Oct 8 2009
Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that its wholly owned subsidiary, Labopharm Europe Limited, has completed a distribution and supply agreement with Grunenthal GmbH for its twice-daily tramadol acetaminophen formulation for a number of countries in Europe.
Under the terms of the agreement, Grunenthal has the exclusive right to market and sell Labopharm's twice-daily tramadol-acetaminophen formulation in a number of European countries. Labopharm will supply Grunenthal with unpackaged tablets and will receive a fixed transfer price inclusive of gross margin.
Labopharm will receive 3.5 million Euros on signature and up to 4 million Euros in milestone payments upon achievement of certain regulatory and product reimbursement approvals prior to the launch of the product.
"We are pleased to have established the first marketing partnership for our twice-daily tramadol-acetaminophen formulation," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "This agreement represents the initial step in the international commercialization plan for our tramadol-acetaminophen product. We are currently in discussion with Grunenthal to potentially expand our agreement to include additional European countries. We are also in discussion with other potential partners to conclude distribution and supply agreements for other jurisdictions around the world."
"We are enthusiastic to have the opportunity to commercialize Labopharm's innovative pharmaceutical formulation of one of our major brand Zaldiar," said Wolfgang Becker, Member of the Executive Board at Grunenthal and in charge of the worldwide Commercial Operations, "and we are convinced that prescribers will welcome this form for the benefit of their patients."
Labopharm is responsible for obtaining regulatory approval in most of the countries covered by the agreement. The Company is pursuing regulatory approval in Europe through the Mutual Recognition Procedure (MRP) and expects to submit its application for marketing authorization to the reference member state (RMS) before the end of 2009.
The estimated Euro sales in the countries covered by the agreement represent approximately 27% of the immediate release tramadol-acetaminophen combination products market in Europe, as per the last 12 months ending June, 2009.