Biotech Values

[DewDiligence]

BMY, PFE to Submit Apixaban MAA in 1H10

[Some sell-side analysts recently speculated that data from the third phase-3 Apixaban trial in VTE prevention (called ADVANCE-3) must be bad—else the companies would have found a way to present at least the top-line data at ASH. The analysts could be right, of course; however, the fact that BMY and PFE will submit an MAA for EU approval in 2010 presumably means that the ADVANCE-3 data are not *awful*.

Refresher: BMY and PFE ran three similar head-to-head trials of Apxiban vs Lovenox in VTE prevention called ADVANCE-1, -2, and -3. ADVANCE-1, in patients undergoing knee surgery, failed (#msg-31742223), but ADVANCE-2, also in knee surgery, succeeded (http://www.hemonctoday.com/article.aspx?rid=41557 ). ADVANCE-3, in patients undergoing hip surgery, finished a few months ago, but no data have been reported (http://clinicaltrials.gov/ct2/show/NCT00423319 ). Because ADVANCE-1 failed, a regulatory submission to the FDA and EU for Apixaban in VTE prevention will be based on ADVANCE-2 and ADVANCE-3.]

http://finance.yahoo.com/news/ADDING-MULTIMEDIA-bw-1792239649.html/print?x=0

›Bristol-Myers Squibb And Pfizer Announce Plans To Submit Regulatory Filing For Apixaban In Europe

7:35 pm EST, Friday December 4, 2009

PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer (NYSE: PFE) today announced that the companies are planning to submit an application for regulatory approval of apixaban in Europe for the prevention of venous thromboembolism (VTE) after orthopedic surgery in the first half of 2010. The application will be supported by ADVANCE-2 and ADVANCE-3 [but not ADVANCE-1], two clinical trials that evaluated apixaban versus the European dosing regimen of enoxaparin for prevention of VTE in patients undergoing orthopedic surgery. Results of ADVANCE-2 were first presented in July 2009 at the 22nd Congress of the International Society on Thrombosis and Haemostasis in Boston. The ADVANCE-3 data will be submitted for publication and presentation in 2010. [Why not at ASH?]

Apixaban is a novel, oral, highly selective Factor Xa inhibitor, a new class of agents being studied for the potential to prevent and treat blood clots in the veins and arteries.

About the Bristol-Myers Squibb/Pfizer Collaboration

In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize apixaban, an investigational oral anticoagulant discovered by Bristol-Myers Squibb being studied for the prevention and treatment of a broad range of venous and arterial thrombotic conditions. This global alliance combines Bristol-Myers Squibb's long-standing strengths in cardiovascular drug development and commercialization with Pfizer’s global scale and expertise in this field to maximize the potential benefits of apixaban for patients.‹