Biotech Values

[DewDiligence]

Bayer Plans 50,000-Patient (!) Study for Rivaroxaban

[Rivaroxaban, from Bayer and JNJ, is one of the candidates vying to supersede warfarin as the SoC oral anticoagulant for chronic use (#msg-18759853). Rivaroxaban is similar to Apixaban from BMY and PFE (#msg-21044973) but is given only once daily instead of BID. Rivaroxaban is also further along in development. The study described in this newswire will be the largest ever undertaken by Bayer, the largest ever undertaken for any anticoagulant, and one of the largest studies ever undertaken by anyone in any indication.]

http://www.reuters.com/article/marketsNews/idUKL0671513120071106

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Tue Nov 6, 2007 5:28am EST

LEVERKUSEN, Germany, Nov 6 (Reuters) - Bayer is planning a late-stage study for its promising blood-clot drug rivaroxaban for hospitalised patients with internal diseases, the German drugs and chemicals group said on Tuesday.

"It is planned for a total of about 50,000 patients to take part in these studies, making it the largest clinical study programme Bayer has ever undertaken," Chief Executive Werner Wenning told reporters. Wenning said rivaroxaban, which the company wants to market under the trade name Xarelto, is the most promising product in its pipeline.

Rivaroxaban's current indications are prevention of venous thromboembolism, treatment of deep-vein thrombosis, stroke prevention in atrial fibrillation and acute coronary syndrome.

Bayer has already submitted the first registration applications in Europe to market rivaroxaban for prevention of venous thromboembolism following major orthopedic surgery.

"Market introduction in Europe and submission of the registration application in the United States are planned for 2008," Wenning said.

Rivaroxaban is being jointly developed by Bayer and a unit of Johnson & Johnson (JNJ).

Bayer expected annual peak sales potential of rivaroxaban to exceed 2 billion euros.
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