http://www.paladin-labs.com () —
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.
About SODAS@ Technology
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
(http://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
(http://www.sedar.com) .