NUTLEY, N.J., Dec. 16 /PRNewswire/ -- Roche, a world leader in biotechnology, today announced that all four maintenance studies of the pivotal phase III renal program for its unique long-acting anti-anemia agent, CERA, have been successfully completed. CERA is the first and only Continuous Erythropoietin Receptor Activator and the only anti-anemia drug to have ever studied long-dosing intervals of once every four weeks for its initial filing.
The final two studies examining correction of anemia in patients with chronic kidney disease on dialysis and not on dialysis are nearing completion.
In these maintenance studies, 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. The maintenance studies met their primary endpoints and showed that both intravenous and subcutaneous CERA, when given at extended dosing intervals was effective in maintaining Hb levels. Generally, the safety profile is characteristic of the population under study. The most common adverse events in all treatment groups were infections, injuries and procedural complications, and gastrointestinal disorders. The full review of the benefit-risk assessment of CERA will be made by the Health Authorities after filing in 2006.
The goals of the phase III program were to confirm the efficacy of CERA at extended administration intervals for the correction of anemia and the maintenance of Hb levels, and to demonstrate its long-term safety and tolerability. The Phase II-III program is the largest program ever undertaken for a drug treating anemia, and involving more than 2,700 patients from 29 countries.
“The completion of the four CERA phase III maintenance studies is an important milestone in CERA’s history, as we move forward with the Biologics License Application (BLA) with expected filing with the U.S. Food and Drug Administration in 2006,” said Richard Hinson, Vice President, Operations, Hoffmann-La Roche, Inc. “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.”
About the Study
The Phase III study program consisted of two correction and four maintenance studies. Correction is a term that is used to describe 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 Hb level. Maintenance refers to keeping Hb levels in a defined range over time in patients whose Hb levels have been corrected.
In the four maintenance studies, the primary endpoint was the change in hemoglobin (Hb) concentration between baseline and the evaluation period:
- The first study was designed to evaluate IV CERA in the maintenance of Hb levels in CKD patients on dialysis previously maintained on IV epoetin. IV epoetin was dosed up to three times weekly compared to CERA dosed once every two weeks or once every four weeks.
- The second study was designed to evaluate SC CERA in the maintenance of Hb levels in CKD patients on dialysis previously maintained on SC epoetin. SC epoetin was administered up to three times weekly, compared to CERA dosed once every two weeks or once every four weeks.
- The third study was designed to evaluate IV CERA in the maintenance of Hb levels in CKD patients on dialysis previously maintained on IV darbepoetin alfa. Darbepoetin alfa was dosed once a week or once every two weeks compared to CERA dosed once every two weeks.
- The fourth study was designed to evaluate SC or IV CERA in a pre-filled syringe in the maintenance of Hb levels in patients on dialysis previously maintained on epoetin. Epoetin was administered up to three times weekly compared to CERA administered once every two weeks.
About CERA CERA is a new drug under development for the treatment of anemia in chronic kidney disease patients. It is the first and only Continuous Erythropoietin Receptor Activator. This means that the activity of CERA at the receptor sites involved in stimulating red blood cell production is different from what has been observed for erythropoietin, and this distinct molecular interaction is believed to have an essential role in providing targeted, stable and sustained control of anemia.
About Anemia
Anemia is a complication associated with CKD patients from those with early stage illness to those with kidney failure requiring dialysis. Anemia refers to patients experiencing a lower than normal level of red blood cells or the hemoglobin in them. Hemoglobin enables red blood cells to carry oxygen throughout the body and therefore, when the body is starved of the oxygen it requires, extreme fatigue sets in along with dizziness, pale skin and other symptoms. Other serious clinical complications will appear as the body works harder to compensate for the lack of oxygen.
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.
About Roche - More Than a Century in the U.S. and the World
Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is one of the world’s leaders in diagnostics, the leading supplier of pharmaceuticals for cancer, as well as a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on many fronts to improve people’s health and quality of life. Roche’s U.S. operations celebrate their American Centennial in 2005. In another milestone this year, Roche was named in January to Fortune magazine’s list of Best Companies to Work for in America. One of an increasingly rare breed of major healthcare companies that still bear their original name, Roche today has more than a dozen U.S. sites located in California, Colorado, Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche’s Pharmaceuticals Division offers a portfolio of leading medicines in therapeutic areas including cancer, HIV/AIDS, hepatitis C, transplantation, dermatology and influenza. Roche’s Diagnostics Division supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our worldwide and U.S. websites (Global: www.roche.com and U.S.: www.roche.us).
Source: Roche
