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12:00 AM
 | 
Oct 27, 2008
 |  BioCentury  |  Product Development

The Xa Factor

Anticoagulants are essential therapy for a long list of serious cardiovascular disorders, but the marketed agents heparin and warfarin have well-known problems, including difficult dosing regimens and risk of major bleeding events, leaving the playing field open for new products that can improve safety, especially for chronic indications.

Oral Factor Xa inhibitors are aiming to fill this space, offering less complicated and safer dosing characteristics without the inconvenience of frequent office visits.

The first of these, Xarelto rivaroxaban from Bayer AG and Johnson & Johnson, was approved earlier this month in the EU to prevent venous blood clots in adult patients undergoing elective hip or knee replacement surgery. Xarelto was approved in September in Canada to prevent venous thromboembolic events (VTE) in patients who have undergone elective total hip or total knee replacement surgery. And the partners submitted an NDA to FDA in July to prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee surgery.

Next in line are apixaban from partners Bristol-Myers Squibb Co. and Pfizer Inc., and DU-176b from Daiichi Sankyo Co. BMS recently presented Phase III data on apixaban to prevent VTE and Phase II data in acute coronary syndrome (ACS), while Daiichi presented Phase II data on DU-176b in VTE (see "Factor Xa Pipeline).

Though all three have first targeted acute-use indications, they have their sights set on chronic use for atrial fibrillation (AF) as a replacement for warfarin (see "How They Stack Up," A8).

VTE encompasses DVT and PE.

"Orthopedic VTE prevention is generally the first clinical experience for new anticoagulant mechanisms, in order to get a sense for efficacy and bleeding over a range of doses," BMS VP of R&D Jack Lawrence told BioCentury. "With the clinical data now published on the Factor Xa and direct thrombin inhibitors, some companies will likely opt to go right after the more chronic - that is, more commercially attractive - indications and skip VTE prevention."

The American Academy of Orthopaedic Surgeons puts the number of hip and knee replacements performed in the U.S. at more than 400,000 annually. By comparison, according to the American Heart Association, 2.2 million Americans have AF.

Sales of generic warfarin were $160 million in 2007. Lovenox enoxaparin, a low molecular weight heparin marketed by sanofi-aventis Group, had...

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