- Procedure Provides Efficient Mechanism to Pursue Approval in Multiple Jurisdictions -
Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced it has initiated the regulatory approval process for its twice-daily tramadol-acetaminophen formulation in Europe under the Decentralized Procedure (DCP). The DCP provides an efficient mechanism that allows a company to simultaneously pursue regulatory approval for a medicinal product in multiple jurisdictions in Europe.
"Initiating the regulatory approval process in Europe builds on our recently established marketing partnership with Grunenthal GmbH," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "It is our intention to commercialize our twice-daily tramadol-acetaminophen formulation in key markets around the world. To this end, we are both preparing to submit additional regulatory applications in 2010 and pursuing marketing partners in key regions around the world."
In accordance with the DCP, Labopharm has submitted a marketing authorization application (MAA) with a Reference Member State (Iceland), which will provide an assessment of the MAA file to the Company's list of Concerned Member States. Labopharm is responsible for obtaining regulatory approval in most of the countries included in the distribution and supply agreement with Grunenthal and is seeking approval in those countries. The regulatory authorities of both Reference Member State and Concerned Member States will achieve consensus regarding approval of the product and all Member States grant national Marketing Authorisations based upon that consensus decision. The DCP is expected to take approximately one year to complete and national Marketing Authorizations will be provided thereafter.
The estimated Euro sales in the countries in which Labopharm is seeking regulatory approval represent 23% of the immediate release tramadol-acetaminophen combination products market in Europe for the 12-month period ending September 30, 2009.
SOURCE Labopharm Inc.