MONTREAL, QUEBEC--(Marketwire - May 12, 2011) - Paladin Labs Inc. (TSX:PLB), a leading 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 ("Elan") 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.
SODAS (Spheroidal Oral Drug Absorption System) is Elan Drug Technologies' multiparticulate drug delivery system. SODAS Technology continues to be an accepted and approved system by regulatory authorities with approvals for the SODAS based system occurring in the US for Avinza®, Ritalin LA® and Focalin XR®. A number of other compounds are in late stage development utilizing Elan's SODAS® technology. The SODAS® technology is part of a suite of capabilities available through Elan Drug Technologies.
SODAS is a registered trademark of Elan Pharma International Ltd.
AVINZA is a registered trademark of King Pharmaceuticals Research and Development, Inc.
FOCALIN XR and RITALIN LA are registered trademarks of Novartis AG
Tridural, Metadol and Abstral are Canadian registered trademarks of Labopharm Inc., Pharmascience Inc. and Strakan International Ltd., respectively.
About Paladin Labs Inc.
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and world markets. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into one of Canada's leading specialty pharmaceutical companies. Paladin's shares trade on the Toronto Stock Exchange under the symbol PLB. For more information about Paladin, please visit the Company's web site at www.paladinlabs.com.
This press release may contain forward-looking statements and predictions. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. The Company considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions that these assumptions regarding the future events, many of which are beyond the control of the Company and its subsidiary, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the annual report as well as in the Company's Annual Information Form for the year ended December 31, 2010. The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events and except as required by law. For additional information on risks and uncertainties relating to these forward-looking statements, investors should consult the Company's ongoing quarterly fillings, annual report and Annual Information Form and other fillings found on SEDAR at www.sedar.com.