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Tuesday 19 December 2006

FDA Issues Safety Warning On Biogen Drug; Stock Is Falling

By: RTT News

Monday, the U.S. Food and Drug Administration or FDA issued a warning to healthcare professionals and patients treated with Rituxan or rituximab about the risk of a serious side effect in patients who were administered the drug. The agency said that it learned of the death of two patients who were treated with Rituxan for systemic lupus erythematosus or SLE, developed progressive multifocal leukoencephalopathy or PML, a fatal viral infection of the central nervous system.

Rituxan, discovered by Biogen Idec Inc., received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL. It was also approved in the European Union under the trade name MabThera in June 1998. In addition, Rituxan received FDA approval in September 2006 for first-line treatment of previously untreated patients with follicular NHL in combination with CVP or cyclophosphamide, vincristine and prednisolone chemotherapy and also for the treatment of low-grade NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy.

Genentech and Biogen issued a letter to inform physicians and other prescribers that two patients died while being treated with Rituxan. The companies also filed the information with the Securities and Exchange Commission or SEC.

Genentech and Biogen co-market Rituxan in the United States, and Roche markets MabThera in the rest of the world. In Japan, Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.

Biogen shares closed lower by $1.13 at $50.23 Monday, and have fallen further in pre-market trading Tuesday. The stock is down an additional $1.97 on 27K shares this morning.

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