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Biopharmaceuticals

 News Release - July 16, 2006

C.E.R.A. Anti-Anemia Drug Maintained Stable Hemoglobin Levels in Dialysis Patients With Up to Once Every Four Week Dosing in Phase III Clinical Studies

First Public Presentation of Phase III Data From Largest Ever Renal Anemia Clinical Development Program

NUTLEY, N.J., July 16 (HSMN NewsFeed) -- Dialysis patients treated with short-acting and frequently administered epoetin were switched to a once every two week or once every four week treatment and maintained stable hemoglobin (Hb) levels, according to data presented today. (1,2) This new treatment is Roche's investigational Continuous Erythropoietin Receptor Activator (C.E.R.A.) and the up to once every four week dosing approach in patients on dialysis - never before studied in Phase III initial registration trials - is a milestone in anemia management.

The results of three Phase III 'maintenance' studies - part of the largest clinical development program ever undertaken for a drug treating renal anemia - were presented at the annual meeting of the European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) in Glasgow, Scotland. These included two studies using epoetin alfa/beta as a comparator and one study using darbepoetin alfa. (1,2,4)

"This was the first Phase III study for its initial registration that examined a once every four week dosing interval. We were gratified to see that C.E.R.A. maintained stable hemoglobin levels during the evaluation and extended phases in these dialysis patients," said Dr. Nathan Levin, Medical and Research Director of the Renal Research Institute, New York and one of the lead investigators who presented the results of the first study. "Hemoglobin plays an important role in improving physical function and reducing the likelihood of heart disease, but maintaining stable hemoglobin levels can be a clinical challenge. These results with C.E.R.A. indicate the therapy may be a major step forward in the practical treatment of anemia."

Roche filed applications with the regulatory authorities in the United States and the European Union in April based in part on this data. Results from the remaining Phase III correction studies will be announced later this year.

About the Phase III Maintenance Studies

The primary objective of the three multi-center, Phase III maintenance studies was to demonstrate that intravenous (IV) or subcutaneous (SC) C.E.R.A. can maintain Hb concentrations in dialysis patients on prior epoetin alfa/beta or darbepoetin alfa therapy. (1,2,4) This is important as these studies involved directly converting or switching patients from very frequent therapy to either a once every two week or once every four week regimen. (1,2,4)

In these maintenance studies (which refers to keeping Hb levels in a defined range over time in dialysis patients whose Hb levels have been corrected), patients were randomized to continue their frequent treatment or convert directly to C.E.R.A. given once every two weeks or once every four weeks. (1,2,4) The primary endpoint was the mean change in Hb between baseline and the evaluation period. In these trials, dosage was adjusted to maintain Hb (plus or minus) 1.0 g/dL of the baseline level. (1,2,4) These studies are termed 'non-inferiority' studies, which means they were designed to prove a new investigational drug is not inferior to an existing therapy.

The data from these studies showed that both IV and SC administration of C.E.R.A. every two weeks or every four weeks maintained hemoglobin levels in dialysis patients who were converted from epoetin alfa or beta at more frequent doses. In addition data from an IV study demonstrated that C.E.R.A. administered once every two weeks maintained hemoglobin levels in dialysis patients who were converted from darbepoetin alfa. Specifically:

- The first study was designed to evaluate IV C.E.R.A. dosed once every two weeks or once every four weeks in the maintenance of Hb levels in dialysis patients previously maintained on IV epoetin alfa/beta dosed up to three times weekly. (1) Close to 90 percent of patients were receiving a three-time weekly dose of epoetin at the time they were converted. (1) The difference between IV C.E.R.A. dosed once every two weeks and epoetin in the mean change in Hb was 0.004g/dL. The difference between IV C.E.R.A. dosed once every four weeks and epoetin in the mean change in Hb was 0.05g/dL. These results demonstrate that IV C.E.R.A. whether dosed once every two weeks or once every four weeks was as effective as IV epoetin in maintaining Hb levels (p<0.0001). (1)

- The second study mirrored the first but evaluated SC C.E.R.A. at the same dosing intervals and in a patient population previously maintained on SC epoetin alfa/beta. (2) The trial found that the difference between SC C.E.R.A. dosed once every two weeks and epoetin in the mean change in Hb was 0.14g/dL. The trial found that the difference between SC C.E.R.A. dosed once every four weeks and epoetin in the mean change in Hb was - 0.02 g/dL. These results demonstrate that SC C.E.R.A. whether dosed once every two weeks or once every four weeks was as effective as SC epoetin in maintaining Hb levels(p<0.0001). (2)

- The third study was designed to evaluate IV C.E.R.A. dosed once every two weeks in the maintenance of Hb levels in dialysis patients previously maintained on IV darbepoetin alfa. (3) Darbepoetin alfa was dosed once a week or once every two weeks. (3) The difference between once every two weeks IV C.E.R.A. and darbepoetin alfa in the mean change in Hb was 0.18g/dL. These results demonstrate that IV C.E.R.A. once every two weeks was as effective as IV darbepoetin alfa in maintaining Hb levels (p<0.0001).

Safety Information The most frequent adverse events, which were similar between the treatment arms, were diarrhea, nasopharyngitis, hypertension, procedural hypotension or influenza. Erythropoetic 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 (C.E.R.A.). Its activity at the receptor sites involved in stimulating red blood cell production is different from that observed with traditional epoetin drugs.

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.

REFERENCES:

1. N. Levin, S. Fishbane, S. Zieg, G. Nassar, J. Moran, G. Villa, F. Dougherty. Poster Submitted to EDTA. Intravenous (IV) C.E.R.A. (Continuous Erythropoietin Receptor Activator) Administered Once Every 2 Weeks Or Once Monthly Maintains Haemoglobin (Hb) Levels in Patients With Chronic Kidney Disease, 2006, Glasgow, Scotland.

2. W. Sulowicz, F. Locatelli, J. Balla, B. Csiky, C. Rikker, J. Aldigier, F. Dougherty. Poster Submitted to EDTA. Subcutaneous (SC) C.E.R.A. (Continuous Erythropoietin Receptor Activator) Administered Once Every 2 Weeks or Once Monthly Maintains Haemoglobin (Hb) Levels in Patients with Chronic Kidney Disease (CKD) on Dialysis, 2006, Glasgow, Scotland.

3. National Kidney Foundation: K/DOQI Clinical Practice Guidelines: 2000 Update.

4. B. Canaud, J. Braun, F. Locatelli, G. Villa, B. Vlem, D. Guajardo, F. Dougherty. Intravenous (IV) C.E.R.A. (Continuous Erythropoietin Receptor Activator) administered once every 2 weeks maintains stable haemoglobin (Hb) levels in patients with chronic kidney disease (CKD) on dialysis, 2006, Glasgow, Scotland.


Source: Roche

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