Wednesday, March 18, 2009

Chugai Discloses Side Effects of Roche RA Drug: 15 Deaths Reported

TOKYO -- Roche Holding AG's new rheumatoid arthritis treatment might have been a causal factor in the death of 15 out of nearly 5,000 people who took the drug in Japan, with serious side effects such as pneumonia and severe fever detected in over 200 people, Roche's Japanese partner said Wednesday.

The drug, Actemra, is one of Roche's most important new products in development.

A spokesman for Chugai Pharmaceutical Co., which is 60%-owned by Roche, confirmed Japanese media reports on a study into nearly 5,000 users of Actemra. The spokesman said the company "can't deny" that there may have been "a causal relationship" between the drug and the deaths. He said the company will provide more information so that doctors can have a better understanding of possible side effects.

The study was conducted by the Japanese company as part of requirements imposed by Japan's Ministry of Health, Labor and Welfare when the drug was approved.

Roche said that the death rates among patients taking Actemra were similar to those of rheumatoid-arthritis patient populations generally, and also similar to those of patients taking other biological drugs for rheumatoid arthritis. "We don't see a deviation here that gives us reason for concern," a Roche spokeswoman said.

A pharmaceutical analyst for Morgan Stanley said the death rate of roughly 0.3% of Actemra users is similar to the death rate of Enbrel, an "established RA therapy." Morgan Stanley said it continues to forecast peak Actemra sales of 1.65 billion Swiss francs ($1.39 billion) despite the Japanese reports.

Actemra is approved for rheumatoid arthritis in Japan and the European Union but not yet in the U.S., where the Food and Drug Administration has asked the company for a new animal trial of the drug and other information. The biological drug treats rheumatoid arthritis in a new way -- by blocking a protein in the body called IL-6, which plays a role in inflammation.

The Chugai spokesman said his company expects sales of 15.5 billion yen ($157.3 million) for 2009 from the drug, which was first approved in April 2005 in Japan as an agent to treat enlarged lymph nodes and then in April last year to treat rheumatoid arthritis.

Japan's health ministry had requested a study of all Japanese patients who had taken Actemra and Chugai will continue the study until the ministry obtains enough data.

According to the interim results of the study into 4,915 cases, conducted through doctors who prescribed the drug, heavy side effects such as severe fever, pneumonia and phlegmon were found in 221 cases, the Chugai spokesman said.

—Jeanne Whalen contributed to this article
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