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Pronova BioPharma announces Strategic Supply Agreement for a Fixed Dose Combination Product with Omacor and Simvastatin

Pronova BioPharma ASA today announces that its subsidiary Pronova BioPharma Norge AS has entered into a strategic supply agreement with Defiante Farmacêutica SA, a subsidiary of the Italian sigma-tau group, for the exclusive supply of the active pharmaceutical ingredient (API) for a fixed dose combination product with Omacor and simvastatin in Spain, France and Portugal, with a possibility to add other countries upon prior written agreement.

Clinical trials of the fixed dose combination product have been completed. Initial discussions with regulatory authorities in Europe have taken place. The fixed dose combination product could come to the market in 2011, contingent upon regulatory approvals and collaboration with Pronova BioPharma's existing pharmaceutical partner network in said European countries.

Associated companies: