RESEARCH TRIANGLE PARK, N.C. & CHAPEL HILL, N.C.--(BUSINESS
WIRE)--Oct. 11, 2005--GlaxoSmithKline (NYSE: GSK) and POZEN Inc.
(NASDAQ: POZN), announced today that the New Drug Application (NDA)
for Trexima(TM) has been accepted for review by the U.S. Food and Drug
Administration (FDA). Trexima is the proposed brand name for the
combination of sumatriptan succinate, formulated with RT
Technology(TM), and naproxen sodium, in a single tablet for the acute
treatment of migraine. The NDA seeking marketing approval in the U.S.
was submitted on August 8, 2005. Pending FDA approval, the product
could be available to patients as early as second-half 2006.
"The Trexima NDA acceptance is an important milestone for POZEN,"
stated Dr. John Plachetka, POZEN's chairman, president and chief
executive officer. "We are pleased the FDA has accepted and is
currently reviewing the NDA for this innovative combination therapy."
"We are excited about the potential addition of Trexima to our
portfolio. This multi-mechanism migraine product may offer an
important treatment option for migraine sufferers," stated Stan Hull,
senior vice president, US Pharmaceuticals RTP, GlaxoSmithKline.
Pursuant to the terms of the agreement, a $20 million milestone
payment is payable to POZEN by GSK upon the FDA's acceptance for
review of the Trexima NDA.
Migraine affects more than 28 million people in the Unites States
alone, of which roughly three out of four migraine sufferers are
women. According to the International Headache Society's diagnostic
criteria, migraine is characterized by recurrent headaches lasting 4
to 72 hours (untreated) and with symptoms including moderate to severe
headache pain, throbbing head pain, head pain located on one side of
the head, head pain aggravated by routine activity, nausea, vomiting,
and sensitivity to light and sound. Migraine can be disabling and
sufferers may miss days of work, lose time with family and friends,
and be unable to pursue basic daily activities.
About Imitrex(R) (sumatriptan succinate) Tablets
Imitrex is a prescription medication indicated for the acute
treatment of migraine in adults. Imitrex should only be used when a
clear diagnosis of migraine has been established. 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. NSAIDs may cause increased risk of
serious cardiovascular thrombotic events, myocardial infarction and
stroke. This risk may increase with duration of use and in patients
with cardiovascular disease or risk factors for cardiovascular
disease. 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.
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 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 focused its efforts primarily on the development
of pharmaceutical products for the treatment of migraine. POZEN is
also exploring the development of product candidates in other
pain-related therapeutic areas. POZEN has development and a
commercialization alliance with GlaxoSmithKline. 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.
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 2004.
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 of our product candidates,
including as a result of the need to conduct additional studies, or
the failure to obtain such approval of our product candidates,
including as a result of changes in regulatory standards or the
regulatory environment during the development period of any 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 Quarterly Report
on Form 10-Q for the period ended June 30, 2005 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
Robin Gaitens, 919-483-2839
Frank Murdolo, 215-751-7002
Tom Curry, 215-751-5419
Bill Hodges, Chief Financial Officer, 919-913-1030
Fran Barsky, Director, Investor Relations, 919-913-1044
Andrea Johnston (media), 910-681-1088
SOURCE: POZEN Inc.