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Bristol Myers (NYSE: BMY) closed yesterday at $24.03. So far the stock has hit a 52-week low of $17.23 and 52-week high of $24.63. Bristol Myers stock has been showing support around 23.48 and resistance in the 24.76 range. Technical indicators for the stock are Bullish and S&P gives BMY a neutral 3 STAR (out ...(Click the story link or go to http://www.marketintelligencecenter.com for the full story)
The pharmaceutical landscape is rapidly changing as patents for some of the blockbuster drugs of the last decade near expiration and other players try to grab some of the remaining revenues before generic medications flood the market. AstraZeneca (AZN) announced Thursday morning that it has filed a New Drug Application with the FDA for its antiplatelet treatment ticagrelor. The drug is meant to treat major cardiac events in patients with acute coronary syndrome (ACS) a disease that affects 2.4 million Americans according to the American Heart Association.The drug works by keeping platelets in the blood from sticking together which ...
Theflyonthewall.com is Wall Street's specialist in breaking equity news. Veteran traders build a proprietary feed of news that's faster and more relevant than any other source. Try us for free and discover for yourself.
Bristol Myers (NYSE: BMY) closed yesterday at $24.52. So far the stock has hit a 52-week low of $17.23 and 52-week high of $24.63. Bristol Myers stock has been showing support around 23.87 and resistance in the 24.87 range. Technical indicators for the stock are Bullish and S&P gives BMY a neutral 3 STAR (out...(Click the story link or go to http://www.marketintelligencecenter.com for the full story)
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has set a new action date under the Prescription Drug User Fee Act for the review of the New Drug Application (NDA) for Exalgo™ (hydromorphone HCl extended-release) Tablets (CII), (Exalgo) of February 22, 2010.Antigenics Inc. (NASDAQ: AGEN) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has formally adopted a negative opinion on the marketing authorization application (MAA) for Oncophage (vitespen) as a treatment in earlier-stage, localized renal cell carcinoma (kidney cancer).Inovio Biomedical Corporation (NYSE Amex:INO), a leader in DNA vaccine design, development and delivery, announced today that a combination of its synthetic consensus H1N1, H2N2, H3N2, and H5N1 influenza vaccine candidates achieved protective antibody responses against several different influenza sub-types and strains in ferrets.Genta Incorporated (OTCBB: GETA.OB) announced preliminary results that show a high objective response rate in a pilot study of patients with advanced melanoma that incorporates the Company’s lead oncology product, Genasense® (oblimersen sodium) Injection, administered for the first time as a 1-hour high-dose intravenous (IV) infusion.POZEN Inc. (NASDAQ: POZN) announced today the start of enrollment for the phase 3 studies for PA32540. PA32540 is a fixed-dose combination of 325 mg of enteric coated aspirin and 40 mg of immediate release omeprazole, under investigation for use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers.Novavax, Inc. (Nasdaq: NVAX) today announced that it has priced an underwritten public offering of 6,800,000 shares of its common stock at a price to the public of $3.30 per share.GLG Life Tech Corporation (TSX:GLG)(NASDA:GLGL), the vertically integrated leader in the agricultural and industrial development of high quality stevia extracts, announced today that it has commenced trading on the NASDAQ Global Market under the symbol "GLGL".PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, announced that it has appointed Geoffrey G. Meyers to the Company’s Board of Directors.Cyberonics, Inc. (Nasdaq: CYBX) today announced that Dan Moore, President and Chief Executive Officer, and Greg Browne, Chief Financial Officer, will present at the 21st Annual Piper Jaffray Health Care Conference in New York on Wednesday, December 2, 2009 at 12:00 PM EST.Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFY® (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.Lannett Company, Inc. (NYSE AMEX: LCI) today announced that its Board of Directors has approved a reauthorization of the stock repurchase program. Under the program the company is authorized to repurchase up to $5 million of Lannett’s outstanding common stock from time to time in open market and privately negotiated transactions.Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced that it will webcast its presentations at the Piper Jaffray 21st Annual Health Care Conference on Wednesday, December 2, 2009 at 2:00 p.m. EST and at the 2009 Deutsche Bank Biotech Boston Confab on Tuesday, December 15, 2009 at 9:00 a.m. EST.OPTIMIZERx Corporation (OTCBB:OPRX) has engaged Beringea LLC, an investment banking and private equity firm, to assist in financial planning and strategic positioning for the company's continued growth.Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) is a complete response.Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that data from a preclinical study on its selective androgen receptor modulator (SARM) LGD-4033 was featured in a poster presentation at the 62nd Annual Meeting of the Gerontology Society of America in Atlanta. LGD-4033 exhibited desirable in vivo efficacy on skeletal muscle and bone measurements in animal models of male hypogonadism and postmenopausal osteoporosis.BD (Becton, Dickinson and Company) (NYSE:BDX) today announced the completion of its acquisition of HandyLab, Inc., an Ann Arbor, Michigan-based company that develops and manufactures molecular diagnostic assays and automation platforms.Soligenix, Inc. (OTC Bulletin Board: SNGX), formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has formed a consortium to develop thermostable technology to advance RiVax(TM) and other rapidly acting vaccines.
