Healthcare Industry News: Silenor
News Release - August 18, 2008
Somaxon Pharmaceuticals Announces the Appointment of Senior Commercial Leadership
SAN DIEGO--(HSMN NewsFeed)--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 the appointments of Daniel Schneider to the newly-created position of Vice President of Sales and Joseph Merkert to the newly-created position of Vice President of Sales Operations and Managed Care.“These hirings represent our commitment to attracting top commercial talent as we plan for the potential commercialization of Silenor™,” said Richard Pascoe, President and CEO of Somaxon. “I look forward to working with Dan and Joe as we continue our progress towards building a leading specialty pharmaceutical company.”
Mr. Schneider brings to Somaxon more than 16 years of experience in pharmaceutical sales and sales management, the last 10 of which were spent at Sepracor, Inc. Most recently, he was that company’s Area Vice President of Sales. In that role, he led a sales force of over 500 representatives and managers. Mr. Schneider was also integral to the development of the infrastructure of Sepracor’s sales organization, including sales training. Earlier, he was a Regional Account Executive at Solvay Pharmaceuticals, Inc.
Mr. Merkert joins Somaxon from Verus Pharmaceuticals, where he was Vice President of Commercial Operations. At Verus, he was responsible for managing the development of all of the company’s commercial operations as it prepared for and implemented the launch of its first product. Prior to joining Verus in 2004, Mr. Merkert held various positions of increasing responsibility in pharmaceutical sales, marketing and managed care over 14 years, including Director of National Account Operations at Amylin Pharmaceuticals.
“We are pleased to have Dan and Joe join Somaxon in these important roles,” commented Jeff Raser, Somaxon’s Senior Vice President of Sales and Marketing. “Dan brings valuable sales leadership experience in the competitive insomnia market segment, and Joe has significant experience in building and implementing commercial operations. Their skills in leading internal sales teams and working with third party collaborators will be essential as we implement our Silenor™ commercial strategy.”
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™ (doxepin HCl) for the treatment of insomnia. The FDA has notified Somaxon that it accepted the NDA for Silenor™ for review as of March 31, 2008. Pursuant to PDUFA guidelines, 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.
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 potential approval of the NDA for Silenor™ and the commercialization of Silenor™ either alone or together with third parties 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 ability of our senior management team, some of whom have limited experience working together as a group, to manage our business effectively; the potential for Silenor™ to receive regulatory approval for one or more indications on a timely basis or at all; the potential for the FDA to impose non-clinical, clinical or other requirements to be completed before or after regulatory approval of Silenor™; Somaxon’s ability to demonstrate to the satisfaction of the FDA that potential NDA approval of Silenor™ is appropriate prior to the completion of standard, long-term carcinogenicity studies, given the context of completed trials and pending studies; the timing and results of non-clinical studies for Silenor™, and the FDA’s agreement with Somaxon’s interpretation of such results; the potential to enter into and the terms of any strategic transaction relating to Silenor™; the scope, validity and duration of patent protection and other intellectual property rights for Silenor™; whether any approved label for Silenor™ is sufficiently consistent with such patent protection to provide exclusivity for Silenor™; Somaxon’s ability to operate its business without infringing the intellectual property rights of others; unexpected findings relating to Silenor™ 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™; the market potential for insomnia treatments, and Somaxon’s ability to compete within that market; Somaxon’s ability to raise sufficient capital and meet its obligations to parties with whom it contracts relating to financing activity, and the impact of any such financing activity on the level of Somaxon’s stock price; 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.
Source: Somaxon Pharmaceuticals
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