Ipsen today announced that it has submitted a Biologics License Application (BLA) for Dysport® for Injection in cervical dystonia to the Food and Drug Administration (FDA) in the United States for the treatment of patients with cervical dystonia

PARIS, France | December 6, 2007 | Ipsen (Euronext: FR0010259150; IPN) today announced that it has submitted a Biologics License Application (BLA) for Dysport® for Injection in cervical dystonia to the Food and Drug Administration (FDA) in the United States for the treatment of patients with cervical dystonia.

In accordance with US regulations, the FDA will now be conducting a technical screening of the application to ensure that sufficient data and information have been submitted to justify the final review of the dossier by the Center for Drug Evaluation and Research.

Dysport® has been granted orphan product status by the FDA as a treatment for cervical dystonia, an orphan disease in the United States. The BLA submission relies on data from two pivotal Phase III studies performed in the United States and abroad totalling 252 patients followed-up for up to 12 treatment cycles, in addition to substantial patient exposure in other clinical studies in cervical dystonia.

SOURCE: IPSEN

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