Labopharm Inc. announced its twice-daily tramadol-acetaminophen has received a positive opinion under the European Union Decentralized Procedure in eight countries (Czech Republic, Iceland, Ireland, Poland, Portugal, Slovakia, Slovenia and Spain). Marketing Authorization will be granted in each country subject to the approval of translations of the Summary of Product Characteristics (SPC) and other labelling documents.

"European approval of our twice-daily tramadol-acetaminophen positions us for commercialization of our third product and we are working with our marketing partner, Grunenthal, towards launch in multiple European markets late next year," said James R Howard-Tripp, president and chief executive officer, Labopharm Inc.

Standard unit sales of tramadol-acetaminophen products (currently available only in immediate-release formulations) in these eight countries account for more than 25 per cent of sales of all tramadol-acetaminophen products Europe-wide. In addition, standard unit sales of tramadol-acetaminophen in these countries (excluding Iceland, for which data are unavailable) have grown at a compounded annual rate of 29 per cent for the last three 12-month periods ending June 30, making tramadol-acetaminophen combination products the fastest growing segment of the overall tramadol product market.

In October 2009, Labopharm established a licensing and distribution agreement with Grunenthal GMbH under which it granted Grunenthal the exclusive right to market and sell its twice-daily tramadol-acetaminophen in a number European countries, including the countries in which the product has been approved for sale (except Iceland). The Company is continuing to pursue partnership opportunities for other jurisdictions around the world.

The Decentralized Procedure (DCP) provides an efficient mechanism by which applicants can seek regulatory approval for a pharmaceutical product in multiple jurisdictions in the European Union (EU) simultaneously and is applicable in situations where marketing authorization does not yet exist in any of the EU Member States. Under the DCP, identical dossiers are submitted in all Member States where marketing authorization is sought. A Reference Member State (RMS), selected by the applicant, prepares a draft assessment, which it provides to the Concerned Member States (CMS). The CMS either confirm agreement with the assessment or disagree with the assessment, which results in arbitration procedures. Following successful completion of the DCP, the RMS and CMS each provide national marketing authorization, which permits marketing and sale in that jurisdiction.

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.

Grünenthal is passionate about globally being the preferred partner in pain management for patients, health care professionals, and payors. The corporation drives innovation to achieve global market leadership in the treatment of moderate to severe pain - directly and with partners.

Headquartered in Laval, Canada with US offices in Princeton, New Jersey, Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies.