Healthcare Industry News:  influenza 

Biopharmaceuticals Litigation

 News Release - October 20, 2006

U.S. Court Begins Discovery Phase in Patent Infringement Suit

Court's Order Doesn't Impact Regulatory Review of Roche's C.E.R.A.

NUTLEY, N.J., Oct. 20 (HSMN NewsFeed) -- The U.S. District Court in Boston scheduled the discovery phase of Amgen's patent infringement suit relating to Roche's C.E.R.A. anti-anemia drug. The Court has not made any determination as to Amgen's claim that C.E.R.A. infringes its patents, and Roche remains confident that it does not infringe any of Amgen's EPO patents.

This Court order does not impact Roche's efforts to seek regulatory approval from the U.S. FDA or other health authorities for its innovative, investigational continuous erythropoietin receptor activator (C.E.R.A.) for the treatment of renal anemia including chronic kidney disease patients on dialysis and not on dialysis. Applications were filed with regulatory authorities in the U.S. and Europe in April this year for a therapeutic area which has historically had few options for physicians or patients.

C.E.R.A. is being developed by Roche to introduce an effective, predictable and convenient twice monthly correction or once monthly maintenance treatment for renal anemia in chronic kidney disease patients.

Safety Information

The most frequent adverse events reported were diarrhea, nasopharyngitis, hypertension, procedural hypotension or influenza. Erythropoietic therapies may increase the risk of cardiovascular and other thrombotic events. Pure Red Cell Aplasia (PRCA) has been observed in patients treated with erythropoietin therapy. To date, PRCA has not been observed with C.E.R.A.

About C.E.R.A.

Roche's innovative investigational anti-anemia agent is the first continuous erythropoietin receptor activator (C.E.R.A.). Its activity at the receptor sites involved in stimulating red blood cell production is different from that observed with traditional epoetin drugs.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or www.roche.us


Source: Roche

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