137
Bristol-Myers Squibb Co (NYSE: BMY)
Bristol-Myers Squibb is off to what looks like it may be an incredible day in the market today. Early on, the stock looked like it was headed for a normal day in the session. However, minutes ago, we started to see a spike in value. Below, we'll talk about what we're seeing, why, and what we'll be watching with regard to BMY ahead.
What We're Seeing From BMY
As mentioned above, Bristol-Myers Squibb was off to a relatively normal day in the market early on. However, the normal movement didn't last long. Minutes ago, we started to see a spike in value on the stock. Currently (10:00), BMY is trading at $59.78 per share after a gain of $0.64 per share or 1.08% thus far today.
Why The Stock Is Headed Up
As is almost always the case, our partners at Trade Ideas were the first to alert us of the upward movement on BMY. When they did, the CNA Finance team started digging to see exactly what was causing the movement. In this particular case, we were able to dig up the story relatively quickly. It seems as though a social rumor is causing the movement.
At the moment, if you search your favorite social network for Bristol-Myers Squibb, chances are that you'll see the rumor too. The rumor is that Jana has increased its stake in the company. Now, keep in mind that this has not been confirmed on either side. Nonetheless, if this is indeed the case, it's good news.
What We'll Be Watching Ahead
Moving forward, the CNA Finance team will be keeping a close eye on BMY. In particular, we're interested in seeing whether or not there is any validity to this rumor. Nonetheless, we'll keep an eye on the news and bring it to you as it breaks!
___________________________________________
http://cnafinance.com/bristol-myers-squibb-bmy-stock-heres-why-its-up/13103
BMY
Suppose the time of the information had something to do with it (2:15 pm). The drug symbols (LABU my choice for gauging) were already bullish and they retained approx the same level till close. Also it was probably unnoticed unless one follows The Fly and/or Politico. Didn't cause me to sell but it could be a harbinger. Trump has already expressed concern about drug pricing and later in the day Biden was quoted as concerned about pricing:
"Now, Biden said, he is getting strong encouragement from throughout the cancer community to grapple with the pricing issue. “The researchers, the insurers, all of the major cancer centers .?.?. want me to pursue it.” He added that Greg Simon, executive director of the White House Moonshot Task Force, recently met with the pharmaceutical company officials. “They all realize they have a problem,” the vice president said.
In December, President-elect Donald Trump also spoke out against pharmaceutical-industry price hikes. “I'm going to bring down drug prices,” he told Time magazine."
__________________________________________
https://www.washingtonpost.com/news/to-your-health/wp/2017/01/04/biden-to-tackle-cancer-drug-prices-as-part-of-post-white-house-moonshot-work/?postshare=2401483574234825&tid=ss_tw&utm_term=.3aa478a6880c
Is BMY among those who should be targeted for abusive pricing? I wasn't aware it has been.
BMY
Aeterna Zentaris doubles down on macimorelin PhIII, and loses
by john carroll
January 4, 2017 06:21 PM EST
Updated: January 5, 2017 07:51 AM
Aeterna Zentaris CEO David Dodd
Two years after the FDA handed Aeterna Zentaris a stinging rejection for its proposal to market macimorelin for the evaluation of growth hormone deficiency in adults, the biotech says the drug flunked another late-stage study.
Just as Aeterna Zentaris witnessed in late 2014, its stock $AEZS cratered, dropping by about 50% in after-market trading.
The FDA sent Aeterna Zentaris back to the clinical drawing board after pointing out that macimorelin had failed to hit the primary endpoint. Aeterna Zentaris moved from Canada down to Charleston, SC more than two years ago, promising to create 60 jobs.
There’s no immediate word on next-steps at the biotech for this two-time failure, but CEO David Dodd has a backup plan. In a statement, he said:
While we are disappointed regarding the outcome of this trial, we will now re-direct our resources to the completion of the on-going Phase 3 clinical trial of Zoptrex in women with advanced, recurrent or metastatic endometrial cancer who have progressed and who have received one chemotherapeutic regimen with platinum and taxane (either as adjuvant or first-line treatment).
