Astellas gets EU approval for once-daily transplant drug

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Friday April 27, 2007

Astellas gets EU approval for

once-daily transplant drug

TOKYO,

April 27, 2007 - Astellas Pharma

Inc. , Japan's third-largest drug maker, said on Friday it had received

European approval to market Advagraf, 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 and is currently given twice a day. Advagraf

was approved for use in kidney and liver transplants. Gaining approval for Advagraf

was vital for Astellas to minimise

the impact of generics when Prograf's patent expires

in Europe in June 2009.

But

approval for Avagraf in the United States, where the patent expires in April next year, has been

delayed. The U.S.

Food and Drug Administration expressed concerns last month that the combination

of Prograf and an immunosuppressant drug from Roche

Holding AG could lead to a rise in infection-related deaths. 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.

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