FDA Approves MIRCERA(R): First Renal Anemia Treatment with Monthly Maintena...(program for MIRCERA consisted of 10globa...),Health

Date:11/14/2007

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
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SOURCE Roche Copyright©2007 PR Newswire. All rights reserved

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