Labopharm receives notification of regulatory approval in France for once-daily tramadol
French Approval Paves the Way for Commercial Launch Across Europe
Labopharm Inc. announced that it has received notification of regulatory approval for its once-daily formulation of tramadol from the French regulatory authority. The product has been approved with a once-daily designation for use in a dose range from 100 to 400 mg per day in the treatment of moderate to severe pain. Approval in France allows Labopharm to initiate the Mutual Recognition Procedure (MRP) in pursuit of regulatory approval for the remainder of the European Union countries.
Together with the French regulatory authority, Labopharm has been preparing its submission to initiate the MRP process for its once-daily tramadol product. In addition, the Company is working to obtain pricing and reimbursement approval in France. Labopharm is also working closely with each of its European partners to finalize preparations for commercial launch of its product.
The European market for tramadol is large and growing with sales for the 12-month period ended September 2004 exceeding US$570 million, representing a compound annual growth rate of 18% over the previous five 12-month periods. In France, the largest European market for tramadol, sales exceeded US$160 million for the 12-month period ended September 2004, representing a compound annual growth rate of 26% over the previous five 12-month periods.
As previously announced, Labopharm has licensing and distribution partners for its once-daily formulation of tramadol with Sanofi-aventis for France, with HEXAL AG for Germany, with Gruppo Angelini for Italy, with Esteve SA for Spain and Portugal and with CSC Pharma for a group of 13 Eastern European countries and Austria. Combined, the marketing partnerships cover approximately 80% of the total European market for tramadol, including four of the five largest national markets. The Company is in active discussions with potential partners for the remaining European markets, including the United Kingdom.
Other news from the department research and development