________________________________________
https://endpts.com/aeterna-zentaris-doubles-down-on-macimorelin-phiii-and-loses/
AEZS
Aeterna Zentaris Announces Top-Line Results of Confirmatory Phase 3 Trial of Macrilen™
Date : 01/04/2017 @ 5:15PM
Source : Business Wire
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”) today announced that the confirmatory Phase 3 clinical trial of Macrilen™ (macimorelin) failed to achieve its objective of validating a single oral dose of macimorelin for the evaluation of growth hormone deficiency in adults (“AGHD”), using the insulin tolerance test (the “ITT”) as a comparator. The Company is evaluating the outcome of the trial and will determine in the near future whether it will continue with the development of Macrilen™.
Dr. Richard Sachse, the Company’s Chief Scientific Officer, stated, “We are, of course, very disappointed about the outcome of the trial. Based on an analysis of top-line data, macimorelin did not achieve equivalence to the ITT as a means of diagnosing AGHD. Under the study protocol, the evaluation of AGHD with Macrilen™ would be considered successful, if the lower bound of the two-sided 95% confidence interval for the primary efficacy variables was 75% or higher for “percent negative agreement” with the ITT, and 70% or higher for the “percent positive agreement” with the ITT. While the estimated percent negative agreement met the success criteria, the estimated percent positive agreement did not reach the criteria for a successful outcome. Therefore, the results did not meet the pre-defined equivalence criteria which required success for both the percent negative agreement and the percent positive agreement. After a thorough internal review and understanding of this data, the Company will decide upon the appropriate future course of action with respect to macimorelin.”
David A. Dodd, the President and Chief Executive Officer of the Company, stated, “While we are disappointed regarding the outcome of this trial, we will now re-direct our resources to the completion of the on-going Phase 3 clinical trial of Zoptrex™ in women with advanced, recurrent or metastatic endometrial cancer who have progressed and who have received one chemotherapeutic regimen with platinum and taxane (either as adjuvant or first-line treatment). Zoptrex™ represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. It is the first drug in advanced clinical development that is considered to direct the chemotherapy agent specifically to LHRH-receptor expressing tumors, which then could result in a targeted treatment with less damage to healthy tissue. Potential benefits of this targeted approach include better efficacy and a more favorable safety profile with lower incidence and severity of side effects as compared to doxorubicin alone. We look forward to reporting the results of this trial in the very near future.”
Conference Call
The Company will host a conference call to discuss the results of the confirmatory Phase 3 clinical study of Macrilen™ on Thursday, January 5, 2017, at 8:30AM, Eastern Time. Participants may access the conference call by using the following number: 201-689-8029, Confirmation 13651438.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing Zoptrex™, a novel cytotoxic compound. We intend to license out certain commercial rights to Zoptrex™ to licensees in territories where such out-licensing would enable us to ensure development, registration and launch of the product. Our goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of our product portfolio, achieving successful commercial presence and growth, while consistently delivering value to our shareholders, employees and the medical providers and patients who will benefit from our products. For more information, visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the US Securities Litigation Reform Act of 1995. Forward-looking statements may include, but are not limited to statements preceded by, followed by, or that include the words “expects,” “believes,” “intends,” “anticipates,” and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects and clinical trials, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the rejection or non-acceptance of any new drug application by one or more regulatory authorities and, more generally, uncertainties related to the regulatory process, the ability of the Company to efficiently commercialize one or more of its products or product candidates, the degree of market acceptance once our products are approved for commercialization, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, the ability to protect our intellectual property, the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and US securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except if required to do so.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170104006480/en/
Aeterna Zentaris Inc.
Philip A. Theodore, 843-900-3223
Senior Vice President
ir@aezsinc.com
____________________________________________
AEZS
From The Fly:
"Dems to force drug price votes in fight over 'repeal resolution,' Politico says Senate Democrats plan to introduce a number of amendments to the upcoming budget resolution -- designed to facilitate a repeal of Obamacare -- including measures targeting drug pricing, reports Politico, citing sources. Al Franken and Amy Klobuchar are among Senators planning to introduce such amendments, spokespeople told the publication. The pricing measures could include a vote on drug importation, which Politico argues "stands a chance at making it through the upper chamber" given the concept's popularity among some Republicans. One lobbyist told the publication that Democrats are "eager" to continue to pressure Donald Trump on drug pricing. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Mylan (MYL), Celgene (CELG), AbbVie (ABBV), Amgen (AMGN), Valeant (VRX) and Allergan (AGN). Reference Link"
Read more at:
http://thefly.com/landingPageNews.php?id=2483929
BMY
Bristol-Myers Squibb Company (BMY) Ex-Dividend Date Scheduled for January 04, 2017
January 03, 2017, 09:00:04 AM EDT By NASDAQ.com News
Bristol-Myers Squibb Company ( BMY ) will begin trading ex-dividend on January 04, 2017. A cash dividend payment of $0.39 per share is scheduled to be paid on February 01, 2017. Shareholders who purchased BMY prior to the ex-dividend date are eligible for the cash dividend payment. This represents an 2.63% increase over prior dividend payment.
