- National Marketing Authorizations Expected in Due Course/Marketing Partner Grunenthal Preparing to Launch in Multiple European Markets Late Next Year -
Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today 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 labeling 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% 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% 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.