Labopharm Europe Opens New Headquarters in Dublin, Ireland

22-Jan-2004

DUBLIN - Labopharm Europe Limited, a wholly owned subsidiary of Canada-based Labopharm Inc. , announced the official opening of its new head office in Dublin, Ireland. "With a critical mass of expertise in the speciality pharma sector, Dublin is the ideal location for Labopharm Europe's new headquarters," said James F.X. Fahy, Director, Labopharm Europe Limited. "We look forward to continuing to build relationships, both within the local pharmaceutical community and across Europe, as we work towards the European commercialisation of Labopharm's once-daily formulation of tramadol and build Labopharm's presence internationally." Labopharm is nearing commercialisation of its first product, a once-daily formulation of the analgesic tramadol. In Europe, tramadol is currently available in generic immediate-release formulations that require dosing up to six-times daily and branded sustained-release formulations that require twice- daily dosing. In January 2003, Labopharm reported the positive results of its European Phase III trial for its formulation of once-daily tramadol, which achieved both its primary and secondary end points. In March 2003, Labopharm initiated the regulatory approval process in Europe for once-daily tramadol, commencing the Mutual Recognition Procedure (MRP) with the submission of a marketing-authorization-application/order_t/'>Marketing Authorization Application (MAA) with regulatory authorities in France. Under the MRP, approval in France should facilitate rapid approval across the rest of the European Union and in many non-EU countries. "Labopharm Europe has played a key role in completing preparations for the market launch of once-daily tramadol in Europe," said Anthony C. Playle, Managing Director, Labopharm Europe Limited. "Over the longer-term, Labopharm Europe will be integral in our parent Company's development internationally towards its stated goal of becoming a fully integrated speciality pharmaceutical company." Labopharm Europe has been responsible for securing licensing and distribution agreements for once-daily tramadol in 18 European countries, including France (with Aventis France), Italy (with Gruppo Angelini), Spain and Portugal (with Esteve SA) and 14 Eastern European countries with CSC Pharmaceuticals. Labopharm Europe was established in 2002 to address the regulatory, marketing and supply chain management functions in the commercialisation of Labopharm Inc.'s products in Europe. Labopharm Europe is also responsible for Labopharm Inc.'s business development activities in Europe, including securing agreements to develop new products and exploring merger and acquisition opportunities.

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