Somaxon Pharmaceuticals, Inc. announced that Somaxon and Procter & Gamble (P&G) have entered into a co-promotion agreement for Silenor (doxepin), a newly-approved treatment for insomnia characterized by difficulty with sleep maintenance.
Under the terms of the agreement, Somaxon and Procter & Gamble will co-promote Silenor with a combined 215 sales representatives in the US market. Procter & Gamble’s professional health care sales force will promote Silenor to targeted primary care and other high-prescribing physicians. Somaxon’s focus will be on specialists and other top-decile physicians who treat insomnia. In addition, Procter & Gamble will promote Silenor to targeted pharmacies and will provide supplemental managed care support services for Silenor.
Somaxon has also granted Procter & Gamble a right of first negotiation relating to rights to develop and market Silenor as an over-the-counter medication in the US.
“We are extremely excited to add Procter & Gamble’s highly regarded and tenured professional sales force to our commercialization effort for Silenor,” said Richard W. Pascoe, Somaxon’s president and chief executive officer. “With the combined effort of both sales forces, we will target 35,000 of the highest prescribers of insomnia products as well as 25,000 pharmacies, which we believe will allow us to be highly competitive in the insomnia market. In addition, we are excited about the potential to partner with Procter & Gamble for the OTC rights to Silenor as a future life cycle management opportunity.”
“We are thrilled to partner with Somaxon to co-promote Silenor,” said Thomas M. Finn, president, Global Health Care at Procter & Gamble. “This opportunity is an excellent fit with P&G Health Care’s current and future business interests, and we are confident P&G’s professional sales force will help Silenor deliver both for patients and in the marketplace.”
Somaxon will record all sales of Silenor and will pay Procter & Gamble a combination of fixed fees and a royalty based on US net sales. Each party will be responsible for the costs of maintaining and operating its own sales force, and Somaxon is responsible for all other costs pertaining to the commercialization of Silenor. The term of the agreement runs through December 31, 2012, renewable thereafter, and Somaxon will pay Procter & Gamble a reduced royalty based on US net sales of Silenor for one year after the expiration of the agreement or its earlier termination under certain circumstances. Governance of the collaboration will occur through a joint commercialization committee.
Silenor is a low-dose (3 mg, 6 mg) oral tablet formulation of doxepin that is patent protected for use in insomnia. The Silenor NDA was approved in March 2010 for the treatment of insomnia characterized by difficulties with sleep maintenance. The NDA included all of the data from the company’s development programme, including data from Somaxon’s clinical trial programme that evaluated 1,017 subjects exposed to Silenor from 12 studies.