Healthcare Industry News: erythropoiesis-stimulating agent
News Release - October 23, 2007
Roche Considering Legal Options In Patent Litigation CaseNUTLEY, N.J.--(HSMN NewsFeed)--Roche announced today that a jury in the U.S. District Court in Massachusetts found in favor of Amgen in the patent infringement dispute relating to the Roche erythropoiesis-stimulating agent, MIRCERA® . Roche is currently evaluating its legal options, including the possibility of an appeal.
Roche maintains its position that all of Amgen’s patents for epoetin asserted against Roche are invalid and not infringed, and believes the facts and the law support that position.
“The jury’s verdict is disappointing because it is a loss for U.S. patients with chronic kidney disease who are being deprived of the opportunity to benefit from options in the management and treatment of renal anemia. We believe it is important for there to be competition and choice in this country. Amgen has had an extended monopoly for the last 20 years not allowing for new therapeutic options to treat anemia to be introduced to patients in this country,” said George Abercrombie, president and CEO of Hoffmann-La Roche Inc.
MIRCERA is currently awaiting FDA approval which is expected on November 14th. MIRCERA was already approved in July in the European Union, and in Switzerland and Norway in September. MIRCERA has been recently launched in Austria, Sweden, Germany and the UK. Studies with MIRCERA have shown that the treatment corrected and maintained hemoglobin levels with fewer injections than currently available erythropoiesis-stimulating agents (ESAs).
The clinical program for MIRCERA consisted of 10 global studies involving more than 2,700 patients from 29 countries. The Phase III program for MIRCERA included two correction studies and four maintenance studies exploring intravenous (IV) and subcutaneous (SC) MIRCERA at extended administration intervals.
MIRCERA has a longer half-life than any commercially available erythropoiesis-stimulating agent (ESA). In clinical trials MIRCERA corrected anemia in chronic kidney disease (CKD) patients with dosing once every two weeks and maintained hemoglobin levels in CKD patients with dosing intervals up to once monthly.
MIRCERA has a demonstrated safety profile comparable to other erythropoietic agents.
The most commonly reported adverse events in the MIRCERA Phase II/III clinical program were hypertension, nasopharyngitis, diarrhea, headache, and upper respiratory tract infection.
Erythropoietic therapies increase the risk of death and serious cardiovascular and thromboembolic events when administered to a hemoglobin of greater than 12 g/dL. A rate of Hb rise of >1 g/dL over 2 weeks may also contribute to these risks.
Erythropoiesis stimulating agents, when administered to target a hemoglobin of greater than 12 g/dL, have shortened the time to tumor progression, shortened survival and increased the risk of death in cancer patients.
Pure Red Cell Aplasia (PRCA) has been observed in patients treated with erythropoietin therapy. However, PRCA has not been observed with MIRCERA in clinical trials to date.
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 in the U.S., Roche 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 2007 Roche was named Top Company of the Year by Med Ad News and one of the Top 20 Employers (Science magazine). In 2006, Roche was ranked the No. 1 Company to Sell For (Selling Power), and one of AARP’s Top Companies for Older Workers, and in 2005, Roche was named one of Fortune magazine’s Best Companies to Work For in America. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or www.roche.us.
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Source: Roche Group
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