Somaxon Pharmaceuticals Announces Completion of 26-Week Transgenic Mouse Carcinogenicity Study of Silenor
SAN DIEGO--(BUSINESS WIRE)--Jan 9, 2008 - Somaxon Pharmaceuticals, Inc. (Nasdaq:SOMX), a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology, today announced that it has completed a 26-week transgenic mouse carcinogenicity study of doxepin, the active pharmaceutical ingredient in its product candidate SILENOR(TM). Based on the results of this study and a review of such results with its consultant toxicologists, Somaxon intends to proceed with the submission of a New Drug Application for SILENOR(TM), which is now estimated to occur by mid-February 2008."We are pleased to be in a position to finalize our NDA submission ahead of our projected schedule," said David F. Hale, Somaxon's Executive Chairman and interim Chief Executive Officer. "Given the strong clinical profile of SILENOR(TM), we believe that SILENOR(TM) has the potential to provide physicians and patients with a unique and clinically differentiated alternative to currently available treatments for insomnia, if the NDA is approved by the FDA. We anticipate that SILENOR(TM) could be the first new product approved for the treatment of insomnia since 2006. We are continuing discussions with potential strategic collaborators who can assist us in maximizing the overall potential of SILENOR(TM)."
Background
As previously disclosed, based on a request from the FDA in May 2006, Somaxon initiated a preclinical program for SILENOR(TM) consisting of standard genotoxicity, reproductive toxicology and carcinogenicity studies. At that time, the FDA indicated that the data from the genotoxicity studies and reproductive toxicology studies should be included in the NDA for SILENOR(TM). The FDA also indicated that depending on the outcome of the genotoxicity studies, it may be flexible as to the timing of the conduct of the carcinogenicity studies, including the potential that the data from those studies may be submitted as a post-NDA approval commitment.
Somaxon completed the genotoxicity studies, and no signal indicative of genotoxicity was found in any of the assays. The company submitted the results to the FDA, and in February 2007 the FDA agreed with the company's assessment that SILENOR(TM) does not appear to have genotoxic potential. The FDA indicated that, unless other preclinical data raise a concern, a complete assessment of the carcinogenic potential of SILENOR(TM) may not be needed prior to NDA approval. The FDA also indicated that it may accept the results of a shorter-term carcinogenicity study for approval of the NDA and allow the standard two-year carcinogenicity study to be completed as a post-NDA approval commitment.
In May 2007, Somaxon received correspondence from the FDA which stated that the results of its 26-week transgenic mouse carcinogenicity study of SILENOR(TM) should be included as part of the initial NDA submission for SILENOR(TM). As indicated above, this study was completed in January 2008, and the results will be included in the company's planned NDA submission. The planned NDA submission will also include the results of the company's reproductive toxicology studies, which were completed in June 2007.
In August 2007, the company initiated a two-year rat carcinogenicity study, and it plans to submit the results of that study as a post-approval commitment.
About Somaxon Pharmaceuticals, Inc.
Headquartered in San Diego, CA, Somaxon Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology. Somaxon has completed four successful Phase 3 clinical trials for its lead product candidate, SILENOR(TM) (doxepin HCl) for the treatment of insomnia.
For more information, please visit the company's web site at www.somaxon.com.
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 interpretation of the results of Somaxon's non-clinical studies and the FDA's agreement therewith, Somaxon's ability to submit an NDA for SILENOR(TM) with the FDA on the timeframes described above and the FDA's agreement that Somaxon may complete and submit the results of its two-year carcinogenicity study of SILENOR(TM) as a post-approval commitment 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 results of preclinical studies for SILENOR(TM), and the FDA's agreement with Somaxon's interpretation of such results; the timing of receipt of preclinical study results and any NDA submission, and the acceptance for filing of such submission by the FDA; the potential for the FDA to require preclinical or clinical requirements to support an NDA filing for SILENOR(TM), or the imposition of additional requirements to be completed before or after regulatory approval; Somaxon's ability to demonstrate to the satisfaction of the FDA that potential NDA approval of SILENOR(TM) is appropriate without standard, long-term carcinogenicity studies, given the context of completed trials and pending studies; the potential to enter into and the terms of any strategic transaction relating to SILENOR(TM); the potential for SILENOR(TM) to receive regulatory approval for one or more indications and with a label that is consistent with Somaxon's patent protection on a timely basis or at all; the scope, validity and duration of patent protection and other intellectual property rights for SILENOR(TM); Somaxon's ability to have such patent protection provide exclusivity for SILENOR(TM); Somaxon's ability to operate its business without infringing the intellectual property rights of others; unexpected findings relating to SILENOR(TM) that could delay or prevent regulatory approval or commercialization, or that could result in recalls or product liability claims; other difficulties or delays in development, testing, manufacturing and marketing of and obtaining regulatory approval for SILENOR(TM); the market potential for insomnia and other target markets, and Somaxon's ability to compete; Somaxon's ability to raise sufficient capital; and other risks detailed in Somaxon's prior press releases as well as in its periodic filings with the Securities and Exchange Commission.
You 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 news 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.
Meg McGilley, Chief Financial Officer
858-480-0402
or
PondelWilkinson, Inc.
Rob Whetstone, 310-279-5963
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