Date of Report (Date of earliest event reported): December 23, 2010
SOMAXON PHARMACEUTICALS, INC.
Registrants telephone number, including area code: (858) 876-6500
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Item 8.01 Other Events.
On December 23, 2010, Somaxon Pharmaceuticals, Inc. (Somaxon) received a notice from Par Pharmaceuticals, Inc. (Par) that it has filed with the U.S. Food and Drug Administration (the FDA) an Abbreviated New Drug Application (ANDA) for a generic version of Silenor® (doxepin) 3 mg and 6 mg tablets. This notice included a paragraph IV certification with respect to seven of the eight patents listed in the FDAs Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, for Silenor. A paragraph IV certification is a certification by a generic applicant that in the opinion of that applicant, the patent(s) listed in the Orange Book for a branded product are invalid, unenforceable, and/or will not be infringed by the manufacture, use or sale of the generic product.
Somaxon is currently reviewing the details of the notice. Under the Hatch-Waxman Act, if Somaxon initiates a patent infringement suit asserting infringement of any of the patents identified in a paragraph IV notice within 45 days after its receipt of such notice, the FDA will not approve the ANDA until the earlier of 30 months or a decision that all of such patents are not infringed and/or invalid, unless either party to the action failed to cooperate reasonably to expedite the infringement action.
Somaxon intends to vigorously enforce its intellectual property rights relating to Silenor, but cannot predict the outcome of this matter or guarantee the outcome of any litigation. Silenor is protected by eight patents covering approved methods of use of the product and its formulation, all of which are listed in the Orange Book.
For a discussion of risks related to ANDA filings and a description of the circumstances relating to ANDA filings for Silenor of which Somaxon has been notified, see the discussion of Intellectual Property under the Business section of Somaxons Annual Report on Form 10-K for the year ended December 31, 2009 filed by Somaxon with the Securities and Exchange Commission (the SEC) on March 18, 2010, the Risk Factors section of Somaxons Quarterly Report on Form 10-Q for the period ended September 30, 2010 filed by Somaxon with the SEC on November 10, 2010, including the risk factor under the heading Restrictions on or challenges to our patent rights relating to our products and limitations on or challenges to our other intellectual property rights may limit our ability to prevent third parties from competing against us, and the Current Reports on Form 8-K filed by Somaxon with the SEC on November 3, 2010 and December 20, 2010, as well as any updates to such discussion and descriptions contained in Somaxons subsequent public disclosure documents.
Somaxon cautions readers that statements included in this report that are not a description of historical facts are forward-looking statements. For example, statements regarding Somaxons intention to vigorously enforce its patent rights 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 report due to the risks and uncertainties inherent in Somaxons business, including, without limitation, Somaxons ability to successfully enforce its intellectual property rights and defend its patents; the possible introduction of generic competition of Silenor; Somaxons ability to successfully commercialize Silenor; Somaxons dependence on sales of Silenor; Somaxons 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 Somaxons 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; Somaxons ability to raise sufficient capital to fund its operations, including any patent infringement litigation, 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; Somaxons ability to operate its business without infringing the intellectual property rights of others; the market potential for insomnia treatments, and Somaxons 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 FDAs agreement with Somaxons interpretation of such results; and other risks detailed in Somaxons 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 report 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.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.