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.