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GlaxoSmithKline and POZEN Announce Trexima(TM) (Sumatriptan Succinate and Naproxen Sodium) New Drug Application Accepted for Review by FDA.


RESEARCH TRIANGLE PARK Research Triangle Park, research, business, medical, and educational complex situated in central North Carolina. It has an area of 6,900 acres (2,795 hectares) and is 8 × 2 mi (13 × 3 km) in size. Named for the triangle formed by Duke Univ. , N.C. & CHAPEL HILL, N.C. -- GlaxoSmithKline (NYSE NYSE

See: New York Stock Exchange
: GSK GSK GlaxoSmithKline plc (pharmaceutical company)
GSK Glycogen Synthase Kinase
GSK Gruppentraining Sozialer Kompetenzen (Germany)
GSK Greenland Shark (FAO fish species code) 
) and POZEN Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: POZN), announced today that the New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for Trexima(TM) has been accepted for review by the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
). 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 (1) (Rapid Transport Protocol) The protocol used in IBM's High Performance Routing (HPR) system.

(2) (Realtime Transport Protocol) An IP protocol that supports real time transmission of voice and video.
, 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.

About Migraine

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 throb  
intr.v. throbbed, throb·bing, throbs
1. To beat rapidly or violently, as the heart; pound.

2. To vibrate, pulsate, or sound with a steady pronounced rhythm:
 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 Peripheral Vascular Disease Definition

Peripheral vascular disease is a narrowing of blood vessels that restricts blood flow. It mostly occurs in the legs, but is sometimes seen in the arms.
, 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 Non-steroidal anti-inflammatory drugs, usually abbreviated to NSAIDs, are drugs with analgesic, antipyretic and anti-inflammatory effects - they reduce pain, fever and inflammation.  (NSAID NSAID: see nonsteroidal anti-inflammatory drug. ) 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 bursitis (bərsī`təs), acute or chronic inflammation of a bursa, or fluid sac, located close to a joint. In response to irritation or injury the bursa may become inflamed, causing pain, restricting motion, and producing more fluid than can , acute gout gout, condition that manifests itself as recurrent attacks of acute arthritis, which may become chronic and deforming. It results from deposits of uric acid crystals in connective tissue or joints.  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 naproxen and naproxen sodium, potent nonsteroidal anti-inflammatory drugs (NSAID) used to alleviate the minor pain of arthritis, menstruation, headaches, and the like, and to reduce fever. , nor in patients in whom aspirin or other NSAIDs induce the syndrome of asthma, rhinitis Rhinitis Definition

Rhinitis is inflammation of the mucous lining of the nose.
Description

Rhinitis is a nonspecific term that covers infections, allergies, and other disorders whose common feature is the location of their symptoms.
, 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 per·fo·ra·tion
n.
1. The act of perforating or the state of being perforated.

2. An abnormal opening in a hollow organ or viscus, as one made by rupture or injury.


Perforation
A hole.
 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

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.

About POZEN

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 Nasdaq stock market

The first electronic stock market listing over 5000 companies. The Nasdaq stock market comprises two separate markets, namely the Nasdaq National Market, which trades large, active securities and the Nasdaq Smallcap Market that trades emerging growth companies.
 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 Management's discussion and analysis (MD&A)

A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial
 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.
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Publication:Business Wire
Geographic Code:1USA
Date:Oct 11, 2005
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