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Prograf generic launched in the US

Astellas loses ground in the US as Sandoz launches generic equivalent of leading transplant drug

Sandoz, the generic manufacturing arm of Novartis, has launched a generic version of Astellas Pharma's transplant product Prograf in the US, threatening sales of the Japanese firm's most lucrative drug.

Prograf is the world's biggest selling immunosuppressant treatment used to help prevent rejection of a kidney or liver and accounts for 20 per cent of product sales at Astellas.

Sandoz is the first company to launch generic Prograf (tacrolimus) in the US following patent expiry in April 2008. The launch increases the breadth of Novartis' portfolio of immunosuppressants, which is already the largest in the market.

Astellas shares fell 4.9 per cent on the news, with analysts forecasting a 10 per cent to 20 per cent drop in sales of Prograf annually from this year. Shares also sank after the US Food and Drug Administration (FDA) denied the company's Citizen Petition, which was filed in September 2007, to ensure the safe and effective use of oral immunosuppressants used in organ transplant patients.

In the petition, Astellas requested that bioequivalence clinical trials in transplant patients be required for approval of substitute critical dose immunosuppressants. The company also asked that labelling changes be made to ensure that prescribing doctors are notified if substitution of another oral immunosuppressant is being considered by the pharmacist.

Astellas Pharma US plans to file a complaint in the US District Court in Washington DC, challenging the FDA's decision.

12th August 2009


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