Business Development

We will consider opportunities to partner our products with other pharmaceutical companies where marketing and expanded reach to primary care physicians could expand the market penetration.

On January 31, 2008, we submitted a New Drug Application (NDA) for SILENOR^® to the U.S. Food and Drug Administration (FDA). We have successfully completed our four Phase 3 clinical trials for SILENOR (doxepin HCl tablets) in the treatment of insomnia. We designed our Phase 3 clinical program to facilitate regulatory approval and optimize marketing claims for this product candidate. While our efforts in commercializing SILENOR® would focus on psychiatrists and neurologists, we believe that the commercial success of SILENOR® will largely depend upon gaining access to primary care physicians, who according to IMS Health write more than 60% of prescriptions for insomnia. We are in discussions with a number of other pharmaceutical companies with the goal of optimizing the commercial success of SILENOR®. The outcome of this process could vary depending on the interest and objectives of the parties and may include a licensing transaction relating to SILENOR®, an acquisition of our business relating to SILENOR®, or a transaction to acquire our company as a whole. However, we cannot assure you that we will complete any strategic transaction, or that, if completed, any strategic transaction will be successful or on attractive terms.

We may also actively evaluate in-licensing of commercialized products and development-stage products in the fields of psychiatry and neurology.

If you have an interest in either becoming a strategic commercial partner of Somaxon or have product candidates that we might evaluate for in-licensing, please contact businessdev@somaxon.com or call 858-480-0400.