Hoffmann-La Roche Inc. Release: C.E.R.A. Corrected Anemia In Chronic Kidney Disease Patients With An Extended Dosing Regimen, Studies Show

SAN DIEGO, and NUTLEY, N.J., Nov. 18 /PRNewswire/ -- New phase III data show Roche's investigational treatment, C.E.R.A., was as effective as existing medications when dosed less frequently for correcting untreated renal anemia in patients with chronic kidney disease (CKD) on dialysis and not on dialysis. These data are part of the largest initial registration program ever conducted for the treatment of renal anemia. In these studies, C.E.R.A., dosed every 2 weeks, achieved as effective a response rate* for correcting renal anemia as currently approved, more frequently-dosed agents. The data were presented today at the 39th Annual Meeting of the American Society of Nephrology in San Diego, CA.

"Effective elevation and predictable control of hemoglobin are key to managing renal anemia," said Robert Provenzano, MD, FACP, Division of Nephrology, St. John Hospital and Medical Center in Detroit, Michigan. "These results show C.E.R.A. may provide doctors with a way to manage anemia with less frequent dosing."

Renal anemia is a common and debilitating complication of CKD that's characterized by a low concentration of hemoglobin (Hb) in the blood. Inadequate Hb levels deprive the body's tissues of oxygen and can lead to serious cardiovascular complications and even death if left untreated. Treatment guidelines recommend specific ranges for doctors to target and maintain as excessive Hb correction is not associated with additional benefit and has been linked to increased risk. Most CKD patients receive anti-anemia treatment as often as 52-156 times a year because existing agents for renal anemia are short-acting, requiring frequent administration to keep Hb levels within guideline ranges. Today's results indicate C.E.R.A. may successfully correct Hb with once every two week dosing.

About the ARCTOS and AMICUS studies

The primary objective for the two phase III correction studies, called ARCTOS (Administration of C.E.R.A. in CKD Patients to Treat Anemia with a Twice MOnthly Schedule) and AMICUS (C.E.R.A. AdMinistered Intraveneously for Anemia Correction and SUStained Maintenance in Dialysis), was to examine the effectiveness of subcutaneous (SC) and intravenous (IV) C.E.R.A. at extended administration intervals in correcting anemia and maintaining Hb levels in treatment-naive patients with CKD either on dialysis or not on dialysis. The studies used epoetin alfa/beta or darbepoetin alfa as comparator agents in a non-inferiority design. Details for the individual studies are as follows:

-- C.E.R.A. (Continuous Erythropoietin Receptor Activator) Administered at Extended Intervals Corrects Anemia and Maintains Stable Hb Levels in Patients with CKD Not on Dialysis (ARCTOS) [SA-PO208] In the ARCTOS trial, 324 patients with CKD who were not on dialysis were randomized to either C.E.R.A. once every two weeks or darbepoetin alfa once a week subcutaneously. The response rate was 97.5 percent for C.E.R.A. and 96.3 percent for darbepoetin, indicating C.E.R.A. was effective in correcting Hb levels with a once every two week dosing regimen. After 28 weeks, patients who responded to C.E.R.A. were randomized to continue treatment either once every two weeks or once every four weeks; patients on darbepoetin remained on once-weekly treatment. -- C.E.R.A. (Continuous Erythropoietin Receptor Activator) Administered at Extended Intervals Corrects Hb Levels in Patients with CKD on Dialysis (AMICUS) [SA-PO212] The AMICUS study compared intravenous C.E.R.A. once every two weeks to epoetin alfa or epoetin beta 1-3x/wk, in 181 dialysis patients. Patients receiving C.E.R.A. achieved a response rate of 93.3 percent versus 91.3 percent for epoetin alfa or beta, indicating C.E.R.A. was effective in correcting Hb levels with a once every two week dosing regimen. About the Phase III Clinical Trial Program

The C.E.R.A. phase III clinical trials were part of the largest initial registration program ever conducted for the treatment of renal anemia. The program consisted of two initiation/correction and four conversion/maintenance studies of both SC and IV C.E.R.A. at extended administration intervals. Initial findings from the Phase III 'maintenance studies,' were presented at the European Renal Association-European Dialysis and Transplant Association congress in July 2006. These results showed that, for the first time, patients with CKD on dialysis treated with short-acting and frequently administered epoetin anti-anemia drugs were successfully and directly switched to and stabilized with a treatment taken once every two weeks or once every four weeks.

Safety Information

C.E.R.A. was generally well tolerated. In the ARCTOS and AMICUS trials, the most frequently reported adverse events were hypertension and nasopharyngitis, and hypertension and procedural hypotension, respectively. Erythropoietic 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 C.E.R.A.

Roche's innovative investigational anti-anemia agent is the first continuous erythropoietin receptor activator. Its activity at the receptor sites involved in stimulating red blood cell production is different from that observed with traditional epoetin drugs.

Roche filed applications with the regulatory authorities in the United States and the European Union in April of this year seeking approval for use of the treatment in anemia associated with CKD in patients on dialysis and not on dialysis.

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 OlderWorkers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or www.roche.us.

-Note to the Editor:

Additional background information on anemia is available upon request

*The response rate is defined at achieving a Hb response (greater than or equal to 1 g/dL increase and less than or equal to 11 g/dL).

Hoffmann-La Roche Inc.

CONTACT: Linda Dyson of Roche, +1-973-986-5973, linda.dyson@roche.com, orDiana Scott of Manning Selvage & Lee, +1-917-723-6098,diana.scott@mslpr.com, for Roche

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