The previous trading day's last sale of BMY was $58.9, representing a -23.63% decrease from the 52 week high of $77.12 and a 20.13% increase over the 52 week low of $49.03.
BMY is a part of the Health Care sector, which includes companies such as Johnson & Johnson ( JNJ ) and Pfizer, Inc. ( PFE ). BMY's current earnings per share, an indicator of a company's profitability, is $2.04. Zacks Investment Research reports BMY's forecasted earnings growth in 2016 as 42.54%, compared to an industry average of 4.6%.
Read more: http://www.nasdaq.com/article/BMY-2017-01-03#ixzz4Uiic2Imr
_________________________________________
BMY
Bristol-Myers Is Poised To Break Out In 2017
Dec. 27, 2016 4:52 AM ET|13 comments | About: Bristol-Myers Squibb Company (BMY), Includes: AMGN, GILD, LLY, MJN, MRK, PFE, XLV
Alexander J. Poulos Alexander J. PoulosPremium Research »Follow(4,285 followers)
Summary
Bristol-Myers has managed to frustrate numerous investors this year.
Expectations were running ahead of themselves as BMY was poised to garner a first line monotherapy designation for Opdivo in NSCLC.
The stock price collapsed upon a notable clinical failure.
As detailed below, BMY offers a compelling value in the pharma/biotech space.
omitted
As 2016 draws to a close, the year will go down a rousing success for many investors. Multiple industries have posted stellar gains, yet I have often found last year's laggards often become the next year's winners. The article below will update my bullish stance on Bristol-Myers Squibb (NYSE:BMY) as the calendar flips to 2017.
The Year to Forget
BMY started the year off with a bang as its lead oncology compound seemed poised to dominate the oncology space. Bullish pieces flowed like water as analysts tripped over themselves to issue higher and higher buy prices centered around the continued clinical progress registered by Opdivo.
The second leg down occurred when results came in from the Checkmate-026 trial for the use of Opdivo as first-line monotherapy for Non-small Cell Lung Cancer, one of the largest oncology markets. Opdivo did not meet its statistical endpoint shocking most and leading to heavy selling pressure. It remains my belief from the onset that first-line therapy would revolve around the use of multiple agents to yield optimal results. Unfortunately for BMY bulls, Merck (NYSE:MRK) Keytruda now owns the first line monotherapy market. Undaunted, BMY has multiple shots at its goal with its in-house combo of Yervoy in addition to licensing deals with other players in the field.
omitted
Source
The optimal configuration for BMY would be for superior results to come from in-house controlled Opdivo/Yervoy yet BMY has wisely hedged its bets with partnerships.
2017 Guidance
omitted
BMY's initial 2017 guidance masks the real power of its Oncology franchise as BMY awaits further data to power revenue growth. True earnings power is hidden by BMY's high R&D spend as they are funding multiple clinical trials to ensure the broadest label possible for its Oncology franchise. As the products mature, the need for a heightened level of R&D will diminish thus providing higher profits to the bottom line via a reduction in spending. The key here is sustained revenue growth, with BMY possessing the most favorable revenue growth profile for the next five years of the major pharma players.
Role of the Dividend
BMY is often associated with a dividend growth entity, yet the profile of the company has changed as they have spun-off their non-core products such as Mead Johnson (NYSE:MJN). BMY has morphed more into a biotech outfit and should be viewed through a similar lens as Gilead Sciences (NASDAQ:GILD) and Amgen (NASDAQ:AMGN) instead of more diversified entities such as Eli Lilly (NYSE:LLY) and Pfizer (NYSE:PFE).
