Knobias Clip Report (10-13-2008) SOMX
Submitted By Knobias ClipReport
SOMX: CEO Discusses Commercialization Strategy for Silenor(R) to Treat Insomnia
By Fain Hughes, fhughes@knobias.com
The President and CEO of Somaxon Pharmaceuticals, Incorporated (SOMX), Richard Pascoe, presented today at the Natixis Bleichroeder 2nd Annual Hidden Gems Conference in New York, NY.
Somaxon has completed four successful Phase 3 clinical trials for its lead product candidate, Silenor(R) (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. These endpoints included measures of both sleep maintenance and sleep onset. The FDA notified Somaxon that it accepted the New Drug Application (NDA) for Silenor for review as of March 31, 2008. 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.
Mr. Pasco explained, “There is a highly dissatisfied market among the 70 million adults who suffer from insomnia. A large majority of patients do not seek prescription treatment because the drugs on the market either don’t work or have serious side effects such as addiction profiles. We will go to market with a differentiated drug that is not a GABA or melatonin drug. It will also not be a DEA Scedule drug, which many physicians are reluctant to prescribe. There is a significant opportunity for a new drug like this to enter the market and gain substantial market share. We believe out product is superior across the board.”
He added, “Our focus now is the commercialization of this drug. We are having active discussions with potential partners. We intend to under any circumstances build our own commercial platform because in order for a company to build long term value, it has to participate in the commercialization of a product. 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 noted, “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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