MONTREAL, CANADA--(Marketwire - Dec. 17, 2012) - Paladin Labs Inc. (PLB.TO) a leading Canadian specialty pharmaceutical company, today announced that Health Canada has approved Silenor® (doxepin hydrochloride) for the treatment and symptomatic relief of insomnia characterized by frequent nocturnal awakening and/or early morning awakenings. Silenor is a non-controlled medication which does not produce tolerance or physical dependence.1 Paladin expects to launch Silenor in the middle of 2013.
There are approximately 3.3 million Canadians suffering from insomnia, with 29% having taken sleep medication at least once in the previous 12 months.2 The Canadian market for prescriptions sleep medications exceeded $89 million over the 12 months ending October 2012.3 In Canada, the prescription sleep medication market largely consists of zopiclone, a non-benzodiazepine hypnotic, first approved for sale in Canada in 1990.
"We are pleased that Health Canada has granted regulatory approval for Silenor," said Mark Beaudet, interim President and Chief Executive Officer of Paladin Labs Inc. "Canadians who suffer from insomnia have a new effective treatment option that is not associated with a risk of abuse or physical dependence."
Paladin received rights to commercialize Silenor in Canada, South America and Africa from Somaxon Pharmaceuticals, Inc. (SOMX) in June 2011.
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 select international markets. With this strategy, a focused Canadian national sales team and proven marketing expertise, Paladin has evolved into one of Canada's leading specialty pharmaceutical companies. For more information, please visit the Company's web site at www.paladinlabs.com.
1 Silenor Product Monograph, December 2012
2 2002, the Canadian Community Health Survey; Statistics Canada, Catalogue 82-003; Health Reports, Vol. 17, No. 1, November 2005 pp 10-11
3 IMS Health - moving annual total for the 12 months ended October 31, 2012
Forward Looking Statements
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 subsidiaries, 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.