Roche maintains its position that its novel, investigational anti-anemia medicine C.E.R.A. does not infringe any of Amgen's U.S. patents for epoetin. The company will continue to focus its efforts on obtaining regulatory approval from U.S. and EU health authorities for C.E.R.A., which is in development for the treatment of renal anemia in chronic kidney disease patients on dialysis and not on dialysis. The U.S. has the largest population worldwide of patients suffering from chronic kidney disease with estimates of 20 million Americans or more.
William M. Burns, CEO Roche Pharma Division, said: "The ITC's decision supports our long-term efforts to develop C.E.R.A. We want to offer doctors and patients in the United States the choice of a novel medicine that has been created to allow longer dosing intervals of up to every four weeks - something that currently does not exist in the United States. Our energies are focused on continuing our dialogue with health authorities regarding our filings which occurred in April this year and on further clinical trials to manage this oxygen-depriving condition."
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.
Safety Information
The most frequent adverse events, which were similar between the treatment arms, were diarrhea, nasopharyngitis, hypertension, procedural hypotension or influenza. Erythropoetic 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. in clinical trials.
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
