Health Canada Approves Paladin Labs Inc. Silenor New Drug Submission
Published: Dec 18, 2012
"We are pleased that Health Canada has approved Silenor(R) and commend our colleagues at Paladin for their efforts to bring this important insomnia treatment to the Canadian market," said Richard W. Pascoe, President and Chief Executive Officer of Somaxon. "We look forward to Paladin's launch of Silenor, which is expected to occur in the middle of 2013."
Silenor(R) is a low-dose (3 mg and 6 mg) oral tablet formulation of doxepin. In clinical trials, Silenor demonstrated maintenance of sleep, including into the seventh and eighth hours of the night, with no meaningful evidence of next day residual effects and an overall adverse events profile that was comparable to placebo. Paladin received rights to commercialize Silenor(R) in Canada, South America and Africa from Somaxon in June 2011.
About Somaxon Pharmaceuticals, Inc.
Headquartered in San Diego, CA, Somaxon Pharmaceuticals, Inc. is a specialty pharmaceutical company that sells Silenor(R) in the United States. For more information, please visit the company's web site at www.somaxon.com.
The Somaxon Pharmaceuticals logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13679
Forward Looking Statements: Somaxon cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. For example, statements regarding the commercial launch of Silenor in Canada and the potential commercial launch of Silenor in other countries outside the United States are forward looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Somaxon that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Somaxon's business, including, without limitation, the market potential for insomnia treatments, and Somaxon's and Paladin Labs' ability to compete within that market; Somaxon's reliance on its collaboration partner, Paladin Labs, and its adherence to the terms of its contract; Somaxon's ability to successfully enforce its intellectual property rights and defend its patents, including any developments relating to the submission of abbreviated new drug applications for generic versions of Silenor 3 mg and 6 mg tablets and related patent litigation; the possible introduction of generic competition of Silenor; the scope, validity and duration of patent protection and other intellectual property rights for Silenor; whether the approved label for Silenor is sufficiently consistent with such patent protection to provide exclusivity for Silenor; Somaxon's ability to successfully commercialize Silenor in the United States; the ability of Somaxon to ensure adequate and continued supply of Silenor to successfully meet anticipated market demand; Somaxon's ability to operate its business without infringing the intellectual property rights of others; inadequate therapeutic efficacy or unexpected adverse side effects relating to Silenor that could result in recalls or product liability claims; other difficulties or delays in development, testing, manufacturing and marketing of Silenor; the timing and results of post-approval regulatory requirements for Silenor, and the FDA's agreement with Somaxon's interpretation of such results; and other risks detailed in Somaxon's prior press releases and periodic filings with the Securities and Exchange Commission.
Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Somaxon undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934.
Somaxon Pharmaceuticals, Inc.
Chief Financial Officer