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Xarelto/ROCKET AF phase III trial results:

Bayer Blood Thinner Xarelto Matches Warfarin in Irregular-Heartbeat Trial

http://www.bloomberg.com/news/2010-10-31/bayer-s-xarelto-matches-warfarin-in-rocket-af-trial-update1-.html

By Naomi Kresge - Nov 1, 2010

Bayer AG’s blood thinner Xarelto matched the standard therapy at preventing blood clots in patients with an irregular heartbeat, results that may determine its success in a market worth as much as $14 billion a year.

Xarelto was as effective as warfarin, the standard treatment over the past half century, Leverkusen, Germany-based Bayer said yesterday in the first comparison between the two drugs. Xarelto had “comparable” safety and rates of bleeding versus the standard, Bayer said.

Boehringer Ingelheim GmbH last month beat Bayer and its partner Johnson & Johnson to market with the first warfarin replacement. Investors now want to know whether, like its competitor from Boehringer, Xarelto is better than, and not simply equal to the older treatment, Jack Scannell, a London- based analyst with Sanford C. Bernstein Ltd., said in a note to investors today. Bayer and J&J will present full results of the trial, called Rocket-AF, at the American Heart Association conference on Nov. 15.

“Bayer might be hiding good news,” Scannell said. He rates the shares “outperform.”

The stock rose as much as 3 percent in Frankfurt trading, the most in two months, and were up 1.43 euros, or 2.7 percent, to 55.05 euros at 9:23 a.m.

Market Estimate

The market for new blood thinners including Xarelto may surpass 10 billion euros ($14 billion) a year, and Xarelto sales may peak at more than 2 billion euros, Bayer Chief Executive Officer Marijn Dekkers estimated in a Bloomberg Television interview on Oct. 28. Pfizer Inc. and Bristol-Myers Squibb Co. are also working on a replacement for warfarin.

Xarelto matched standard treatments for clots in the lungs and legs in a study, Einstein-DVT, released in August. Medicines to prevent clots after knee surgery or in the lungs and legs are a small part of the blood-thinner market compared with drugs for people with an irregular heartbeat, Flemming Oernskov, head of the women’s health and general medicine unit at Bayer, said in an interview at the time.

Patients with an irregular heartbeat, or atrial fibrillation, face a risk of clots as blood pools in the upper chamber of their hearts. Doctors have relied on warfarin and aspirin to ward off the strokes that may result if a clot gets stuck in the artery to the brain.

J&J has said it will request U.S. regulatory approval next year to sell Xarelto for hip and knee surgery patients. The Food and Drug Administration didn’t approve the drug at its first review in May 2009, instead asking for more information.