UNITED STATES
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
Date of Report (Date of earliest event reported): February 28, 2005
Commission File Number 000-31719
POZEN Inc.
(Exact name of registrant as specified in its charter)
Delaware 62-1657552
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
1414 Raleigh Road
Suite 400
Chapel Hill, North Carolina 27517
(Address of principal executive offices, including zip code)
(919) 913-1030
(Registrant's telephone number, including area code)
Item 2.02. Results of Operations and Financial Condition.
On February 28, 2005, POZEN Inc. issued a press release to report the
company's financial results for the quarter and year ended December 31, 2004. A
copy of the press release is attached to this current report on Form 8-K as
Exhibit 99.1.
The information provided under Item 2.02 of this Form 8-K shall not be
deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934
(the "Exchange Act") or otherwise subject to the liabilities of that section,
nor shall it be deemed incorporated by reference in any filing under the
Securities Act of 1933 or the Exchange Act, except as expressly set forth by
specific reference in such a filing.
Item 8.01 Other Events.
On February 28, 2005, POZEN issued a press release to report that the
company completed the first of two Phase III pivotal trials for Trexima(TM) for
the treatment of migraine headaches. Trexima is GlaxoSmithKline's (GSK) proposed
brand name for the combination of sumatriptan formulated with RT Technology(TM)
and naproxen sodium in a single tablet. GSK and POZEN are collaborating on the
development of Trexima.
Trexima demonstrated superiority over the individual components measured by
sustained pain-free response (p<.001) and, with the exception of the incidence
of nausea-free at two hours, all other regulatory endpoints were met (p <.001).
Trexima did reach statistical significance for the nausea endpoint compared to
placebo after two hours and maintained superiority through twenty-four hours.
All of the active treatments (Trexima, sumatriptan and naproxen) had a similar
incidence of nausea at two hours compared to placebo. Submission of the new drug
application (NDA) with the U.S. Food and Drug Administration is planned for the
second half of 2005.
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 thereunto duly authorized.
POZEN Inc.
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(Registrant)
February 28, 2005 /s/ William L. Hodges
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William L. Hodges
Chief Financial Officer
EXHIBIT INDEX
The following exhibit is furnished as part of this current report on Form 8-K:
Exhibit
Number Description
- ------- -----------
99.1 Press release of POZEN Inc. dated February 28, 2005.