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EX-99.1 - EXHIBIT 99.1 - Pernix Sleep, Inc. | c17447exv99w1.htm |
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 13, 2011
SOMAXON PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware | 000-51665 | 20-0161599 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
3570 Carmel Mountain Road, Suite 100, San Diego, CA |
92130 |
|
(Address of principal executive offices) | (Zip Code) |
Registrants telephone number, including area code: (858) 876-6500
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01. Regulation FD Disclosure
The information attached as Exhibit 99.1 to this report relating to presentations of data from
the clinical trial program for Somaxon Pharmaceuticals, Inc.s (Somaxon) product Silenor®
(doxepin) 3 mg and 6 mg tablets will be presented at the American Psychiatric Association 164th
annual meeting in Honolulu, Hawaii (the Meeting), commencing May 17, 2011. The information
contained in Exhibit 99.1 to this report may also be presented from time to time by Somaxon at
various scientific, investor and analyst meetings after the Meeting.
The information in this Current Report on Form 8-K, including the information 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 herein
is summary information that is intended to be considered in the context of Somaxons 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.
Item 8.01 Other Events.
On May 13, 2011, Somaxon received a notice from Zydus Pharmaceuticals USA, Inc. (Zydus) that
it has filed with the U.S. Food and Drug Administration (the FDA) an Abbreviated New Drug
Application (ANDA) for a generic version of Silenor. This notice included a paragraph IV
certification with respect to eight of the nine patents listed in the FDAs Approved Drug Products
with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, for Silenor. A
paragraph IV certification is a certification by a generic applicant that in the opinion of that
applicant, the patent(s) listed in the Orange Book for a branded product are invalid,
unenforceable, and/or will not be infringed by the manufacture, use or sale of the generic product.
Somaxon is currently reviewing the details of the notice. Under the Hatch-Waxman Act, if
Somaxon initiates a patent infringement suit asserting infringement of any of the patents
identified in a paragraph IV notice within 45 days after its receipt of such notice, the FDA shall
not approve the ANDA until the earlier of 30 months, or a decision that all of such patents are not
infringed and/or invalid or unless either party to the action failed to cooperate reasonably to
expedite the infringement action.
Somaxon intends to vigorously enforce its intellectual property rights relating to Silenor,
but cannot predict the outcome of this matter or guarantee the outcome of any litigation. Silenor
is protected by nine patents covering approved methods of use of the product and its formulation,
all of which are listed in the Orange Book.
For a discussion of risks related to the ANDA filing by Zydus, as well as the ANDA filings
by Mylan Pharmaceuticals Inc., Par Pharmaceuticals, Inc. and Actavis Elizabeth LLC, see the
discussion of Intellectual Property under the Business section of Somaxons Annual Report on
Form 10-K for the year ended December 31, 2010 filed by Somaxon with the Securities and Exchange
Commission (the SEC) on March 4, 2011, the Risk Factors section of Somaxons Quarterly
Report on Form 10-Q for the period ended March 31, 2011 filed by Somaxon with the SEC on May 4,
2011, including the risk factor under the heading Restrictions on or challenges to our patent
rights relating to our products and limitations on or challenges to our other intellectual
property rights may limit our ability to prevent third parties from competing against us, and
the Current Reports on Form 8-K filed by Somaxon with the SEC on May 10, 2011 and May 12, 2011,
as well as any updates to such sections contained in Somaxons subsequent public disclosure
documents.
Somaxon cautions readers that statements included in this report that are not a description of
historical facts are forward-looking statements. For example, statements regarding Somaxons
intention to vigorously enforce its patent rights, the clinical data relating to Silenor and
Somaxons interpretation of such data 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 Somaxons business, including, without limitation,
Somaxons ability to successfully enforce its intellectual property rights and defend its patents;
the possible introduction of generic competition of Silenor; the scope, validity and duration of
patent protection to provide exclusivity for Silenor; inadequate therapeutic efficacy or unexpected
adverse side effects relating to Silenor 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 successfully commercialize
Silenor; Somaxons dependence on sales of Silenor; Somaxons reliance on its co-promotion partner,
Procter & Gamble, and its contract sales force provider, Publicis Touchpoint Solutions, 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
meet anticipated market demand; Somaxons ability to raise sufficient capital to fund its
operations, including any patent infringement litigation, 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; 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; and other risks detailed in Somaxons 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 report
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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. | Description | |||
99.1 | Somaxon Clinical Data Poster Presentations dated May 17, 2011 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
SOMAXON PHARMACEUTICALS, INC. |
||||
Date: May 17, 2011 | By: | /s/ Matthew W. Onaitis | ||
Name: | Matthew W. Onaitis | |||
Title: | Senior Vice President and General Counsel |
EXHIBIT INDEX
Exhibit No. | Description | |||
99.1 | Somaxon Clinical Data Poster Presentations dated May 17, 2011 |