Healthcare Industry News:  erythropoietin receptor activator 

Biopharmaceuticals

 News Release - October 19, 2007

Pivotal MIRCERA(R) Study First to Convert Dialysis Patients From Frequent Dosing Directly to Once Every Two Weeks or Once Every Four Weeks

MAXIMA findings in The Lancet affirm the maintenance of hemoglobin levels with less frequent dosing

NUTLEY, N.J., Oct. 19 (HSMN NewsFeed) -- A pivotal study published today in The Lancet has shown that dialysis patients were effectively switched from frequently-dosed anemia drugs to an innovative investigational anemia treatment, MIRCERAŽ, administered up to once every four weeks(1)

The MAXIMA study is the first randomized, comparative study to investigate the direct conversion of dialysis patients with chronic kidney disease from treatment with erythropoiesis-stimulating agents (ESA) given one to three times a week to IV MIRCERA administered once every two weeks or once every four weeks. The results demonstrated that MIRCERA maintained hemoglobin (Hb) concentrations within the target range as effectively as ESAs epoetin alfa or beta, which are typically given three times a week.

"Our findings demonstrate that MIRCERA was administered up to once every four weeks in hemodialysis patients without sacrificing hemoglobin stability," said Nathan Levin, M.D., Medical and Research Director, Renal Research Institute, New York, New York, and the lead author of the publication. "We note in The Lancet that these results should be generalizable to the maintenance hemodialysis population and that we believe this drug should be an option to epoetin for simplified anemia management."

About the MAXIMA Study

The MAXIMA study randomized 673 adult patients with stable chronic renal anemia on dialysis therapy and IV maintenance epoetin at 91 centers in eight countries. Most patients were from North America (U.S. - 68 percent; Canada - 11 percent) and Europe (21 percent). The study compared two administration intervals of IV MIRCERA (once every two weeks or once every four weeks) with continued IV epoetin treatment (one to three-times a week) in patients with chronic renal anemia. After a run-in period, patients were randomly assigned to either of the MIRCERA arms or to continue epoetin alfa or beta at their current dose and administration interval. Patients randomized to MIRCERA received a starting dose based on the previous weekly dose of epoetin.

In contrast to previous studies in which dialysis patients were converted from IV epoetin using sequential increases in dosing intervals, most patients in MAXIMA were converted directly from a predominantly three-times-a-week regimen of epoetin (87 percent of patients) to IV MIRCERA administered once every two weeks or once every four weeks.

MAXIMA Study Findings

The MAXIMA results showed:

-- Minute changes in Hb levels throughout the duration of the study (mean changes from the baseline to the evaluation periods were -0.71, -0.25, and -0.75 g/L in the MIRCERA once every two weeks; MIRCERA once every four weeks and epoetin groups, respectively), illustrating that the primary efficacy parameter (mean change in Hb level between baseline and evaluation periods) was met.

-- For the secondary analysis, the proportion of patients maintaining a mean Hb within plus or minus 10 g/L of baseline was 68 percent, 68 percent, and 67 percent in the MIRCERA once every two weeks and MIRCERA once every four weeks and epoetin groups, respectively.

-- The most common serious adverse events in the three groups were sepsis, pneumonia and arteriograft thrombosis. A similar incidence of adverse events occurred across all treatment arms with the most frequent adverse events mild to moderate and had a distribution typical for this patient population.

About MIRCERA

The clinical program for MIRCERA consisted of 10 global studies involving more than 2,700 patients from 29 countries. The Phase III program for MIRCERA included two correction studies 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). In clinical trials MIRCERA corrected anemia in chronic kidney disease (CKD) patients with dosing once every two weeks and maintained hemoglobin levels in CKD patients with dosing intervals up to once monthly. In the U.S., the FDA is completing its review and MIRCERA is anticipated to be approved mid-November.

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.

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

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 2007 Roche was named Top Company of the Year by Med Ad News and one of the Top 20 Employers (Science magazine). In 2006, Roche was 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.

(1) N. W Levin, S. Fishbane, F. Valdes Canedo, S. Zeig, G. M Nassar, J. E Moran, G. Villa, U. Beyer, D. Oguey, on behalf of the MAXIMA study investigators. "Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA)." The Lancet, Vol 370, Pages 1415-1421. October 20, 2007


Source: Roche Group

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