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Somaxon Pharmaceuticals Receives Notice of Allowance for Patent Application Relating to Pharmacokinetics of Silenor

^{Published on 2011-02-22 13:11:20 - Market Wire}
 

SAN DIEGO--([ BUSINESS WIRE ])--Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX), a specialty pharmaceutical company, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for claims in U.S. patent application no. 11/781,165. This patent application generally relates to dosing Silenor at least three hours after a meal to promote faster onset of action and reduce the potential for next-day residual sedation. A Notice of Allowance is the official notification that the USPTO finds the claimed subject matter allowable and intends to issue the patent pending payment of the issue fee. Given this action, Somaxon expects the patent to issue within the next few months. Once issued, this patent will expire no earlier than July 2027. Somaxon will list the patent in the Orange Book once it is issued.

"This food effect patent will further bolster our Silenor patent estate, and we expect that it will provide us with a significant opportunity to drive Silenor growth well into the next decade"

aThis food effect patent will further bolster our Silenor patent estate, and we expect that it will provide us with a significant opportunity to drive Silenor growth well into the next decade,a said Richard W. Pascoe, Somaxona™s President and Chief Executive Officer. aThe pharmacokinetic changes that result from dosing Silenor within three hours after a meal have important implications relating to both the efficacy and safety of the product that are described in the Silenor prescribing information.a

About Silenor^®

Silenor is a low-dose (3 mg, 6 mg) oral tablet formulation of doxepin, and is the first and only non-scheduled prescription sleep medication approved to treat insomnia characterized by difficulty with sleep maintenance. Sleep maintenance is defined as waking frequently during the night and/or waking too early and being unable to return to sleep.

Important Safety Information

A doctor should be consulted if insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing the sleep problem.

Patients should be sure that they are able to devote 7 to 8 hours to sleep before being active again. Silenor should be taken within 30 minutes of bedtime. Patients should not take Silenor with alcohol or with other medicines that can cause drowsiness. Silenor should not be taken with or within two weeks after taking a monoamine oxidase inhibitor (MAOI). Patients should not take Silenor if they have untreated narrow angle glaucoma, if they have severe urinary retention, if they have severe sleep apnea or if they are allergic to any of the ingredients in Silenor. Until patients know how they will react to Silenor, they should not drive or operate machinery at night after taking Silenor, and they should be careful in performing such activities during the day following taking Silenor. Before taking Silenor, patients should tell their doctors if they have a history of depression, mental illness or suicidal thoughts. Patients should call their doctors right away if after taking Silenor they walk, drive, eat or engage in other activities while asleep. Drowsiness was the most common adverse event observed in clinical trials.

For more information, please see the complete Prescribing Information, including the Medication Guide, at [ www.silenor.com ] or [ www.somaxon.com ].

To be added to Somaxon Pharmaceuticalsa™ email list, please visit [ http://bit.ly/Somaxon-email-list ].

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 pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area. Somaxona™s product Silenor^® (doxepin), now 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 companya™s web site at [ www.somaxon.com ].

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 issuance of a patent resulting from the Notice of Allowance for U.S. patent application no. 11/781,165, the listing of that patent in the Orange Book and the potential for commercial sales into the future 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 Somaxona™s business, including, without limitation, 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; Somaxona™s ability to successfully commercialize Silenor; Somaxona™s reliance on its co-promotion partner, Procter & Gamble, and its contract sales force provider, Publicis, for critical aspects of the commercial sales process for Silenor; the performance of Procter & Gamble and Publicis and their adherence to the terms of their contracts with Somaxon; the ability of Somaxona™s sales management personnel to effectively manage the sales representatives employed by Publicis; the ability of Somaxon to ensure adequate and continued supply of Silenor to successfully meet anticipated market demand; Somaxona™s ability to successfully enforce its intellectual property rights and defend its patents, including any developments relating to the recent submission of abbreviated new drug applications for generic versions of Silenor 3 mg and 6 mg and related patent litigation; the possible introduction of generic competition for Silenor; Somaxona™s ability to raise sufficient capital to fund its operations, and the impact of any such financing activity on the level of its stock price; the impact of any inability to raise sufficient capital to fund ongoing operations, including any patent infringement litigation; Somaxona™s ability to operate its business without infringing the intellectual property rights of others; the market potential for insomnia treatments, and Somaxona™s ability to compete within that market; inadequate therapeutic efficacy or unexpected adverse side effects relating to Silenor that could delay or prevent commercialization, 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 FDAa™s agreement with Somaxona™s interpretation of such results; and other risks detailed in Somaxona™s prior press releases as well as in its 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.