LAVAL, QC, Nov. 6 /PRNewswire-FirstCall/ -- Labopharm Inc. (TSX: DDS) today announced that, through its European subsidiary, Labopharm Europe Limited, it has secured a licensing and distribution agreement with Austria- based CSC Pharmaceuticals Handels GmbH for 14 Eastern European countries for its lead in-house product, a once-daily version of the analgesic tramadol.
"With this agreement, we have now secured marketing partnerships for our once-daily formulation of tramadol for 18 countries in Europe, including three of the five largest pharmaceutical markets," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "The countries covered by this partnership comprise more than 16% of the European population, representing a sizeable market opportunity for once-daily tramadol. We are confident that, with its strong market presence and regulatory expertise in Eastern Europe, CSC will maximize the commercial opportunity inherent in our once-daily formulation of tramadol. As part of our global commercialization plan, we continue to actively pursue marketing partners for other key European markets, the United States and other key markets globally."
Under terms of the binding Letter of Intent, Labopharm has granted CSC the exclusive right to market and sell the Company's once-daily formulation of tramadol in Austria, Bulgaria, Chechnya, Croatia, Estonia, Federal Republic of Yugoslavia (Serbia and Montenegro), Hungary, Latvia, Lithuania, Macedonia, Poland, Romania, Slovakia and Slovenia. Labopharm will earn a share of revenue from product sales. Labopharm will supply CSC with product through Labopharm Europe Limited.
The Mutual Recognition Procedure (MRP), which Labopharm initiated in March 2003 using France as the Reference Member State (RMS) will facilitate regulatory approval in European Union (EU) member and candidate countries (Austria, Bulgaria, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia and Slovenia). For the remaining countries covered by the marketing agreement, Labopharm, together with CSC, will initiate the regulatory approval process on a country-by-country basis.
Labopharm has previously secured licensing and distribution agreements for once-daily tramadol with Aventis France for France, Gruppo Angelini for Italy, and Esteve SA for Spain and Portugal.
Labopharm's Development Program for Once-Daily Tramadol
Labopharm is pursuing parallel initiatives in Europe and the United States in developing once-daily tramadol. In March, Labopharm initiated the regulatory approval process in Europe for its once-daily formulation of tramadol, commencing the Mutual Recognition Procedure (MRP) with the submission of a Marketing Authorization Application (MAA) with regulatory authorities in France. In the U.S., Labopharm conducted two double-blind, multi-centre, randomized trials to evaluate the full 24-hour efficacy and safety of its once-daily formulation of tramadol in reducing moderate to moderately severe pain in patients suffering from osteoarthritis. The subject population of the trials, which were conducted at more than 100 centres, includes more than 1,000 men and women aged 40 to 75. Following extensive consultation with the FDA, the protocols for the two U.S. pivotal trials were tailored to meet that organization's requirements for extended-release analgesics. The data from these trials will be combined with data from the previously completed European regulatory submission to form the basis of the Company's NDA submission. To date, Labopharm has treated approximately 1,800 patients in various clinical studies as part of its international once-daily tramadol program.
Tramadol is a centrally acting analgesic indicated for moderate to moderately severe pain that may be associated with conditions such as osteoarthritis, lower back spasm, cancer, and other acute and chronic conditions. Because tramadol is well tolerated compared to anti-inflammatory drugs, it can be used by patients who are at risk of developing gastrointestinal bleeding and those with kidney problems. Tramadol reduces pain by binding to u-opioid receptors and by inhibiting the re-uptake of the neurotransmitters norepinephrine and serotonin, a unique advantage over other analgesics. The worldwide market for tramadol is estimated to be in excess of US$1 billion annually.
About CSC Pharmaceuticals Handels GmbH
CSC Pharmaceuticals is a private multinational pharmaceutical company with more than 550 employees operating regionally, primarily in Central and Eastern Europe. The Company has a portfolio of more than 50 products covering multiple therapeutic areas. CSC's partners include such international pharmaceutical companies Alfa Wasserman, Gruppo Angelini, Chiron, Fidia, Formenti-Grunenthal, Pharmasciences and Recordati. Italy-based Groppo Angelini holds a significant equity stake in CSC.
About Labopharm Inc.
Labopharm Inc. (TSX:DDS) is an international specialty pharmaceutical company focused on the development of drugs incorporating the Company's proprietary advanced controlled-release technology, Contramid(R). Contramid(R) can be applied to a wide variety of drugs in solid oral dosage form, improving their oral administration and performance and is used to develop products that are either bio-equivalent to existing, branded products, or are new branded products. Labopharm's lead in-house product, a once-daily formulation of the analgesic tramadol, is under regulatory review in Europe and through the treatment stage of pivotal Phase III clinical trials in the US. The Company's pipeline includes a combination of both in-house and partnered programs with four products in clinical trials and another four undergoing preclinical development. Labopharm is also developing implantable mini-tablets based on Contramid(R) for local administration of drugs and novel nano-carrier systems using polymeric micelles for both systemic and targeted delivery of water- insoluble drugs. For more information, please visit http://www.labopharm.com/.
This press release contains forward-looking statements, which reflect the Corporation's current expectations regarding future events. The forward- looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the successful and timely completion of clinical studies, the uncertainties related to the regulatory process and the commercialization of the drug thereafter. Investors should consult the Corporation's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Corporation disclaims any obligation to update these forward-looking statements.