Labopharm Inc. today announced that its once-daily tramadol product has received regulatory approval from the Korea Food and Drug Administration, which allows for the marketing and sale of Labopharm's once-daily tramadol product in South Korea, and from the Australian Department of Health and Aging, which allows for the marketing and sale of Labopharm's once-daily tramadol product in Australia.
"Approval in South Korea and Australia brings the number of countries in which our product has been approved to 27," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "South Korea and Australia are important components of the global commercialization plan for our product. We are now working with our marketing partners in both countries towards the launches of our product later this year."
Labopharm completed licensing and distribution agreements for its once-daily tramadol product for South Korea with WhanIn Pharmaceutical Co., Ltd last year, and for Australia with iNova Pharmaceuticals (Australia) Pty Limited earlier this year. The Company expects its product to be launched in South Korea and Australia later this year.
Marketing Partnership for Once-Daily Tramadol for Turkey
Labopharm also announced today that it has signed a licensing and distribution agreement for its once-daily tramadol product for Turkey with Dr. F. Frik Ilac San. Ve Tic. A. S.
Under terms of the agreement, Dr. F. Frik will have the exclusive right to market and sell Labopharm's once-daily tramadol product in Turkey. Labopharm will supply Dr. F. Frik with finished packaged product and will receive revenue from the sale of such finished packaged product at rates commensurate with those of previous licensing and distribution agreements that Labopharm has entered into for other European markets. Labopharm is also eligible to receive additional payments upon the achievement of certain milestones.
Labopharm has submitted a marketing application for regulatory approval of its once-daily formulation of tramadol to the Ministry of Health in Turkey. The Company expects to receive approval in early 2009.
For the 12-month period ended September 2007, sales of tramadol products in Turkey were 7.1 million standard units, representing a compounded annual growth rate over the previous five 12-month periods of 35%.