Somaxon Pharmaceuticals Announces Settlement of Silenor Patent Litigation With Actavis
06 2월 2013 - 6:30AM
Somaxon Pharmaceuticals, Inc. (Nasdaq:SOMX), a specialty
pharmaceutical company, today announced that it has entered into a
settlement agreement with Actavis Elizabeth LLC and Actavis Inc. to
resolve pending patent litigation involving Silenor® 3 mg and 6 mg
tablets.
The settlement agreement grants Actavis the right to begin
selling a generic version of Silenor on January 1, 2020, or earlier
under certain circumstances. The settlement agreement will become
effective upon the entry by the U.S. District Court for the
District of Delaware of an order dismissing the litigation with
respect to Actavis.
"We are pleased to enter into this settlement agreement, which
resolves the last of our four patent litigation lawsuits relating
to Silenor," said Richard W. Pascoe, Somaxon's President and Chief
Executive Officer. "With exclusivity for Silenor for the next seven
years, we believe that commercial resources can confidently be
devoted to Silenor going forward to grow sales of the product."
About Somaxon Pharmaceuticals, Inc.
Headquartered in San Diego, CA, Somaxon Pharmaceuticals, Inc. is
a specialty pharmaceutical company focused on the in-licensing,
development and commercialization of proprietary branded products
and product candidates to treat important medical conditions where
there is an unmet medical need and/or high level of patient
dissatisfaction, currently in the central nervous system
therapeutic area. Somaxon's product Silenor, available by
prescription in the United States, is indicated for the treatment
of insomnia characterized by difficulty with sleep maintenance.
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
Safe Harbor Statement
Somaxon cautions readers that statements included in this press
release that are not a description of historical facts are
forward-looking statements. For example, statements regarding the
settlement of litigation with Actavis and the entry by the U.S.
District Court for the District of Delaware of an order dismissing
the litigation with respect to Actavis, the potential to grow sales
of Silenor and Somaxon's other activities and plans 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, Somaxon's ability to successfully market and
sell Silenor; the market potential for insomnia treatments, and
Somaxon's ability to compete within that market; risks related to
the settlement agreements with Actavis, including any legal or
regulatory challenges to the settlement agreement by the U.S.
Department of Justice and/or the U.S. Federal Trade Commission, and
the outcome of any such challenges; 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 enforce
its intellectual property rights and defend its patents; the
potential to enter into an agreement with any third party relating
to over-the-counter rights for Silenor; Somaxon's ability, together
with any partner, to receive FDA approval for an over-the-counter
version of Silenor; changes in healthcare reform measures and
reimbursement policies; 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; Somaxon's
reliance on its licensees, Paladin Labs and CJ CheilJedang, for
critical aspects of the commercial sales process for Silenor
outside of the United States; the performance of Paladin and CJ
CheilJedang and their adherence to the terms of their contracts
with Somaxon; inadequate therapeutic efficacy or unexpected adverse
side effects relating to Silenor that could adversely impact
commercial success, or 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 as well
as in its periodic filings with the SEC.
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: Tran Nguyen / CFO
Somaxon Pharmaceuticals, Inc.
(858) 876-6500
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