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Paladin Labs Inc
Symbol PLB
Shares Issued 20,270,836
Close 2012-02-21 C$ 42.04
Market Cap C$ 852,185,945
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Paladin Labs files new drug submission for Silenor

2012-02-22 17:17 ET - News Release

Mr. Tran Nguyen reports

PALADIN AND SOMAXON ANNOUNCE FILING OF NEW DRUG SUBMISSION FOR SILENOR(R)

Paladin Labs Inc. 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. "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 per cent versus 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 $128.5-million (U.S.) as well as a tiered double-digit percentage of net sales.

About Somaxon Pharmaceuticals, Inc.

Headquartered in San Diego, Calif., Somaxon Pharmaceuticals, Inc. is a specialty pharmaceutical company that sells Silenor in the United States. For more information, please visit the company's website.

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