Ipsen receives marketing authorization in France for its 6-month sustained-release formulation of Decapeptyl

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Ipsen (Paris:IPN), an innovation-driven global specialty pharmaceutical Group announces that the French regulatory authorities (Agence Française de Sécurité Sanitaire des Produits de Santé, AFSSAPS) have today granted the marketing authorization to the 6-month sustained-release formulation of Decapeptyl® (triptorelin embonate 22.5 mg) for the treatment of locally advanced and metastatic prostate cancer. The launch of the 6-month formulation of Decapeptyl® in France by Ipsen should take place during the first semester of 2010.

“Ipsen is pleased that the new 6-month formulation of Decapeptyl® will soon be available for patients in France suffering from prostate cancer. Its improved convenience comes with a consistent and similar efficacy and tolerance to the already established Decapeptyl®’s 1 and 3-month Decapeptyl® formulations,” said Etienne de Blois, Deputy General Manager, France Operations, Ipsen.

Triptorelin embonate 22.5 mg is a new 6-month-formulation of a luteinizing hormone releasing hormone (LHRH) agonist for the treatment of locally advanced or metastatic, hormone-dependent prostate cancer, developed by Debiopharm Group. Debiopharm has licensed the marketing rights to Ipsen for all territories where Ipsen currently commercializes triptorelin.

Last 13 October, Ipsen and Debiopharm Group announced the successful completion of the European decentralised registration procedure involving nine countries: Germany (reference member state), France, Austria, Finland, Norway, Belgium, Denmark, Spain and The Netherlands while for other European countries (Portugal, United Kingdom, Ireland, Italy, Romania and Lithuania), the marketing authorisation applications were filed as a national line extension to the existing Decapeptyl®’s ones. France is the first country to approve Decapeptyl® 6-month in the context of the Decentralized procedure in Europe.



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