2nd Aug 2007 13:31
GlaxoSmithKline PLC02 August 2007 FOR IMMEDIATE RELEASE FDA Issues Second Approvable Letter for TreximaTM GlaxoSmithKline (GSK) (LSE & NYSE: GSK) and POZEN Inc. (NASDAQ: POZN) announcedtoday (2nd August 2007) that the U.S. Food and Drug Administration (FDA) hasissued a second approvable letter for TreximaTM (sumatriptan/naproxen sodium).An approvable letter is an official notification from the FDA that containsconditions that must be satisfied prior to obtaining final U.S. marketingapproval. In January 2007, POZEN and GSK responded to the FDA's first approvable letter,submitting additional safety data from clinical trials, data from GSK'sdatabase, and additional in vitro preclinical data. In the second approvableletter, no additional information regarding the cardiovascular safety of Treximawas requested. The companies agreed to conduct a prospective study afterapproval to evaluate the effects on blood pressure during chronic, intermittenttreatment. The FDA has requested that POZEN further address the Agency's concern, prior toapproval, about the potential implications from one preclinical in vitrochromosomal aberration study (one of four standard genotoxicity assays) in whichgenotoxicity was seen for the combination of naproxen sodium and sumatriptan,but not with either component alone. None of the other three standardgenotoxicity studies (Ames test, mouse lymphoma TK assay, in vivo mousemicronucleus assay) demonstrated any genotoxicity for the combination ofnaproxen sodium and sumatriptan. The companies intend to request a meeting with the FDA as quickly as possible todiscuss the necessary steps to address the Agency's concerns. Trexima was the proposed brand name for the product candidate combiningsumatriptan 85 mg, as the succinate salt, formulated with RT TechnologyTM andnaproxen sodium 500 mg in a single tablet. Several new names are underconsideration at FDA, but pending a final decision on a new name the productwill still be referred to as Trexima. The FDA had previously determined that Trexima is effective as an acutetreatment for migraine headaches. POZEN and GSK will continue to work with theFDA 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 ofmigraine in adults. Imitrex should only be used when a clear diagnosis ofmigraine has been established. Patients should not take Imitrex if they havecertain types of heart disease, history of stroke or TIAs, peripheral vasculardisease, Raynaud syndrome, or blood pressure that is uncontrolled. Patients withrisk 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 seriousheart related problems. Patients who are pregnant, nursing, or takingmedications should talk to their doctor. About Naproxen Sodium Naproxen sodium is a non-steroidal anti-inflammatory drug (NSAID) and iscontained in Anaprox(R), Anaprox DS(R), Naprelan(R), Aleve(R) and in a number ofover-the-counter medications. Naproxen sodium is indicated for the treatment ofrheumatoid arthritis, osteoarthritis, ankylosing spondylitis and juvenilearthritis. It is also indicated for the treatment of tendinitis, bursitis, acutegout and for the management of pain and primary dysmenorrhea.Naproxen-containing products should not be used by patients who have hadallergic reactions to any product containing naproxen, nor in patients in whomaspirin or other NSAIDs induce the syndrome of asthma, rhinitis, and nasalpolyps. Patients who have a history of peptic ulcer or gastrointestinalbleeding, kidney problems, uncontrolled hypertension or heart failure shouldconsult a physician before using naproxen-containing medications. NSAIDs maycause increased risk of serious cardiovascular thrombotic events, myocardialinfarction and stroke. This risk may increase with duration of use and inpatients with cardiovascular disease or risk factors for cardiovascular disease.Serious gastrointestinal toxicity such as bleeding, ulceration and perforationcan occur at any time in patients treated chronically with NSAID therapy andphysicians should remain alert for such effects even in the absence of previousGI tract symptoms. Patients who are pregnant or are nursing should consult aphysician before use of a naproxen-containing medication. About GlaxoSmithKline (LSE & NYSE: GSK) GlaxoSmithKline - one of the world's leading research-based pharmaceutical andhealthcare companies - is committed to improving the quality of human life byenabling people to do more, feel better and live longer. For detailed companyinformation, see GlaxoSmithKline's website: www.gsk.com. Cautionary statement regarding forward-looking statements Under the safe harbor provisions of the U.S. Private Securities LitigationReform Act of 1995, the company cautions investors that any forward-lookingstatements or projections made by the company, including those made in thisAnnouncement, are subject to risks and uncertainties that may cause actualresults to differ materially from those projected. Factors that may affect theGroup'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 therapeuticadvancements for diseases with unmet medical needs where it can improveefficacy, safety, and/or patient convenience. Since its inception, POZEN hasfocused its efforts primarily on the development of pharmaceutical products forthe treatment of acute and chronic pain, migraine and other pain relatedconditions. POZEN is also exploring the development of product candidates inother pain-related therapeutic areas. POZEN has development and acommercialization alliance with GlaxoSmithKline. The company's common stock istraded on The Nasdaq Stock Market under the symbol "POZN". For detailed companyinformation, including copies of this and other press releases, see POZEN'swebsite: 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" provisionsof the Private Securities Litigation Reform Act of 1995. You should be awarethat POZEN's actual results could differ materially from those contained in theforward-looking statements, which are based on management's current expectationsand are subject to a number of risks and uncertainties, including, but notlimited to those discussed in our Quarterly Report on Form 10-Q for the periodended March 31, 2007. Enquiries: GlaxoSmithKline UK Media: Philip Thomson (020) 8047 5502 Claire Brough (020) 8047 5502 Joss Mathieson (020) 8047 5502 US Media: Nancy Pekarek (215) 751 7709 Alice Hunt (215) 751 7709 European Analyst/Investor: Sally Ferguson (020) 8047 5543 David Mawdsley (020) 8047 5564 US Analyst/ Investor: Frank Murdolo (215) 751 7002 Tom Curry (215) 751 5419 Pozen IncInvestors Bill Hodges (919) 913 1030 Chief Financial Officer, Media Fran Barsky, (919) 913 1044 Director, Investor Relations Sheryl Seapy, (949) 608 0841 Pure Communications, This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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