Labopharm Inc. 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.
Tramadol-acetaminophen products leverage the unique but complementary modes of action of each of the active ingredients to provide the analgesic strength of a mild opioid (tramadol) and the rapid pain relief of acetaminophen. Tramadol-acetaminophen combination products were first launched in 2001 in the United States and in 2003 in other major markets around the world.
Labopharm's unique formulation of tramadol-acetaminophen is based on its Contramid controlled-release technology, which provides patients with both rapid pain relief and analgesic strength in a sustained-relief analgesic. The company's twice-daily formulation of tramadol-acetaminophen is designed to provide improved patient benefit by controlling the release of the two active ingredients simultaneously, thereby providing both immediate and sustained relief of acute pain.
Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The company's lead product, a unique once-daily formulation of tramadol, is now available in 17 countries around the world, including the US, Canada, major European markets and Australia.