Health Canada accepts Paladin's Silenor NDS for review

Feb 23 2012

Paladin Labs Inc. (TSX:PLB) and Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) today announced that Paladin has filed a New Drug Submission (NDS) that has been accepted for review by Health Canada for Silenor^® (doxepin) for the treatment and symptomatic relief of insomnia.

"We are pleased that Health Canada has accepted to review our submission for Canadian regulatory approval for Silenor^®," said Mark Beaudet, interim President and Chief Executive Officer of Paladin Labs Inc. "We believe that Silenor^® can fill a significant unmet need in the Canadian insomnia market. To date, the Canadian prescription sleep aid market has consisted mainly of zopiclone, an older medication that, despite its limitations, has driven the market to exceed $87 million in 2011, an increase of 10% vs. 2010."

If approved, Silenor^® could be the first and only prescription product approved for the treatment of insomnia in Canada that is not a controlled substance.

Paladin received rights to commercialize Silenor^® in Canada, South America and Africa from Somaxon in June 2011. Under the collaboration agreements, there is no payment due to Somaxon from Paladin as a result of the NDS filing. Once Silenor^® is commercialized in the licensed territories, Somaxon will be eligible to receive sales-based milestone payments of up to US$128.5 million as well as a tiered double-digit percentage of net sales.