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8-K - FORM 8-K - Pernix Sleep, Inc. | c05383e8vk.htm |
EX-10.1 - EXHIBIT 10.1 - Pernix Sleep, Inc. | c05383exv10w1.htm |
Exhibit 99.1
Contacts: | Tran Nguyen / CFO Somaxon Pharmaceuticals, Inc. (858) 876-6500 Rob Whetstone PondelWilkinson, Inc. (310) 279-5963 Investors@somaxon.com |
SOMAXON PHARMACEUTICALS ANNOUNCES
SILENOR® CO-PROMOTION AGREEMENT
WITH PROCTER & GAMBLE
SILENOR® CO-PROMOTION AGREEMENT
WITH PROCTER & GAMBLE
| Combined Sales Forces to Launch Silenor to Physicians in September | |
| Procter & Gamble to Provide Pharmacy Calls and Supplemental Managed Care Support | |
| Silenor OTC Negotiation Rights Included | |
| Conference Call Scheduled for Today at 9:00 a.m. Eastern |
SAN DIEGO, CA August 25, 2010 Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) today announced
that Somaxon and Procter & Gamble (NYSE: PG) 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 U.S. market. Procter & Gambles professional health care
sales force will promote Silenor to target primary care and other high-prescribing physicians.
Somaxons 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 U.S.
We are extremely excited to add Procter & Gambles highly regarded and tenured professional sales
force to our commercialization effort for Silenor, said Richard W. Pascoe, Somaxons 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
Cares current and future business interests, and we are confident P&Gs 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 U.S. 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 U.S. 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.
Conference Call Information and Forward-Looking Statements
On Wednesday, August 25, 2010, Somaxon will conduct a conference call with interested parties
beginning at 9:00 a.m. ET (6:00 a.m. PT) to discuss the contents of this press release.
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 for approximately two weeks. Alternatively, callers may participate in the conference
call by dialing (480) 629-9822. A telephonic replay will be available for approximately one week
following the conclusion of the call by dialing (303) 590-3030, and entering passcode 4356913.
Discussion during the conference call may include forward-looking statements regarding such topics
as, but not limited to, commercialization plans for Silenor®, Somaxons financial status and
performance and any comments Somaxon may make about its future plans or prospects in response to
questions from participants on the conference call.
About Silenor®
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
companys development program, including data from Somaxons clinical trial program that evaluated
1,017 subjects exposed to Silenor from 12 studies.
Important Safety Information
A doctor should be consulted if insomnia worsens or is not better within 7 to 10 days. This may
mean that there is another condition causing the sleep problem.
Patients should be sure that they are able to devote 7 to 8 hours to sleep before being active
again. Silenor should be taken within 30 minutes of bedtime. Patients should not take Silenor with
alcohol or with other medicines that can cause drowsiness. Silenor should not be taken with or
within two weeks after taking a monoamine oxidase inhibitor (MAOI). Patients should not take
Silenor if they have untreated narrow angle glaucoma, if they have severe urinary retention, if
they have severe sleep apnea or if they are allergic to any of the ingredients in Silenor. Until
patients know how they will react to Silenor, they should not drive or operate machinery at night
after taking Silenor, and they should be careful in performing such activities during the day
following taking Silenor. Before taking Silenor, patients should tell their doctors if they have a
history of depression, mental illness or suicidal thoughts. Patients should call their doctors
right away if after taking Silenor they walk, drive, eat or engage in other activities while
asleep. Drowsiness was the most common adverse event observed in clinical trials.
For more information, please see the complete Prescribing Information, including the Medication
Guide, at www.silenor.com or www.somaxon.com.
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
pharmaceutical products and late-stage product candidates for the treatment of diseases and
disorders in the central nervous system therapeutic area. Somaxons product Silenor® (doxepin) has
been approved by the FDA for the treatment of insomnia characterized by difficulty with sleep
maintenance.
For more information, please visit the companys web site at www.somaxon.com.
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 commercialization of Silenor, including the number of sales
representatives to be deployed and the numbers of physicians and pharmacies to be targeted, the
potential to license over-the-counter rights to Silenor to Procter & Gamble, and Somaxons
operating expense guidance are forward-looking statements. The inclusion of forward-looking
statements should not be regarded as a representation by Somaxon that its plans will be achieved.
Actual results may differ materially from those set forth in this release due to the risks and
uncertainties inherent in Somaxons business, including, without limitation, Somaxons ability to
successfully commercialize Silenor; Somaxons reliance on third parties, Procter & Gamble and
Publicis, for critical aspects of the commercial sales process for Silenor; the performance of
Procter & Gamble and Publicis and their adherence to the terms of their contracts with Somaxon; the
ability of Somaxons sales management personnel to effectively manage the sales representatives
employed by Publicis; the ability of Somaxon to ensure adequate and continued supply of Silenor to
successfully launch commercial sales or meet anticipated market demand; 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; Somaxons ability to operate its business without infringing the
intellectual property rights of others; the market potential for insomnia treatments, and Somaxons
ability to compete within that market;
inadequate therapeutic efficacy or unexpected adverse side effects relating to Silenor that could
delay or prevent commercialization, 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 FDAs agreement
with Somaxons interpretation of such results; Somaxons 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; and other risks
detailed in Somaxons 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.
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