Somaxon Pharmaceuticals, Inc. (NASD: 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, recently announced that the company’s president and chief executive officer, Richard Pascoe, presented earlier this week at the Natixis Bleichroeder second annual Hidden Gems Conference in New York, NY.
At the conference, Mr. Pascoe stated that Somaxon has completed four successful Phase 3 clinical trials for its lead product candidate, Silenor® (doxepin HCl) for the treatment of insomnia. In each of these clinical trials, Silenor® demonstrated statistically significant and clinically meaningful results in the designated primary endpoint and in several other important secondary endpoints. Somaxon expects that the FDA will complete its review and provide an action letter to the company with respect to the NDA by December 1, 2008.
Regarding the results of the Silenor® clinical trial, Mr. Pascoe stated, “There is a significant opportunity for a new drug like this to enter the market and gain substantial market share. Partnering is important and could happen at any time, but we are focused on getting this drug approved, building a commercial platform and launching the drug early next year. We will take the lead in terms of marketing this product.” Mr. Pasco added, “We have approximately $32 million cash available to us, and we continue to maintain that we will have a cash runway to us to take us through the first quarter.”
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