LABOPHARM AND PURDUE WILL MARKET TRAMADOL

Labopharm has entered into a U.S. distribution and licensing agreement with Purdue Pharma for a once-daily version of Ortho-McNeil Pharmaceutical's analgesic drug tramadol. Labopharm said it plans to submit its new drug application (NDA) to the FDA later this year.

Tramadol, which Ortho-McNeil markets as Ultram (tramadol HCl) and Ultracet (tramadol HCl/acetaminophen), is used to treat moderate to moderately severe pain in adults. Ortho-McNeil's patent on the drug is set to expire in August 2011.

The deal between Connecticut-based Purdue and Canadian drug firm Labopharm, which specializes in controlled-release generics, means they are now poised to fill a gap in the U.S. market for controlled-release tramadol.

Labopharm's Canadian competitors Biovail and Cipher Pharmaceuticals also have extended-release versions of tramadol in the works, but the FDA has put Biovail's NDA for an extended-release tramadol product on hold pending a six-month FDA review, while Cipher hasn't yet submitted an NDA to the agency. Biovail and Cipher haven't yet secured partnerships to sell tramadol products on the U.S. market.

Under terms of the agreement, Purdue will pay Labopharm up to $170 million including a $20 million licensing fee, a payment of up to $40 million upon approval and payments contingent upon meeting certain sales targets. Purdue will also bear the costs of hiring, training and compensating Labopharm's sales force.

Labopharm is already on the verge of having its once-daily dose tramadol product approved in Europe, where it has secured marketing partnerships in 20 countries. The company told FDAnews it anticipates launching the product in Europe by year's end.