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Biotech / Medical : INHL - Inhale Therapeutics - Pulmonary Insulin! -- Ignore unavailable to you. Want to Upgrade?

To: michael_f_murphy who wrote (203)	10/17/2002 12:44:24 AM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 225

Reuters Company News Roche wins FDA approval for hepatitis C drug Wednesday October 16, 9:09 pm ET (adds details, paragraph 9) NUTLEY, N.J., Oct 16 (Reuters) - Roche Holding AG (ROCZg.VX) won approval to sell hepatitis C treatment Pegasys, its biggest new drug this year, in the key U.S. market, the company said on Wednesday. ADVERTISEMENT The U.S. Food and Drug Administration approved Pegasys as a stand-alone therapy for treating adults with chronic hepatitis C, a viral infection that attacks the liver and often kills, Roche said. The Swiss drugs group, which recently reported flat nine-month core sales, is counting on Pegasys to help revive its fortunes. Annual sales for Pegasys, approved in Europe in June, may peak at some 1.5 billion Swiss francs ($1 billion U.S.), Roche has said. Pegasys will compete with Schering-Plough Corp.'s (NYSE:SGP - News) Peg-Intron, which got a head start in the U.S. market last year while Pegasys hit delays. Both drugs are longer-acting versions of the antiviral protein interferon. An estimated 170 million people worldwide have hepatitis C, a blood-borne infection commonly transmitted by injection drug users who share needles. Many infected people have no symptoms, but the disease can lead to cirrhosis, liver damage and death. It is the leading reason for liver transplants in the United States. With Pegasys, "you have a new medication with superior efficacy to the older treatments. Patients tolerate it better, and it's easy to give to themselves," said Dr. David Bernstein, director of hepatology at North Shore University Hospital in Manhasset, New York, and a researcher on the Pegasys trials. Pegasys, a once-a-week injection, was linked to fewer side effects, such depression and flu-like symptoms, that can occur with three-times-a-week interferon injections, Bernstein said. Roche said it will provide doctors with enough free samples of Pegasys to treat up to 15,000 patients for 12 weeks, which is the amount of time it takes for physicians to tell whether a patient will respond to the drug. The therapy's recommended course is 48 weeks, according to Roche spokeswoman Pamela Van Houten. Roche said it expects Pegasys to be available at pharmacies within two weeks.