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FDA Approves MIRCERA(R): First Renal Anemia Treatment with Monthly Maintenance Dosing

NUTLEY, N.J., Nov. 14 /PRNewswire-USNewswire/ -- Roche announced today that the U.S. Food and Drug Administration (FDA) has approved MIRCERA (methoxy polyethylene glycol-epoetin beta) for the treatment of anemia associated with chronic renal failure (CRF) in adults, including patients on dialysis and patients not on dialysis. CRF is commonly known as chronic kidney disease (CKD). MIRCERA is the only FDA-approved erythropoiesis-stimulating agent (ESA) to provide correction of anemia with once-every-two-week dosing. MIRCERA is also the only FDA-approved ESA to maintain stable hemoglobin levels with once-monthly or once-every-two-week dosing in CKD patients. MIRCERA offers the added convenience of storage at room temperature for extended time periods when necessary.

The outcome of an ongoing patent case will determine when patients can gain access to MIRCERA in the United States. Following approval by the European Agency for the Evaluation of Medicinal Products (EMEA), MIRCERA has already been launched in Austria, Sweden, Germany, the United Kingdom and Norway, and will continue its international rollout.

"Roche is pleased that the approved FDA label reflects the differentiating characteristics of MIRCERA," said George B. Abercrombie, President and Chief Executive Officer, Hoffmann-La Roche Inc. "In Europe, thousands of patients with chronic renal failure and their physicians are receiving effective, predictable and convenient anemia treatment with MIRCERA, and we are hopeful that patients and healthcare providers in the U.S. will be able to have access to MIRCERA as soon as possible, in a responsible and legal manner."

In contrast to erythropoietin, MIRCERA is an erythropoietin receptor activator with greater activity in vivo as well as increased half-life. MIRCERA has the longest half-life of all FDA-approved ESAs, up to six times longer than darbepoetin alfa and up to 20 times longer than epoetin.

The initial registration clinical program for MIRCERA consisted of 10 global studies involving more than 2,700 patients from 29 countries. The Phase III data supporting the FDA approval for MIRCERA consisted of two correction and four maintenance studies exploring intravenous (IV) and subcutaneous (SC) MIRCERA at extended administration intervals.

In clinical trials, MIRCERA was as effective as other ESAs in correcting renal anemia in patients with CKD on dialysis and not on dialysis. Up to 97.5 percent of patients who were not currently receiving an ESA achieved target Hb levels (greater than or equal to 11g/dL) with once-every two week dosing of MIRCERA. Patients maintained stable Hb levels (plus or minus 1g/dL) when switched to MIRCERA from a shorter-acting frequently administered ESA treatment regimen. MIRCERA has a safety profile comparable to other erythropoietic agents.

About the Patent Litigation Case

Last month, a jury in the U.S. District Court in Massachusetts found in favor of Amgen in the patent infringement dispute relating to MIRCERA. Roche is currently evaluating its legal options, including the possibility of an appeal. The company 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. Roche believes strongly that it is important for there to be treatment options for patients with CKD and their health care providers and looks forward to presenting its case at a judicial hearing regarding a potential injunction.

Safety Information

In chronic renal failure, patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents to target higher vs. lower hemoglobin levels. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10-12 g/dL. This is consistent with new class labeling for all other ESAs.

MIRCERA is not indicated for the treatment of anemia due to cancer chemotherapy.

MIRCERA is contraindicated in patients with uncontrolled hypertension and in patients with a history of hypersensitivity or allergy to MIRCERA.

Pure Red Cell Aplasia (PRCA) and severe anemia have been associated with the development of neutralizing antibodies to erythropoietin in patients treated with ESAs. PRCA was not observed with MIRCERA in clinical trials. If anti-erythropoietin antibody-associated anemia is suspected, withhold MIRCERA and other ESAs.

The most common adverse reactions are hypertension, diarrhea, nasopharyngitis, headache, and upper respiratory tract infection.

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 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: or

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