Labopharm Initiates Regulatory Approval Process for Twice-DailyTramadol-Acetaminophen in Europe

Thu, 12/17/2009 - 3:39am
Labopharm Inc. today announced it has initiated the regulatory approval processfor its twice-daily tramadol-acetaminophen formulation in Europe under theDecentralized Procedure (DCP). The DCP provides an efficient mechanism thatallows a company to simultaneously pursue regulatory approval for a medicinalproduct in multiple jurisdictions in Europe. "Initiating the regulatory approval process in Europe builds on ourrecently established marketing partnership with Grunenthal GmbH," said JamesR. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "It isour intention to commercialize our twice-daily tramadol-acetaminophenformulation in key markets around the world. To this end, we are bothpreparing to submit additional regulatory applications in 2010 and pursuingmarketing partners in key regions around the world." In accordance with the DCP, Labopharm has submitted a marketingauthorization application (MAA) with a Reference Member State (Iceland), whichwill provide an assessment of the MAA file to the Company's list of ConcernedMember States. Labopharm is responsible for obtaining regulatory approval inmost of the countries included in the distribution and supply agreement withGrunenthal and is seeking approval in those countries. The regulatoryauthorities of both Reference Member State and Concerned Member States willachieve consensus regarding approval of the product and all Member Statesgrant national Marketing Authorisations based upon that consensus decision.The DCP is expected to take approximately one year to complete and nationalMarketing Authorizations will be provided thereafter.

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