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Friday, 09/30/2011 1:29:14 PM

Friday, September 30, 2011 1:29:14 PM

Post# of 252388
JNJ/Bayer/Xarelto

http://www.bloomberg.com/news/print/2011-09-30/bayer-j-j-s-xarelto-helped-acute-coronary-syndrome-patients.html

>>Bayer, J&J’s Xarelto Helped Acute Coronary Syndrome Patients
By Naomi Kresge - Sep 30, 2011

Bayer AG (BAYN) and Johnson & Johnson (JNJ)’s blood thinner Xarelto helped patients who recently suffered a heart attack or severe chest pain, succeeding in an area in which a competitor from Pfizer Inc. (PFE) and Bristol-Myers Squibb Co. (BMY) failed last year.

Xarelto reduced the rate of heart attacks, strokes and cardiovascular death versus placebo, Leverkusen, Germany-based Bayer said in a statement late yesterday. The study, known as Atlas, combined either Xarelto or a placebo pill with standard blood-thinning therapy. Patients who took Xarelto faced a higher risk of major bleeding, a feared side effect of blood thinners, Bayer said.

The results are a “surprise win” for Bayer and J&J, and may “modestly” help them compete with Bristol-Myers and Pfizer’s Eliquis, AstraZeneca Plc (AZN)’s Brilinta and Eli Lilly & Co. (LLY)’s Effient, Seamus Fernandez, a New York-based analyst for Leerink Swann & Co., wrote in a note to investors today.

Bayer and J&J are awaiting a ruling from US regulators on whether Xarelto, known chemically as rivaroxaban, may be sold for a bigger group of patients with an irregular heartbeat known as atrial fibrillation. A Food and Drug Administration advisory panel voted 9-2 in support of the drug this month. The findings announced yesterday may broaden Xarelto’s availability in hospitals, which would make the drug a stronger competitor for atrial fibrillation patients as well, Ferdandez said.

Extrapolations to Xarelto’s benefit for atrial fibrillation patients may be difficult, however, because Bayer used a different dose of the drug for those patients, Mark Schoenebaum, a New York-based analyst for ISI Group, wrote in a note to clients today.

Pfizer and Bristol-Myers halted a trial of Eliquis, also known as apixaban, in November after an increase in bleeding outweighed benefits for patients with acute coronary syndrome.

Bayer said it will ask regulators to approve Xarelto for acute coronary syndrome patients by the end of the year. The company said it will present full results of the Atlas trial at a medical conference.<<

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