Paladin Labs has entered into a licensing and distribution agreement with Elan Corp. under which Paladin has exclusive Canadian rights to market and sell (upon regulatory approval) Elan’s controlled release hydrocodone product for the treatment of moderate to severe pain. Elan will receive an undisclosed upfront payment for the product, milestones and manufacturing fees and royalties based on sales.

Currently, there is no single-entity, controlled-release formulation of hydrocodone in Canada. The product, which incorporates Elan’s proprietary SODAS technology, offers a controlled-release profile, which uses both immediate release and extended release properties designed to enable twice daily dosing. The product is currently in two Phase III trials in the U.S. and is expected to be submitted for Health Canada approval in 1H12.

“We are excited to add a further treatment option for Canadian pain sufferers and their physicians,” said Jonathan Ross Goodman, president and chief executive officer of Paladin Labs, Inc. “This product, if approved, will complement our dynamic and growing promoted pain portfolio, which already includes Tridural, Metadol, and Abstral and will provide us an additional pillar upon which to strengthen our pain franchise.”