Labopharm licenses tramadol in U.S., keeping launch on track for late 2006

By Angela McDaniels

Seattle, Nov. 3 - Labopharm Inc. said it has reached an agreement that will help expedite the commercialization of its once-daily tramadol product, Tramadol OAD, in the United States.

Tramadol is a centrally acting synthetic opioid analgesic, effective in the treatment of pain.

Labopharm, together with its U.S. marketing and distribution partner Purdue Pharma Products LP, has agreed to grant a license to Ortho-McNeil Inc. under certain Purdue patents covering extended-release tramadol formulations.

As a result, Labopharm has secured the right to a waiver, allowing the U.S. Food and Drug Administration to grant approval of Labopharm's Tramadol OAD based on its merits, notwithstanding the three-year Hatch-Waxman exclusivity period granted to Ortho-McNeil's extended release formulation of tramadol, recently licensed from Biovail Corp.

Under the agreement between Ortho-McNeil and Biovail, which has a 10-year term, Biovail will manufacture, supply and sell the drug to Ortho-McNeil for distribution at contractually determined prices, which will be based on Ortho-McNeil's net selling price.

The supply prices go up to 37.5% of Ortho-McNeil's net selling price, depending on the year of sale, peaking in 2007 and beyond. Upon closing of the transaction, Ortho-McNeil will pay to Biovail a supply prepayment of $60 million to be credited against product purchases of the drug.

Labopharm will also receive a right of reference to Ortho-McNeil's previously filed tramadol data.

"We remain on track to file an NDA by the end of the year and anticipate being in a position to launch our once-daily tramadol product in the U.S. as early as the fourth quarter of 2006 subject to a successful review by the FDA," said James R. Howard-Tripp, president and chief executive officer of Labopharm, in a company press release.

Labopharm is a pharmaceutical company based in Laval, Quebec that develops drugs incorporating Contramid, the company's controlled-release technology.

Biovail is a pharmaceutical company based in Toronto that develops pharmaceutical products utilizing advanced drug-delivery technologies.

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