A Step Forward for Bayer

The therapeutic area of Atrial Fibrillation (AF) is buzzing with news. We are pleased with the development made by Bayer Schering Pharma, a division of Bayer Healthcare in this field. The company completed patient enrollment in the phase III study for Rivaroxaban (Xarelto). The study aims to assess the efficacy and safety of this drug against Bristol-Myers Squibb’s (BMY - Analyst Report) warfarin, which is primarily used for the prevention of stroke in AF patients.

The study is expected to include about 14,269 patients spanning over 45 countries with results due by next year. Atrial fibrillation is the most common heart rhythm abnormality in the US. An estimated 3 million people in the US have atrial fibrillation, which affects about one in 10 people aged over 70.

Rivaroxaban, jointly developed with Johnson and Johnson (JNJ - Analyst Report) is also being studied for the treatment of venous thromboembolism (VTE) and deep vein thrombosis (DVT) (apart from AF). The drug is approved in the European Union (EU) for the prevention of venous blood clots in adult patients who have undergone elective (planned) hip or knee replacement surgery.

Xarelto was submitted in July 2008 for approval to the US Food and Drug Administration (FDA), and the agency’s advisory committee voted 15-2 recommending its approval in the US in March 2009. A final decision is expected later this year. Xarelto offers multi-billion dollar sales potential. Upon approval, J&J will market the drug in the US while Bayer holds ex-US marketing rights.
 
In July 2009, the US FDA approved Sanofi-Aventis’ (SNY - Analyst Report) Multaq, the first new drug for AF to be approved in a decade.  Viewing the high unmet need of the AF market, many companies have pipeline candidates this area. Merck is developing vernakalant intravenous for AF patients, for which it is seeking European Medicines Agency (EMEA) approval.

Moreover, Bristol-Myers and Pfizer (PFE - Analyst Report) are co-developing apixaban in addition to Boehringer Ingleheim GmbH’s Pradaxa (dabigatran). Though warfarin is widely used to prevent blood clot, it has certain limitations like careful regulation of blood levels to prevent overdose and reaction with some green vegetables. Any of these drugs on approval has the potential to reach blockbuster status.

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