Somaxon Announces That Paladin Labs Has Received Approval of New Drug Submission for Silenor (R) in Canada

Somaxon Announces That Paladin Labs Has Received Approval of New Drug
Submission for Silenor (R) in Canada

SAN DIEGO, Dec. 17, 2012 (GLOBE NEWSWIRE) -- Somaxon Pharmaceuticals, Inc.
(Nasdaq:SOMX) today announced that its licensee Paladin Labs Inc. (TSX:PLB)
has received approval from Health Canada of Paladin's New Drug Submission
(NDS) for Silenor^® (doxepin) for the treatment and symptomatic relief of
insomnia characterized by frequent nocturnal awakening and/or early morning
awakenings.

"We are pleased that Health Canada has approved Silenor^® 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."

About Silenor^®

Silenor^® 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^® 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^® 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.

CONTACT: Somaxon Pharmaceuticals, Inc.
         Tran Nguyen
         Chief Financial Officer
         (858) 876-6500

Somaxon Pharmaceuticals, Inc. Logo
 
Press spacebar to pause and continue. Press esc to stop.