Paladin Labs Inc., a Canadian specialty pharmaceutical company, today announced that they have entered into a licensing and distribution agreement under which Paladin has been granted exclusive Canadian rights from an affiliate of Elan Corporation, plc to market and sell, upon regulatory approval, Elan's controlled release hydrocodone product for the treatment of moderate to severe pain.
According to IMS Canada, the Canadian oral extended release opioid market in 2010 exceeded 4 million prescriptions representing sales of more than $385 million. At present, there is no single-entity, controlled-release formulation of hydrocodone in Canada presenting a significant unmet medical need in the treatment of moderate to severe pain. The product, which incorporates Elan's proprietary SODAS technology, offers a unique, controlled-release profile which utilizes both immediate release and extended release properties designed to enable twice daily dosing. This product is expected to allow for less frequent dosing with a customized controlled-release profile and the ability to titrate to higher hydrocodone doses. In the treatment of chronic pain, the product is anticipated to avoid some of the serious side effects associated with the use of combination opioids that contain acetaminophen, or non-steroidal anti-inflammatory drugs (NSAIDs). The product is currently in two pivotal phase III trials in the US and is expected to be submitted for Health Canada approval in the second half of 2012.
"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."
Under the terms of the Agreement, Elan will receive from Paladin undisclosed upfront and milestone payments for the product. Additionally, Elan will receive manufacturing fees and royalty payments based on sales of the product upon commercialization.