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 ...
For Eli Lilly (LLY), health care reform is an 800-pound gorilla. The maker of branded pharmaceuticals — as well as the whole industry — is waiting to see what reforms come out of Congress. Until then, Miller Tabak analyst Les Funtleyder says, investors won't be rushing in. But it's not just one oncoming, potentially harmful force, he adds. "You probably won't see investors flocking until reform is over and Lilly proves (its) pipeline," he said.
Vivus (VVUS) is raising the bar on erectile dysfunction drugs potentially becoming the latest formidable competitor to Viagra and Cialis in the $3.8 billion market. Investors in the California-based pharmaceutical company jumped on Wednesday when the company cited positive results from a late-stage study of its erectile dysfunction drug avanafil. The stock shot up almost 6% in early morning trading while shares of Pfizer (PFE) which makes Viagra and Eli Lilly (LLY) maker of Cialis remained relatively flat. Vivus announced the results from its phase 3 Revive study which tested the safety and efficacy of avanafil for the treatment ...
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 [...]
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 (BMY) and Sanofi-Aventis (SNY). On Oct 26, 2009, AstraZeneca filed for approval of the drug with the European Medicines Agency (EMEA) and is awaiting validation of the application.
AstraZeneca is seeking an FDA approval of Brilinta primarily on the basis of data from PLATO (a study of Platelet Inhibition and Patient Outcomes), a late-stage 18,624 patient trial, that showed that Brilinta was more effective than Plavix in treating patients with acute coronary syndrome (ACS) in 43 countries. Brilinta treatment resulted in a reduction of cardiovascular events (CV death, MI or myocardial infarction, stroke) over clopidogrel (Plavix), without an increase in major bleeding. Brilinta is the first investigational antiplatelet that has demonstrated a reduction in CV death versus Plavix in ACS patients.
As a reminder, PLATO evaluated the efficacy, safety and tolerability of Brilinta versus Plavix. The trial design prospectively identified 66 subgroups including 33 efficacy and 33 safety subgroups. The findings from 62 of the 66 subgroups were consistent with the results in the overall study population.
ACS represents conditions that result from a reduction in blood flow to the heart muscle, including unstable angina and myocardial infarction. According to data from the American Heart Association, approximately 1.4 million people in the United States are affected by ACS annually.
We believe that if Brilinta gets FDA approval and enters the approximately $9 billion anticlotting medicine market, it would provide increased competition to Plavix, which is one of the largest selling drugs globally with sales of $5.6 billion in 2008. Plavix already has to contend with a new player in the market, Eli Lilly’s (LLY) Effient. Moreover, Plavix will lose patent protection in 2011 resulting in huge loss of revenues for Bristol. If AstraZeneca can get Brilinta on the market before Plavix goes generic, it may help Brilinta maintain its market share and reduce the number of patients switching to generic clopidogrel.
Increasing exposure to patent expiries and downward trends in pipeline quality continue to underpin Moody’s negative outlook for the industry, though the outlook for generics is more positive.
Excerpts from Moody’s latest Global Pharmaceuticals Firms Industry Outlook:
Companies have taken measures to alleviate these pressures – mainly through acquisitions; M&A strategies are expected to remain a key [...]
We all want to succeed in everything that we do, including investing in the stock market. Though I have no analytical data to back it up, I am convinced that most people will lose money in the stock market over their lifetime. So why do so few people succeed at investing? Could it be that an individual's desire to succeed be a significant reason for their failure.[More...]
Bristol-Myers Squibb Co. (BMY) intends to split its 83.1% holding in the Nutritional segment which operates under its subsidiary Mead Johnson and develops infant formulas such as Enfamil and other nutritional products. The move is aimed to enable the company to concentrate on its core biopharmaceutical business. The transaction is expected to be accretive to [...]
Companies featured in this segment: Genzyme (NASDAQ:GENZ), Eli Lilly & Company (NYSE:LLY), NiSource Incorporated (NYSE:NI), General Electric (NYSE:GE), Siemens AG (NYSE:SI), The Dow Chemical Company (NYSE:DOW), Progress Energy’s (NYSE:PGN), Covanta Holding Corporation (NYSE:CVA), Sumitomo Chemical Company Limited (TYO:4005), Steel Authority of India Limited (BSE:500113), Endesa (MCE:ELE), and Saudi Basic Industries Corporation (SAU:2010)
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