Biotech Values

[DewDiligence]

Bayer Accelerates Xarelto Development

[This is simply a good business decision: when your main competitor stumbles—as PFE and BMY recently did with Apixaban (#msg-31742223), the drug candidate most similar to Xarelto—you take advantage by going for the jugular. For additional info on Xarelto (Rivaroxaban), please see #msg-29662519, #msg-24337258, #msg-30972846, and #msg-31073048.]

http://www.reuters.com/article/marketsNews/idINLV15510920080831

›Sun Aug 31, 2008 8:31am EDT
By Ben Hirschler

MUNICH, Aug 31 (Reuters) - Bayer AG (BAYG.DE) is to accelerate the development programme for Xarelto, an anticoagulant that is its most important pipeline product, the German drugmaker said on Sunday.

The news comes hard of the heels of a setback for a rival product, apixaban, from Bristol-Myers Squibb Co and Pfizer Inc.

Bayer and its partner Johnson & Johnson (JNJ) will now start a final-stage Phase III trial of Xarelto for preventing acute coronary syndrome (ACS) -- an umbrella term covering symptoms ranging from severe chest pain to heart attacks – earlier than the previously planned date of second half of 2009.

Bayer did not give a precise timetable for the Phase III programme but said results from a large Phase II study for preventing ACS in vulnerable patients would be presented on Nov. 10 at the American Heart Association's annual meeting in New Orleans.

"With the early availability of Phase II data, the companies are now planning to accelerate the clinical development programme in this indication," Bayer said.

Bayer estimates eventual global peak sales of Xarelto, which won a positive recommendation from the European Medicines Agency in July for preventing blood clots after orthopaedic surgery, could reach 2 billion euros ($3 billion) a year for all indications.

Both Xarelto and apixaban work by blocking a protein called Factor Xa.

Bristol-Myers Squibb and Pfizer said last week they no longer plan to seek marketing approval next year for apixaban in post-surgery clot prevention, after the drug failed its primary goal in a late-stage trial.

Further clinical trial results with apixaban are awaited, including an update on Tuesday on its use in ACS at the annual meeting of European Society of Cardiology in Munich.

Analysts say apixaban's recent setback, though not a disaster, will consolidate Xarelto's first-mover advantage.

The initial use of Xarelto will be in preventing blood clots after hip- and knee-replacement surgery, but the big commercial opportunities lie in using it in ACS and to prevent strokes in people with atrial fibrillation, a common heart arrhythmia.

It will compete in the initial surgical setting with Sanofi-Aventis SA's (SNY) top-selling injectable drug Lovenox, which is currently the standard treatment given to patients after major orthopaedic operations. Worldwide sales of Lovenox totalled 2.6 billion euros in 2007.

It also faces a newer competitor in the form of Boehringer Ingelheim's blood clot drug Pradaxa, which inhibits thrombin [#msg-27956748]. Pradaxa was approved in Europe in March.‹


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