Ortho Biotech Inc. announced that its recombinant humanerythropoietin (epoetin alfa), sold as Procrit, has beenapproved by FDA for treating anemia caused by chemotherapyin patients with non-myeloid malignancies.

In clinical studies, Procrit decreased blood transfusionrequirements and their related risks after the first month oftherapy and increased hematocrit levels in anemic cancerpatients undergoing chemotherapy. The placebo-controlleddouble-blind trials involved 131 anemic cancer patients onchemotherapy.

The only adverse side effects of the Procrit therapy, accordingto Ortho, were edema and diarrhea.

Epoetin alfa is manufactured by Amgen Inc. (NASDAQ:AMGN),its discoverer. Amgen of Thousand Oaks, Calif., markets epoetinalfa as Epogen for treating chronic renal failure patients ondialysis.

Ortho Biotech markets and distributes the drug as Procrit fortreating all non-dialysis indications under a license fromAmgen to Ortho Pharmaceutical for the U.S. rights to the drugfor indications, excluding dialysis and diagnostics. Theseinclude chronic renal failure patients not yet on dialysis and fortreating anemia in AZT-treated, HIV-infected patients. OrthoPharmaceutical is a division of Johnson & Johnson, as is OrthoBiotech of Raritan, N.J.

Ortho conducted the clinical trials for the cancer indication, and"coordinated with Amgen" to submit the information to FDA.Amgen actually submitted the data as an amendment to itsoriginal product license application (PLA) on the drug,explained Sarah Colamarino, Ortho's manager of public affairs.FDA approved the amendment April 1, Colamarino toldBioWorld.

Epoetin alfa has orphan drug status for treating the anemiasassociated with chronic renal failure (including patients ondialysis and not on dialysis) and AZT-treated HIV-infectedpatients.

-- Jennifer Van Brunt Senior Editor

(c) 1997 American Health Consultants. All rights reserved.

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