Somaxon (SOMX) Gets Silenor Guidance from FDA in OTC Development; Appoints New Sales SVP

Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), 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 (NYSE: PG), the FDA provided clinical and regulatory guidance that the company believes provides a clear path forward toward an OTC version of Silenor.

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.

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.

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