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.