PHARMACY

Watson, Natco ink deal for generic Revlimid

BY Alaric DeArment

MORRISTOWN, N.J. — U.S. generic drug maker Watson Pharmaceuticals and Indian drug maker Natco Pharma will work together to develop and commercialize a generic drug used for bone marrow disorders, the two companies said Tuesday.

The agreement concerns lenalidomide tablets in the 5-mg, 10-mg, 15-mg and 25-mg strengths. The drug is a generic version of Celgene’s Revlimid, used to treat the plasma cell cancer multiple myeloma and myelodysplastic syndrome. Myelodysplastic syndrome results from the bone marrow producing blood cells that are misshapen.

Under the agreement, the companies will share net profits. The companies said Natco may be the first company to apply for Food and Drug Administration approval, which would give the companies 180 days of market exclusivity once the agency approves the application.

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Bristol-Myers Squibb seeks additional approval for Orencia

BY Alaric DeArment

PRINCETON, N.J. — The Food and Drug Administration has accepted for review a supplemental approval application for an arthritis drug made by Bristol-Myers Squibb, the drug maker said Monday.

Bristol is seeking approval for Orencia (abatacept) injected into the skin as a treatment for adults with moderate to severe rheumatoid arthritis. The drug already is approved for intravenous injection.

The company filed the application in October after a phase-3 trial program of 1,847 patients showed that patients receiving weekly skin injections of the drug showed about the same degree of improvement as those receiving the drug by IV.

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Under PEPFAR, Matrix gets tentative approval for Ziagen generic

BY Alaric DeArment

PITTSBURGH — The Food and Drug Administration has given tentative approval to a generic drug for HIV/AIDS made by Mylan subsidiary Matrix Labs for distribution in developing countries under the President’s Emergency Plan for AIDS Relief, Mylan said Tuesday.

The tentative approval under PEPFAR covers Matrix’s abacavir sulfate tablets in the 60-mg strength. The drug is a generic version of ViiV Healthcare’s Ziagen, and is used to treat the disease in children.

“This approval is particularly important because it adds to the available treatment options for children who are living with HIV/AIDS in developing countries,” Mylan president Heather Bresch said. “The addition of abacavir to Mylan and Matrix’s HIV/AIDS antiretroviral franchise is a critical next step in helping to extend and improve the quality of life of people living with HIV/AIDS, and to continue to expand access to high-quality, affordable ARVs.”

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