Labopharm Signs Agreement With Grunenthal

Labopharm has reported that its wholly-owned subsidiary, Labopharm Europe has completed a distribution and supply agreement with Grunenthal for its twice-daily tramadol acetaminophen formulation.

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.

Reportedly, Labopharm will supply Grunenthal with unpackaged tablets and will receive a fixed transfer price inclusive of gross margin.

Labopharm will receive E3.5m on signature and up to E4m in milestone payments upon achievement of certain regulatory and product reimbursement approvals, prior to the launch of the product.

Moreover, 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 authorisation to the reference member state (RMS) before the end of 2009.

James Howard-Tripp, president and CEO at Labopharm, said: “We are pleased to have established the first marketing partnership for our twice-daily tramadol-acetaminophen formulation. 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.”