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Biotech / Medical : Biotech success, 2002

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To: Miljenko Zuanic who wrote (71)5/21/2002 12:01:04 AM
From: Miljenko Zuanic  Read Replies (1) of 117
 
93% viral response!

Monday May 20, 8:43 am Eastern Time
Reuters Company News
Roche says Pegasys drug effective in liver patients

ZURICH, May 20 (Reuters) - Roche Holding AG's (ROCZg.VX) Pegasys drug for treating hepatitis C seems to be effective for patients with advanced liver disease, according to preliminary results of a study reported on Monday by the company.

Early results of the trial by the Swiss Association for the Study of the Liver show that Pegasys in combination with a standard dose of ribavirin reduced hepatitis C virus below detection levels in 93 percent of patients with advanced fibrosis or compensated cirrhosis after 24 weeks of therapy.

"These positive interim results continue to reinforce that Pegasys combined with ribavirin is highly effective and acceptably tolerated among patients with difficult to treat disease who are in high need of therapy," said the study's principal investigator, Eberhard Renner, head of hepatology at University Hospital in Zurich.

The interim analysis presented at a U.S. conference covered the first 61 patients who have completed 24 weeks of therapy.

Pegasys, or peginterferon alfa-2a, is a once-a-week injection drug that is set to be Roche's main new product launch this year.

A European Union advisory panel recommended in March that the drug get marketing approval. Roche expects U.S. approval as well late this year after a delay caused by regulators' insistence that it show a change in the manufacturing process had not altered the drug's properties.

That gave rival Schering-Plough Corp's (NYSE:SGP - News) PEG-Rebetron product a head start in the big U.S. market.

Pegasys has already been approved in 20 countries and analysts think it could have peak sales of $1 billion by 2006.
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