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Ortho Biotech to Submit Official Request for Reconsideration to CMS Regarding ESA Coverage Policy
Date:11/8/2007

lobin

levels;

-- Recent product labeling reviews in the EMEA and in the United States;

-- New national practice guidelines;

-- Further information concerning ESA U.S. registration trials; and

-- Interim safety results of a large, randomized, placebo-controlled trial

in patients with advanced Hodgkin's disease undergoing chemotherapy.

Ortho Biotech believes that PROCRIT is safe and effective for the treatment of anemia in patients with most types of cancer receiving concurrent chemotherapy when used according to its FDA-approved prescribing information. Epoetin alfa has been studied for more than 20 years and used in four million patients worldwide for approved indications.

About PROCRIT (Epoetin alfa)

PROCRIT is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.

Important U.S. Safety Information for PROCRIT

Boxed WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events, and Tumor Progression

Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

Cancer:

-- ESAs shortened overall survival and/or time-to-tumor progression in

clinical studies in patients with advanced breast, head and neck,

lymphoid, and non-small cell lung malignancies when dosed to ta
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SOURCE Ortho Biotech
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