Biotech Values

[DewDiligence]

The Apixaban success in atrial fib/stroke prevention is a big deal
for PFE and an even bigger deal for BMY (because it takes less
to move the needle for BMY). The 2007 article in #msg-25160571
is still a good background read on the huge upside for the new
oral anticoagulants, as are some of the entries in #msg-50887846.

http://online.wsj.com/article/SB10001424052748704312104575299151703664036.html

›Bristol, Pfizer Halt Anti-Clotting Trial on Signal of Benefit

JUNE 10, 2010, 6:09 P.M. ET
By PETER LOFTUS

Bristol-Myers Squibb Co. and Pfizer Inc. said Thursday that they stopped a clinical trial early because the data so far suggest an experimental drug for irregular heart rhythm was superior to aspirin.

The drug, apixaban, is designed to prevent clotting of the blood. The New York-based drugmakers studied apixaban in people with atrial fibrillation, a disease involving irregular heartbeat that increases the risk for stroke.

Wall Street expects apixaban and similar anti-clotting drugs under development at other companies to be big sellers. Barclays recently estimated the market for these drugs could reach $12 billion by 2021, and apixaban alone could generate peak annual sales of about $3.6 billion. Johnson & Johnson and Bayer AG are among other companies that have developed drugs in this class. [See #msg-50887846 for a compilation of the anticoagulants from various companies.]

The study compared apixaban with aspirin in people who are unable to take a commonly used anti-clotting drug, warfarin. The companies said an independent committee monitoring the study "revealed clear evidence of a clinically important reduction in stroke and systemic embolism" in apixaban users, versus those on aspirin. The companies said the interim analysis also demonstrated an "acceptable" safety profile for apixaban versus aspirin.

The companies didn't release the specific efficacy or safety results of the study. They plan to publish the full data in a medical journal and present the findings at a scientific meeting once the data are fully evaluated, said Bristol spokeswoman Laura Hortas.

The study included about 5,600 patients in 36 countries. It began in September 2007 and had been projected to run until about August 2010.

The companies are conducting a larger trial comparing apixaban with warfarin in atrial-fibrillation patients. It's also being studied to prevent certain types of blood clots in people who undergo various kinds of surgery. The companies already have filed for European regulatory approval of the drug to prevent clots known as venous thromboembolism. [The US regulatory status of Apixaban for VTE prevention remains unclear due to the mixed phase-3 outcomes (#msg-47461590, #msg-31742223).].‹