hurray for generic tacrolimus 4/08

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> TOKYO, Feb 26 - Astellas Pharma Inc. Japan's third-largest drug maker,

> said on Monday a committee of the European Medicines Agency had

> recommended marketing approval of a once-daily version of its key

> transplant drug Prograf. The new formulation is a modified release

> version of Prograf which is used to prevent organ rejection in kidney,

> liver and heart transplants and is currently taken twice a day. Prograf

> is expected to account for 19 percent of Astellas' overall revenue this

> year, and gaining approval of the new formulation is key for the company

> to minimise the impact of generics when the drug's patent expires. The

> drug will come off patent in Europe in June 2009 and in the United

> States in April next year.

> In January, the U.S. Food and Drug Administration said it could not yet

> approve the new version of the drug for heart transplant patients and

> raised questions about its application for use of the drug in kidney and

> liver transplants. The " action letter " from the FDA will mean a delay

> of at least six months, at which point the agency will either approve

> the drug or send another letter requesting more information.

> Immunosuppressant drugs are different from other drugs in that the risk

> of organ rejection means doctors are more cautious about using generics,

> and analysts say any fall in profit would be gradual, giving Astellas

> more time to gain approval. Reuters 2007. All rights reserved.

>

> Reuters

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