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Roche (RHHBY) Receives Approvable Letter for MIRCERA(R) in the United States; Drug Approval Delayed


5/21/2007 10:59:39 AM

NUTLEY, N.J., May 18 /PRNewswire/ -- Roche announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for MIRCERA® for the treatment of anemia associated with chronic renal failure including patients on dialysis and patients not on dialysis.

Roche has received a draft label from the FDA and expects the label to be finalized after the Cardiovascular and Renal Drugs Advisory Committee (CRDAC)* has issued its recommendations on the entire class of erythropoiesis- stimulating agents (ESAs). As announced earlier, the FDA will convene the meeting to consider class topics related to ESAs in the renal setting. Roche and all other sponsors of ESAs in the United States have been informed of the upcoming CRDAC in the fall, and it is understood that recommendations from this meeting could impact the entire class labeling for all ESAs.

"We are confident that MIRCERA will be approved in the United States," said George B. Abercrombie, President and Chief Executive Officer, Hoffmann-La Roche Inc., "and we understand and support the FDA's initiative to convene an advisory panel to review the use of anemia agents in the renal setting. Ultimately, this class review provides the opportunity for Roche to launch MIRCERA into an environment where physicians and patients will have greater clarity on how to use these treatments. Roche will continue to work with the FDA following this meeting in order to expedite the conclusion of the review process."

Roche believes it is important for there to be competition and choice for U.S. patients, providers and physicians in the management of renal anemia.

About MIRCERA

The filing for MIRCERA is based on the largest initial registration program conducted in the renal anemia arena. The program consisted of 10 global studies involving more than 2,700 patients from 29 countries. The Phase III program for MIRCERA consisted of two correction 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). MIRCERA is the only anemia treatment originally designed to correct anemia in chronic kidney disease (CKD) patients with dosing once every two weeks and maintain CKD patients with dosing intervals up to once monthly. It is also the only anemia therapy to have compared itself in clinical trials against all commercially available agents: epoetin alfa, epoetin beta and darbepoetin alfa.

Safety Information

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. There have been rare reports of serious allergic reaction, including skin rash, in patients treated with MIRCERA. Serious gastrointestinal hemorrhages were observed in 1.2% of patients treated with MIRCERA and 0.2% for patients receiving other ESAs.

Erythropoietic therapies increase the risk of death and serious cardiovascular and thromboembolic events when administered to a hemoglobin (Hb) 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.

Chronic Renal Failure and Renal Anemia

Chronic renal failure is also referred to as chronic kidney disease (CKD). According to the National Kidney Foundation, 20 million Americans have CKD and another 20 million are at increased risk. CKD is considered a rising global epidemic because it is linked to two of the fastest-growing diseases - diabetes and hypertension. CKD also increases the severity of these illnesses and the risk of hospitalization and death - which is why CKD is often described as a 'disease multiplier.'

Renal anemia is a common and debilitating complication of CKD that is characterized by a low concentration of hemoglobin in the blood.

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 2006, Roche was named one of the Top 20 Employers (Science magazine), 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.

All trademarks used or mentioned in this release are protected by law.

* The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cardiovascular and renal disorders and makes appropriate recommendations to the Commissioner of Food and Drugs.

Source: Roche

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