Recently, AstraZeneca plc (AZN) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its blood clot preventer Brilinta (ticagrelor). Brilinta is an oral reversible P2Y12 adenosine diphosphate receptor antagonist for arterial thrombosis aimed to compete with the blockbuster drug Plavix which is co-developed by Bristol-Myers Squibb [...]
This morning, Pozen (POZN) initiated phase III studies on PA-325/40, a fixed-dose combination of 325mg enteric coated aspirin and 40mg of immediate release omeprazole. The phase III program will consist of two pivotal trials conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. FDA, and one long-term safety study.
The two pivotal programs [...]
Earlier this week, Bristol Meyers Squibb emerged to the upside from a two-year base-like accumulation pattern when the price structure hurdled and sustained above 23.80-24.00. Since then (Mon morning), BMY has consolidated above its breakout plateau, which I consider to be a very constructive technical sign—that higher prices should be forthcoming. And based on the magnitude of the base pattern, the potential upside target zones are 25.20/50, then 28.00, and possibly 32-33 thereafter. At this juncture, only a failure to remain above 23.80 will compromise the timing of the anticipated upleg.
This morning, Pozen (POZN) initiated phase III studies on PA-325/40, a fixed-dose combination of 325mg enteric coated aspirin and 40mg of immediate release omeprazole. The phase III program will consist of two pivotal trials conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. FDA, and one long-term safety study.
The two pivotal programs will enroll approximately 500 patients per study at over 100 sites around the U.S. The primary endpoint of the pivotal studies is the cumulative incidence of gastric ulcers over the six-month treatment period for PA32540 versus 325 mg of enteric-coated aspirin. The long-term study will enroll approximately 400 patients and assess safety over a period of one year.
Pozen is developing PA-325/40 for use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers. Aspirin is the No. 1 recommended agent for at-risk patients, with some 50 million Americans take daily aspirin therapy for secondary prevention of heart attacks and strokes.
However, according to data presented at the American College of Gastroenterology and at the American Heart Association meeting, the use of low-dose aspirin for cardiovascular disease prophylaxis is associated with a 2- to 4-fold increase in gastro-intestinal (GI) complications, including gastric ulcers. Enteric coating is not a sufficient to reduce the risk of GI bleeding, and thus the majority of patients that should be taking 325mg aspirin are non-compliant or taking suboptimal low-dose (81mg) "baby" aspirin instead.
Pozen’s PA-325/40 is designed to provide immediate-release omeprazole as a GI-protectant for patients taking full-dose 325mg daily aspirin therapy. If the phase III trials meet the primary endpoint of reduction in cumulative incidence of gastric ulcers, we expect PA-325/40 to be approved by the U.S. FDA with the full cardiovascular label claims of regular enteric-coated aspirin. This is a significant market opportunity in our view, considering less than 15% of the 50 million Americans on daily aspirin therapy are taking a GI-protectant such as omeprazole.