BMY does pay a dividend of 39 cents per quarter of a yield north of 2.5% yet dividend growth the next few years will remain anemic as BMY priority remains building out its oncology offerings. BMY should be viewed as a growth play with an income component versus a dividend growth play.
Management indicated their intention to return an additional $3 billion to shareholders via share repurchases. I have no doubt this is in response to the steep fall in the stock price; I subscribe to management's view that the oncology pipeline in its entirety offers significant value.
Technical Overview
[color=red](omitted)[/color]
The share price has recovered from the violent sell-off in October after the full details of the failed Checkmate trial were released. I posted a recent article on BMY discussing the merits of the company's stock only to be blindsided with a violent sell-off as the full results of the failed trial were revealed. Fortunately, for the BMY longs patience has been rewarded as the stock has come back closing the downward gap formed in early October. In hindsight, the sell-off in October reeks of capitulation selling as funds headed for the exits with the US presidential election looming.
The entire sector received a "Trump Bounce," yet unlike its pharma/biotech brethren BMY continues its elongated basing pattern as it steadily pushed higher. BMY has closed notably above the level witnessed post-election indicating that the move has nothing to do with short covering and is more indicative of value players gaining exposure for a leg up heading into 2017.
Source
I would not be at all surprised if the most notable laggard for 2016, the healthcare sector, led the charge in 2017 as investors rediscover the virtues of the industry. Healthcare underperformance is 2016 is quite unusual, yet by adopting a longer term view illustrates the staying power of the sector. The sector has returned 10% annualized based on the performance of the Health Care SPDR (NYSEARCA:XLV). I am using the XLV as a proxy. The only sectors that have performed better are the Consumer Discretionary at 10.28% and Consumer Staples at 10.55%. A bit of mean reversion is in order here: the XLV's dreadful underperformance in 2016 bodes well for a snap back in 2017.
Conclusion
As the calendar flips to 2017, I suspect the healthcare sector as a whole will begin to recoup the ground lost in 2016. At its current quote, the healthcare space is now undervalued with multiple names trading at below market multiples in this typically defensive sector. I would not be at all surprised if "hot money" leaves some of the areas that have experienced a huge run in 2016 and reverts to those that have underperformed. BMY exhibits the classic signs of an equity in an unloved sector that seems poised to break out substantially higher; I would not be at all surprised if BMY tested the open gap at roughly $64 early in 2017 especially if it can break above the resistance of its 200 day moving average at $62.92. I would like to thank you for reading; I look forward to your comments.
Investors are always reminded that before making any investment, you should do your proper due diligence on any name directly or indirectly mentioned in this article. Investors should also consider seeking advice from a broker or financial adviser before making any investment decisions. Any material in this article should be regarded as general information, and not relied on as a formal investment recommendation.
Disclosure: I am/we are long BMY, GILD, PFE.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Additional disclosure: Long BMY via puts and calls.
http://seekingalpha.com/article/4032799-bristol-myers-poised-break-2017?app=1&auth_param=udil:1c64eek:a798e01ec50ad0ad79536eb606d10540&uprof=46
__________________________________________
Many charts/graphs not included.
BMY
Great call!
(I have no shares)
AEZS
Palo Alto Gets Great Marks, FireEye Deteriorates, in Piper Survey
December 21, 2016, 10:51 A.M. ET
By Tiernan Ray
Piper Jaffray’s Andrew Nowinski this morning offers up to clients a summary of a meeting he assembled last week between investors and security technology consultants and resellers, the substance of which was encouraging for vendors Palo Alto Networks (PANW), Symantec (SYMC), and Proofpoint (PFPT), but discouraging for FireEye (FEYE)
On Palo Alto, especially, he’s encouraged by the outlook for ’17:
Resellers of Palo Alto were very bullish on the outlook for 2017, as they said deals were pushed out to 2017 due to a lack of operating expense budget needed for the subscription components of deals. We note that Palo Alto has taken over the #1 market share position as of 3Q16 and the stock is trading at the cheapest valuation in the entire security universe (9.1x EV/CY18E FCF).
Nowinski notes data from researcher IDC that shows “Palo Alto has taken over the #1 position in the security market with 17.1% share.”
