Roche's CERA alleviates anemia in phase 3 studies

By Angela McDaniels

Seattle, Dec. 16 - Hoffmann-La Roche Inc. said the four maintenance studies of its phase 3 renal program for anti-anemia agent CERA have met their primary endpoints: both intravenous and subcutaneous CERA were effective in maintaining hemoglobin levels when given at extended dosing intervals.

The goals of the phase 3 program were to confirm the efficacy of CERA at extended administration intervals for the correction of anemia and the maintenance of hemoglobin levels and to demonstrate its long-term safety and tolerability.

Correction is a term describing the initial phase of treatment for renal patients who have been diagnosed with anemia but have not previously received treatment with an erythropoiesis-stimulating agent to increase their hemoglobin level. Maintenance refers to keeping corrected hemoglobin levels in a defined range over time.

Over 2,700 patients on dialysis and on stable maintenance treatment of anemia with epoetin or darbepoetin were randomized to continue their treatment or switch to CERA given once every two weeks or once every four weeks.

Generally, the safety profile was characteristic of the population under study, the company said.

The full review of the benefit-risk assessment of CERA will be made by the Health Authorities after filing in 2006.

"The completion of the four CERA phase 3 maintenance studies is an important milestone in CERA's history, as we move forward with the Biologics License Application with expected filing with the U.S. Food and Drug Administration in 2006," vice president of operations Richard Hinson said in company news release.

"CERA's unique ability to provide up to once monthly dosing may potentially offer a convenient and efficacious treatment option for patients with anemia in all stages of chronic kidney disease."

The final two studies examining correction of anemia in patients with chronic kidney disease on dialysis and not on dialysis are nearing completion, the company said.

The activity of CERA at the receptor sites involved in stimulating red blood cell production is different from what has been observed for erythropoietin, the company said, and this distinct molecular interaction is believed to have an essential role in providing targeted, stable and sustained control of anemia.

Anemia refers to patients who have a lower-than-normal level of red blood cells or hemoglobin. Hemoglobin enables red blood cells to carry oxygen throughout the body, and a lack of oxygen causes extreme fatigue, dizziness, pale skin and other symptoms.

Normally, when the body senses a decrease in oxygen, more erythropoietin (a protein produced by the kidneys) is created. This protein stimulates the production of oxygen-carrying red blood cells in the bone marrow which raises the red blood cell count. When this natural mechanism is hindered, as in patients with kidney disease, it is necessary to stimulate the receptors in the bone marrow to produce red blood cells with agents such as CERA, which will be the first - and only - continuous erythropoietin receptor activator, the company said.

Roche develops pharmaceuticals and diagnostics and has headquarters in Basel, Switzerland.

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