Recently, data from a retrospective analysis of patients that use Sanofi-Aventis (SNY) / Bristol-Myers’ (BMY) Plavix (clopidogrel) showed an increased risk of major adverse cardiovascular events (MACE) by as much as 50% while taking a proton pump inhibitor (PPI) such as AstraZeneca’s (AZN) omeprazole (Prilosec) or esomeprazole (Nexium). The data included analysis of outcomes from 16,700 patients who underwent percutaneous coronary intervention and continued Plavix for 12 months after the procedure.
Approximately 9,900 were not given a PPI at any time during Plavix treatment and 6,800 were given overlapping PPI therapy. The analysis showed a 12-month MACE event rate of about 25% among PPI users, compared with 18% of patients who were not given PPI (MACE hazard ratio of 1.50 for PPI users versus nonusers).
The current Plavix label discourages use of a PPI due to this potential limiting effect on the drug’s effectiveness. The majority of Plavix use for secondary prevention of heart attacks and strokes is with enteric-coated aspirin.
Strengthening this label warning by the U.S. FDA could work to greatly limit the potential uptake for Pozen’s PA-325/40 product. However, we note the retrospective analysis that potentially showed a reduced effectiveness for Plavix while on a PPI was with commercially available delayed release PPIs dosed at the same time as taking Plavix. Pozen is currently conducting a drug-drug interaction study with their immediate release omeprazole doses both at the same time and 12 hours apart from Plavix.
The omeprazole used in PA-325/40 is an immediate release formulation, not the commercially available delayed-release found in Prilosec or Nexium. We suspect that dosing an immediate release omeprazole 12 hours apart (say at night) from Plavix (in the morning) will dramatically reduce the potential negative interactions between the two drugs.
We are optimistic on the development plans for PA-325/40. Besides the potential use as a secondary preventative agent for cardiovascular disease, significant literature exists showing a potential reduction in risk for developing precancerous adenomas on high-dose aspirin regimen.
Four separate government-funded randomized controlled trials concluded that aspirin is a benefit in the prevention of adenomas and significantly reduces the risk of colon cancer. However, the dangerous GI tolerability has greatly limited large outcome-based clinical studies or wide-spread use of high-dose aspirin in colon cancer prevention. We believe that Pozen’s PA-325/40, and phase II PA-650/40, have the potential to be a game-changer with respect to colon cancer prevention. This also helps mitigate the potential downside risk to pushing forward with development despite the recent negative Plavix/PPI headlines. Read the full analyst report on "POZN" Read the full analyst report on "SNY" Read the full analyst report on "BMY" Read the full analyst report on "AZN" Zacks Investment Research
Companies featured in this segment: ArcelorMittal (NYSE:MT), OAO Mechel (NYSE:MTL), GlaxoSmithKline plc (NYSE:GSK), Wyeth (NYSE:WYE), Bristol-Myers Squibb Company (NYSE:BMY), General Electric Company (NYSE:GE), Siemens AG (NYSE:SI), Alstom SA (EPA:ALO), Areva SA (EPA:CEI), Severstal OAO (MCX:CHMF), Toshiba Corporation (TYO:6502), Bharat Heavy Electricals Limited (BSE:500103), Tullow Oil plc (OTC:TUWLY), Korean Electric Power Corporation (SEO:015760), Sumitomo Corporation (TYO:8053), Tokyo Electric Power Company Incorporated (TYO:9501), Alinma Bank (SAU:1150), Bank of China Limited (SHA:601988), Banque Saudi Fransi (SAU:1050), Samba Financial Group (SAU:1090), Standard Chartered plc (LSE:STAN)
Companies featured in this segment: Bristol-Myers Squibb Company’s (NYSE:BMY), Laboratory Corporation of America (NYSE:LH), BP plc (NYSE:BP), The Blackstone Group LP (NYSE:BX), General Electric Company (NYSE:GE), StatoilHydro ASA (NYSE:STO), SNC-Lavalin Group Incorporated (TSX:SNC), and Alstom SA (EPA:ALO)
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