Hello, everyone. A rainy day here on the Pharmalot corporate campus, but we try to keep our spirits sunny. No reason not to do so, after all. As the Morning Mayor used to say, 'Every brand new day should be opened like a precious gift.' So let us unwrap the bow. And then grab a cup of stimulation. Hope your day goes well, and stay in touch...
Medivation Lays Off 20 Percent Of Staff (Bloomberg News)
Astra, Abbott Heart Drug Delayed (Reuters)
Judge Tosses Plavix Antitrust Suit (Dow Jones)
Astellas And OSI Sign Confidentiality Agreement (Bloomberg News)
Genvec Ends Cancer Drug Trial (Reuters)
1 Comment
On the Medivation drug failure story, I place the blame squarely with Pfizer on this one. For a drug to fail this way in Phase III means that Pfizer didn't do proper due diligence when acquiring the drug candidate.
It may seem surprising to some but 10-20 years ago, drugs almost never failed in Phase III trials compared to today's high failure rate. It's not because us clinical researchers have become dumber. The reasons are economically driven. In the "old days", most Pharma companies would spend 3-4 years in Phase II clinical development, doing many studies, which, when successful assured a higher probability of success in the more expensive Phase III studies. This was good science and good business. Accordingly, Merck had the best track record, i.e, 95% of its candidates entering Phase III ultimatele gained FDA approval.
In today's economic environment, companies are pushing out Phase II data in 12-18 months, or are relying on altogether unproven strategies, such as biomarkers or proof of concept studies in order to propel them directly into Phase III. While this may appease shareholders on a short-term basis, it ultimately means higher failure rates in Phase III.
http://www.pfizer.com/news/press_releases/pfizer_press_releases.jsp?rssUrl=http://mediaroom.pfizer.com/portal/site/pfizer/index.jsp?ndmViewId=news_view&ndmConfigId=1020733&newsId=20100303005865&newsLang=en