Somaxon Announces That Paladin Labs Has Received Approval of New Drug Submission for Silenor (R) in Canada
17 Décembre 2012 - 10:35PM
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 (NASDAQ:SOMX)
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