CHAPEL HILL & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--May
18, 2004--POZEN (NASDAQ: POZN) and GlaxoSmithKline (NYSE: GSK) today
announced the start of the Phase III program for Trexima(TM). Trexima
is the proposed brand name for the combination of sumatriptan
(5-HT1B/1D agonist) and naproxen sodium in a single tablet.
The Phase III program will begin immediately. POZEN will conduct
two Phase III pivotal trials, designed to determine the effectiveness
and safety of Trexima for the acute treatment of migraine. In
addition, POZEN will conduct a long-term, open label safety study.
"Moving into Phase III is a major step in the development of this
important new medicine," said Stan Hull, GSK Senior Vice President, US
Pharmaceuticals. "GSK has long been a leader in discovering and
developing migraine treatments, and we are pleased to be working with
POZEN to move Trexima into the final stage of development."
"We look forward to a rapid development program for Trexima, with
a targeted NDA filing in the second half of 2005. We believe Trexima,
which uses POZEN's MT 400(TM) technology, has the potential to be one
of the best treatments for migraine," said John R. Plachetka,
Pharm.D., POZEN's Chairman, President and Chief Executive Officer.
POZEN and GSK signed an agreement in June 2003 for the development
and commercialization of proprietary combinations of a triptan
(5-HT1B/1D agonist) and a non-steroidal anti-inflammatory drug
(NSAID), including the combination that makes up Trexima. Under the
agreement, POZEN is responsible for the pre-clinical, clinical, and
regulatory development activities for Trexima, while GSK is
responsible for formulation development, manufacturing and
commercialization. The commencement of the Phase III program will
trigger a $15 million development milestone payment to POZEN by GSK.
The companies expect the New Drug Application (NDA) for Trexima to be
filed in the second half of 2005.
Migraine afflicts approximately 28 million people in the United
States alone, of which roughly three out of four migraine sufferers
are women. Migraine attacks can last from 4 hours to 72 hours and are
typically characterized by sharp pulsating pain on one side of the
head, nausea, and extreme sensitivity to light and sound. While the
precise mechanism of migraine is unknown, researchers believe migraine
attacks are caused by acute inflammation surrounding selected vessels
in the head. The average migraine sufferer experiences the first
attack during the early teen years, and the attacks generally continue
Imitrex (sumatriptan) tablets are approved for the acute treatment
of migraines with or without aura in adults and are available by
prescription in pharmacies nationwide. Imitrex should only be used
when a clear diagnosis of migraine has been established by a
physician. Patients should not take Imitrex if they have certain types
of heart disease, history of stroke or TIAs, peripheral vascular
disease, Raynaud syndrome, or blood pressure that is uncontrolled.
Patients with risk factors for heart disease, such as high blood
pressure, high cholesterol, diabetes or are a smoker, should be
evaluated by a doctor before taking Imitrex. Very rarely, certain
people, even some without heart disease, have had serious heart
related problems. Patients who are pregnant, nursing, or taking
medications should talk to their doctor.
About Naproxen Sodium
Naproxen sodium is a non-steroidal anti-inflammatory drug (NSAID)
and is contained in Anaprox(R), Anaprox DS(R), Naprelan(R), Aleve(R)
and in a number of over-the-counter medications. Naproxen sodium is
indicated for the treatment of rheumatoid arthritis, osteoarthritis,
ankylosing spondylitis and juvenile arthritis. It is also indicated
for the treatment of tendinitis, bursitis, acute gout and for the
management of pain and primary dysmenorrhea. Naproxen-containing
products should not be used by patients who have had allergic
reactions to any product containing naproxen, nor in patients in whom
aspirin or other NSAIDs induce the syndrome of asthma, rhinitis, and
nasal polyps. Patients who have a history of peptic ulcer or
gastrointestinal bleeding, kidney problems, uncontrolled hypertension
or heart failure should consult a physician before using
naproxen-containing medications. Serious gastrointestinal toxicity
such as bleeding, ulceration and perforation can occur at any time in
patients treated chronically with NSAID therapy and physicians should
remain alert for such effects even in the absence of previous GI tract
symptoms. Patients who are pregnant or are nursing should consult a
physician before use of a naproxen-containing medication.
POZEN is a pharmaceutical company committed to developing
therapeutic advancements for diseases with unmet medical needs where
it can improve efficacy, safety, and/or patient convenience. Since its
inception, POZEN has developed what it believes to be one of the
largest and most advanced product pipelines in the field of migraine.
POZEN has development and commercial alliances with GlaxoSmithKline,
Xcel Pharmaceuticals, and Nycomed. The company's common stock is
traded on The Nasdaq Stock Market under the symbol "POZN". For
detailed company information, including copies of this and other press
releases, see POZEN's website: www.pozen.com.
GlaxoSmithKline - one of the world's leading research-based
pharmaceutical and healthcare companies - is committed to improving
the quality of human life by enabling people to do more, feel better
and live longer. For detailed company information, see
GlaxoSmithKline's website: www.gsk.com.
POZEN forward looking statements
Statements included in this press release that are not historical
in nature are "forward-looking statements" within the meaning of the
"safe harbor" provisions of the Private Securities Litigation Reform
Act of 1995. You should be aware that our actual results could differ
materially from those contained in the forward-looking statements,
which are based on management's current expectations and are subject
to a number of risks and uncertainties, including, but not limited to,
our failure to successfully commercialize our product candidates;
costs and delays in the development and/or FDA approval, or the
failure to obtain such approval of our product candidates;
uncertainties in clinical trial results or the timing of such trials,
resulting in, among other things, an extension in the period over
which we recognize deferred revenue or our failure to achieve
milestones that would have provided us with revenue; our inability to
maintain or enter into, and the risks resulting from our dependence
upon, collaboration or contractual arrangements necessary for the
development, manufacture, commercialization, marketing, sales and
distribution of any products; competitive factors; our inability to
protect our patents or proprietary rights and obtain necessary rights
to third party patents and intellectual property to operate our
business; our inability to operate our business without infringing the
patents and proprietary rights of others; general economic conditions;
the failure of any products to gain market acceptance; our inability
to obtain any additional required financing; technological changes;
government regulation; changes in industry practice; and one-time
events, including those discussed herein and in our Form 10-Q for the
quarter ended March 31, 2004 under "Management's Discussion and
Analysis of Financial Condition and Results of Operations." We do not
intend to update any of these factors or to publicly announce the
results of any revisions to these forward-looking statements.
GSK Cautionary Statement regarding forward-looking statements:
Under the safe harbor provisions of the US Private Securities
Litigation Reform Act of 1995, GSK cautions investors that any
forward-looking statements or projections made by the company,
including those made in this Announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from
those projected. Factors that may affect the Group's operations
include, but are not limited to, those described under 'Risk Factors'
in the Operating and Financial Review and Prospects in GSK's Annual
Report on Form 20-F for 2002.
CONTACT: POZEN Inc.
Lisa Barthelemy, Director, IR, 919-913-1044
John Barnhardt, VP Finance and Administration,
Kathy Jones, Ph.D. (media), 212-213-0006, ext. 39
US Media: Ramona DuBose, 919-483-2839
US Analyst/Investor: Frank Murdolo, 215-751-7002 or
Tom Curry, 215-751-5419
SOURCE: POZEN Inc.