Trexima FDA Approvable Letter

GlaxoSmithKline PLC
02 August 2007


FOR IMMEDIATE RELEASE

               FDA Issues Second Approvable Letter for TreximaTM

GlaxoSmithKline (GSK) (LSE & NYSE: GSK) and POZEN Inc. (NASDAQ: POZN) announced
today (2nd August 2007) that the U.S. Food and Drug Administration (FDA) has
issued a second approvable letter for TreximaTM (sumatriptan/naproxen sodium).
An approvable letter is an official notification from the FDA that contains
conditions that must be satisfied prior to obtaining final U.S. marketing
approval.

In January 2007, POZEN and GSK responded to the FDA's first approvable letter,
submitting additional safety data from clinical trials, data from GSK's
database, and additional in vitro preclinical data.  In the second approvable
letter, no additional information regarding the cardiovascular safety of Trexima
was requested.  The companies agreed to conduct a prospective study after
approval to evaluate the effects on blood pressure during chronic, intermittent
treatment.

The FDA has requested that POZEN further address the Agency's concern, prior to
approval, about the potential implications from one preclinical in vitro
chromosomal aberration study (one of four standard genotoxicity assays) in which
genotoxicity was seen for the combination of naproxen sodium and sumatriptan,
but not with either component alone.  None of the other three standard
genotoxicity studies (Ames test, mouse lymphoma TK assay, in vivo mouse
micronucleus assay) demonstrated any genotoxicity for the combination of
naproxen sodium and sumatriptan.

The companies intend to request a meeting with the FDA as quickly as possible to
discuss the necessary steps to address the Agency's concerns.

Trexima was the proposed brand name for the product candidate combining
sumatriptan 85 mg, as the succinate salt, formulated with RT TechnologyTM and
naproxen sodium 500 mg in a single tablet.  Several new names are under
consideration at FDA, but pending a final decision on a new name the product
will still be referred to as Trexima.

The FDA had previously determined that Trexima is effective as an acute
treatment for migraine headaches. POZEN and GSK will continue to work with the
FDA on revisions to the proposed package insert and the proposed trade name.

S M Bicknell

Company Secretary

2nd August 2007



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.

About GlaxoSmithKline (LSE & NYSE: GSK)

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.



Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995, the company 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 are described under 'Risk Factors' in the 'Business Review'
in the company's Annual Report on Form 20-F for 2006.



About POZEN (NASDAQ: POZN)

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 acute and chronic pain, migraine and other pain related
conditions. 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.



Safe Harbor Statement

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 POZEN's 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 those discussed in our Quarterly Report on Form 10-Q for the period
ended March 31, 2007.

Enquiries:


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