Somaxon Pharmaceuticals Announces FDA Feedback On Silenor OTC Regulatory Pathway And Changes To Commercial Team

Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX), a specialty pharmaceutical company, today announced that it recently had a meeting with the U.S. Food & Drug Administration (FDA) relating to the over-the-counter (OTC) development program for Silenor®. In the meeting, which Somaxon attended jointly with its Silenor partner Procter & Gamble, the FDA provided clinical and regulatory guidance that the company believes provides a clear path forward toward an OTC version of Silenor.

Somaxon believes that the FDA’s guidance provides an opportunity to develop an OTC label that is tailored to Silenor’s clinical profile and differentiated from other OTC sleep products. Somaxon believes that Silenor’s characteristics, including its lack of addiction potential and its clinical efficacy and safety profile, make it an ideal candidate to be the first prescription insomnia product to be converted to an OTC product.

Somaxon also announced changes to its commercial team that promotes Silenor for the treatment of insomnia characterized by difficulty with sleep maintenance. In particular, Somaxon announced that:
  • it has amended the Co-Promotion Agreement with Procter & Gamble so that Procter & Gamble’s exclusive negotiation period relating to OTC rights to Silenor is extended from 60 to 120 days, and to discontinue the co-promotion services under the agreement as of December 31, 2011.
  • it has appointed Michael Allen as Senior Vice President, Sales and Marketing. Mr. Allen replaces Jeff Raser, who has resigned from the company to pursue other interests.
  • it has provided notice to Publicis Touchpoint Solutions, Inc. that it intends to hire the Publicis sales force promoting Silenor as Somaxon employees during the fourth quarter of 2011. In connection with the conversion of the sales force, Somaxon will terminate the Professional Detailing Services Agreement with Publicis effective as of December 31, 2011.

“Our first year of marketing Silenor has provided us with a host of learnings relating to the market and the most efficient use of our resources to promote Silenor for the treatment of insomnia,” said Richard W. Pascoe, Somaxon’s President and Chief Executive Officer. “We believe that the changes we are announcing today will enable us to focus our sales and marketing resources in the most efficient and effective way as we move forward through the fourth quarter and into 2012.”

“The changes to the Procter & Gamble agreement represent the natural evolution of our relationship at this stage in Silenor’s commercial growth, allowing us to reallocate resources from sales support toward Silenor consumer awareness initiatives, while continuing to explore the potential for a Silenor OTC life cycle management opportunity with a highly differentiated label,” continued Pascoe.

“We are excited to add Mike Allen to our team given his extensive track record of success in leading sales, marketing and managed care teams to drive product growth. Hiring the dedicated sales team as Somaxon employees will allow us to more closely align the incentives of the sales force with our commercial and corporate objectives, reduce the per-representative cost of our sales force, and enhance sales force effectiveness.”

“Lastly, we wish to thank Jeff Raser for his contributions to the company over the years, and we wish him well in his future endeavors.”

Mr. Allen brings to Somaxon over 25 years of commercial experience in the pharmaceutical industry, including 15 years in general management and senior sales and marketing positions. Mr. Allen was most recently Senior Vice President, Commercial Operations at ProteoGenix, Inc., and he previously held senior commercial management positions at Tercica, Inc., Prometheus Laboratories Inc. and Ther-Rx Corp. In each of these positions Mr. Allen played a leading role in creating commercial infrastructures and launching products. Mr. Allen also served in a number of senior commercial roles at Serono Inc., including positions as General Manager, Serono Canada, and Executive Vice President, North American Reproductive Endocrinology Business Unit. During his tenure at Serono, Mr. Allen led a number of successful flagship product launches and had direct responsibility for all aspects of a commercial operation generating more than $250M in annual revenue.

There is no termination fee or other material obligation that will result from the termination of the Publicis agreement. As a result of the discontinuation of co-promotion services under the Procter & Gamble agreement, Procter & Gamble will be entitled to a low single-digit royalty on net sales of Silenor for the 2012 fiscal year.

Conference Call Information and Forward-Looking Statements

On Tuesday, October 4, 2011, Somaxon will conduct a conference call with interested parties beginning at 8:30 a.m. ET (5:30 a.m. PT) to discuss the FDA’s OTC feedback, the changes to the Silenor commercial team and related matters. The conference call will be available to interested parties through a live audio Internet broadcast at http://investors.somaxon.com/eventdetail.cfm. The call will also be archived and accessible at this site for approximately two weeks. Alternatively, callers may participate in the conference call by dialing (480) 629-9835, conference call ID 4477168. A telephonic replay will be available for approximately two weeks following the conclusion of the call by dialing (303) 590-3030, and entering passcode 4477168.

Discussion during the conference call may include forward-looking statements regarding such topics as, but not limited to, the company’s commercial plans and activities relating to Silenor, prescription trends, the company’s financial status and performance, the potential to develop an OTC version of Silenor, and any comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

About Somaxon Pharmaceuticals, Inc.

Headquartered in San Diego, CA, Somaxon Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded products and late-stage product candidates to treat important medical conditions where there is an unmet medical need and/or high-level of patient dissatisfaction, currently in the central nervous system therapeutic area. Somaxon’s product Silenor, now available by prescription in the United States, is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.

For more information, please visit the company’s web site at www.somaxon.com.

Safe Harbor Statement

Somaxon cautions readers that statements included in this press release and the conference call that are not a description of historical facts are forward-looking statements. For example, statements regarding the hiring by Somaxon of Mr. Allen and the sales force, the anticipated reduction in per-representative cost and enhancement of effectiveness of such sales force, the potential to enter into a separate agreement with Procter & Gamble relating to OTC rights for Silenor, the potential to successfully develop an OTC Silenor product and Somaxon’s other commercial activities and plans 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 and the conference call due to the risks and uncertainties inherent in Somaxon’s business, including, without limitation, Somaxon’s ability to successfully commercialize Silenor; the market potential for insomnia treatments, and Somaxon’s ability to compete within that market; the potential to enter into an agreement with Procter & Gamble relating to OTC rights for Silenor; Somaxon’s ability, together with any partner, to receive FDA approval for an OTC version of Silenor; Somaxon’s ability to successfully hire a sales force, including the transition of Publicis representatives to Somaxon employees; the scope, validity and duration of patent protection and other intellectual property rights for Silenor; whether the approved label for Silenor is sufficiently consistent with such patent protection to provide exclusivity for Silenor; Somaxon’s ability to successfully enforce its intellectual property rights and defend its patents, including any developments relating to the recent submission of abbreviated new drug applications for generic versions of Silenor 3 mg and 6 mg and related patent litigation; the possible introduction of generic competition for Silenor; changes in healthcare reform measures and reimbursement policies; the ability of Somaxon to ensure adequate and continued supply of Silenor to successfully meet anticipated market demand; Somaxon’s ability to raise sufficient capital to fund its operations, 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, including any patent infringement litigation; the potential for an event of default under Somaxon’s loan agreement with Silicon Valley Bank and Oxford Finance Corporation, and the corresponding risk of acceleration of repayment and potential foreclosure on the assets pledged to secure the loan; Somaxon’s ability to operate its business without infringing the intellectual property rights of others; Somaxon’s reliance on its licensee, Paladin, for critical aspects of the commercial sales process for Silenor outside of the United States; the performance of Paladin and its adherence to the terms of its contracts with Somaxon; inadequate therapeutic efficacy or unexpected adverse side effects relating to Silenor that could adversely impact commercial success, 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 FDA’s agreement with Somaxon’s interpretation of such results; and other risks detailed in Somaxon’s 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 press 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.

Copyright Business Wire 2010

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