Item 7.01. Regulation FD Disclosure
Somaxon Pharmaceuticals, Inc. hosted a conference call on November 24, 2008
at 9:00 a.m. Eastern time to provide an update on the review by the U.S. Food
and Drug Administration of the company's New Drug Application for Silenor®
(doxepin). The conference call transcript is attached hereto as Exhibit 99.1 and
is incorporated herein by reference.
A telephonic replay will be available for approximately one week following
the conclusion of the call by dialing (800) 405-2236 (domestic) or
(303) 590-3000 (international), and entering passcode 11122746. The call will be
archived and accessible at www.somaxon.com for approximately two weeks.
The information in this Current Report on Form 8-K, including the transcript
attached hereto as Exhibit 99.1, is being furnished pursuant to this Item 7.01
and shall not be deemed "filed" for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to
the liabilities of that section, and it shall not be deemed incorporated by
reference in any filing under the Securities Act of 1933, as amended, or under
the Exchange Act, whether made before or after the date hereof, except as
expressly set forth by specific reference in such filing to this Current Report
on Form 8-K.
By filing this Current Report on Form 8-K and furnishing this information,
Somaxon makes no admission as to the materiality of any information in this
report. The information contained in the transcript is summary information that
is intended to be considered in the context of Somaxon's filings with the SEC
and other public announcements that Somaxon makes, by press release or
otherwise, from time to time. Somaxon undertakes no duty or obligation to
publicly update or revise the information contained in this report, although it
may do so from time to time as its management believes is appropriate. Any such
updating may be made through the filing of other reports or documents with the
SEC, through press releases or through other public disclosure.
Somaxon cautions you that statements included in this report that are not a
description of historical facts are forward-looking statements. The inclusion of
forward-looking statements should not be regarded as a representation by Somaxon
that any of its plans will be achieved. Actual results may differ materially
from those set forth in this report due to the risks and uncertainties inherent
in Somaxon's business, including, without limitation, the potential for Silenor
to receive regulatory approval for one or more indications on a timely basis or
at all; the potential for the FDA to impose non-clinical, clinical or other
requirements to be completed before or after regulatory approval of Silenor;
Somaxon's ability to demonstrate to the satisfaction of the FDA that potential
NDA approval of Silenor is appropriate prior to the completion of standard,
long-term carcinogenicity studies, given the context of completed trials and
pending studies; the timing and results of non-clinical studies for Silenor, and
the FDA's agreement with Somaxon's interpretation of such results; Somaxon's
ability to successfully commercialize Silenor, if it is approved by the FDA;
Somaxon's ability to raise sufficient capital and meet its obligations to
parties with whom it contracts relating to financing activity, and the impact of
any such financing activity on the level of Somaxon's stock price; the potential
to enter into and the terms of any strategic transaction relating to Silenor;
the scope, validity and duration of patent protection and other intellectual
property rights for Silenor; whether any approved label for Silenor is
sufficiently consistent with such patent protection to provide exclusivity for
Silenor; Somaxon's ability to operate its business without infringing the
intellectual property rights of others; unexpected findings relating to Silenor
that could delay or prevent regulatory approval or commercialization, or that
could result in recalls or product liability claims; other difficulties or
delays in development, testing, manufacturing and marketing of and obtaining
regulatory approval for Silenor; the market potential for insomnia treatments,
and Somaxon's ability to compete within that market; and other risks detailed in
Somaxon's prior press releases as well as in its periodic filings with the
Securities and Exchange Commission. You 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 report to reflect events or circumstances after the date hereof. This
caution is made under the safe harbor provisions of Section 21E of the Exchange
Act.