Symantec was another one with good feedback:
Resellers were also very positive on Symantec, stating they are impressed with the changes the new management team has made. Resellers said Symantec has done a great job rationalizing their portfolio and cited the new SEP14, which is Symantec’s new endpoint product that was launched in November. They also said the Proxy market is robust, with strong demand for Blue Coat.
So was Proofpoint:
The feedback from resellers at the event on Proofpoint was also positive. Resellers said demand for Proofpoint is “white hot,” which we believe is a combination of a lack of competition and the increasing prioritization for email security.
One that’s not getting such great feedback is FireEye:
Resellers said demand for FireEye has gotten worse and they are no longer leading with FireEye products for advanced threat protection. Most believe advanced threat protection is just a feature on a larger platform, though we would argue that FireEye has assembled a larger platform of integrated products. The company now has virtual/subscription-based versions of their products, including their flagship NX-series. We believe the new head of sales Bill Robbins has a lot of work ahead of him re-engaging key channel partners.
_________________________________________________
http://blogs.barrons.com/techtraderdaily/2016/12/21/palo-alto-gets-great-marks-fireeye-deteriorates-in-piper-survey/
Still in but the last 2 days haven't been great. A chance to buy more.
PANW
On the date that Dodd purportedly bought shares, AEZS released a pump video on YouTube:
Interesting chart, don't know about stocktwits charts, but do see they list Dodd as purchasing 15,000 shares @ 3.39 and 3.40 on the 6th. He got them at the exact low of the day. All the rest are options given by the company which unfortunately dilutes currently holder's value by over a half million shares. I wouldn't call 15,00 shares as significant insider buying! other than the fact that an AEZS insider is buying which they rarely do. What is puzzling to me is if the stocktwits data is true how is AEZS legally avoiding submitting a Form 4 for this transaction. Any clues?
AEZS has moved nicely the past 3 days.
AEZS
I see no insider buying:
https://www.marketbeat.com/stocks/NASDAQ/AEZS/
http://www.nasdaq.com/symbol/aezs/insider-trades
(I have no shares)
AEZS
Not invested in WLGC, but saw this:
___________________________________________________________
WordLogic enters into agreement with Innovation Licensing Services LLP to defend patent portfolio
VANCOUVER, Dec. 7, 2016 /CNW/ - WordLogic Corporation (OTCQB:WLGC), the global leader in predictive intelligence text input technology that creates patented solutions for mobiles, tablets and desktops has entered into an agreement with Innovation Licensing Services LLP out of Boynton Beach, Florida to address unauthorized use of the predictive text Patents owned by WordLogic Corporation.
Innovation Licensing Services has reviewed the WordLogic Patents and believes there are potentially hundreds of companies infringing on these Patents. A plan is in place to target specific industries including retail, automotive and technology companies in the first 90 days. WordLogic and Innovation Licensing Services have begun work to prioritize companies believed to be using predictive text technology covered by WordLogic Patents.
Innovation Licensing Services' management has over 30 years' experience helping companies defend their Patents and have been responsible for millions of dollars in licensing and court ordered settlements on behalf of their clients.
WordLogic Corporation (OTCQB: WLGC) owns a number of Patents regarding predictive text as well as some Patent Pending technologies. WordLogic will be taking a very firm and aggressive stance to protect their intellectual properties.
For more information, see the descriptive video of the patent-pending "Reach" advertising search engine and WordLogic technologies at www.wordlogic.com.
About WordLogic Corporation
WordLogic Corp. develops, markets, licenses and sells advanced predictive platform software designed to accelerate information discovery and text input. The Company's innovations operate on a wide variety of devices including smartphones, PCs, cell phones, Smart TV, media players, automotive navigational systems, infotainment and game consoles. The Company's intellectual property portfolio includes U.S. and European patents and numerous pending patent applications.
For more information about WordLogic Corporation, visit wordlogic.com.
To send a message via Twitter, contact us at www.twitter.com/wordlogiccorp or visit us on Facebook at www.facebook.com/wordlogiccorp.
WordLogic headquarters are located at 1130 West Pender Street, Suite 230, Vancouver, BC, Canada.
Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements and are subject to risks and uncertainties. See WordLogic's filings with the US Securities and Exchange Commission which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.
SOURCE WordLogic Corp.
__________________________________________________________
https://ceo.ca/@newswire/wordlogic-enters-into-agreement-with-innovation-licensing
WLGC