20th Sep 2006 07:01
Vernalis PLC20 September 2006 20 September 2006 Vernalis plc Announces FDA Acceptance for Filing of Frova(R) for Short-Term Prevention of Menstrual Migraine WINNERSH, U.K., 20 September 2006 -- Vernalis plc (LSE: VER, Nasdaq: VNLS) todayannounced that the U.S. Food and Drug Administration (FDA) has accepted forfiling the supplemental New Drug Application (sNDA) for Frova(R) (frovatriptansuccinate) 2.5 mg tablets for the short-term (six days per month) prevention ofmenstrual migraine (MM). Acceptance for filing indicates recognition by the FDAthat the submission is complete and warrants full review of the data needed toassess the safety and efficacy of Frova(R) for the short-term prevention of MM. Under the Prescription Drug User Fee Act (PDUFA) guidelines, the FDA is expectedto complete its review within ten months from the sNDA submission date.Vernalis' partner, Endo Pharmaceuticals Inc., submitted the application on 19July 2006. The FDA has confirmed 19 May 2007 as the review completion date forthis application. -- ends -- Enquiries: Vernalis plc +44 (0) 118 977 3133Simon Sturge, Chief Executive OfficerTony Weir, Chief Financial OfficerJulia Wilson, Head of Corporate Communications Brunswick Group +44 (0) 20 7404 5959Jon ColesJustine McIlroy Lazar Partners Ltd +1-212-867-1762Gregory Gin Notes to Editors The sNDA for Frova(R) is supported by data from four studies, including twoPhase III studies examining the efficacy and safety of once- and twice-dailydose regimens of Frova(R) in the short-term prevention of MM, a pharmacokineticsand tolerability study of once- and twice-daily dosing of Frova(R), and a12-month open-label safety study evaluating a six-day dosing regimen of Frova(R)in 525 women. Important Information about Frova(R) Frova(R) was approved by the FDA on November 8, 2001 for the acute treatment ofmigraine attacks with or without aura (subjective symptoms at the onset of amigraine headache) in adults. Frova(R) is generally well tolerated, with aside-effect profile that is typical of the triptan class of drugs. Frova(R) isindicated for the acute treatment of migraine attacks with or without aura inadults where a clear diagnosis of migraine has been established. Frova(R) isnot intended for the prophylactic treatment of migraine or for use in themanagement of hemiplegic or basilar migraine. The safety and effectiveness ofFrova(R) have not been established for cluster headache, which is present in anolder, predominantly male population. Frova(R) should not be given to patients with cerebrovascular syndromes,peripheral vascular disease, uncontrolled hypertension, ischemic heart disease,or to patients who have symptoms or findings consistent with ischemic heartdisease, coronary artery vasospasm, including Prinzmetal's variant angina orother significant underlying cardiovascular disease. Frova(R) should not begiven to patients within whom unrecognized coronary artery disease is predictedby the presence of risk factors without a prior cardiovascular evaluation. The most common adverse events (4%) include dizziness, fatigue, paresthesia,flushing, and headache. The FDA-approved dosing for Frova(R) is one 2.5 mg tablet up to three timeswithin a 24-hour period. Frova(R) is not currently approved by the FDA for anyindications other than for the treatment of acute migraine headaches, and itssafety and efficacy in other indications have not been established. Frova(R) is licensed for this indication in the US. For other countries, checklocal prescribing information. Not necessarily licensed for this indicationoutside the US. Not for release in the UK. About Menstrual Migraine Menstrual Migraine (MM) can have a serious impact on women's lives because theylast longer than non-menstrual migraines, tend to be associated with severe painand recur more often. Patients with MM may suffer from migraines at any time,although their migraine is frequently linked to their menstrual cycle. Over 60percent of migraines in women are associated with menstruation. About Vernalis Vernalis is a speciality bio-pharmaceutical company focused on products marketedto specialist neurologists. The company has two marketed products, Frova(R) andApokyn(R), and a development pipeline focused on neurology and central nervoussystem disorders. The company has seven products in clinical development andcollaborations with leading, global pharmaceutical companies including Novartis,Biogen Idec and Serono. Vernalis has established a US commercial operation topromote Apokyn(R) and co-promote Frova(R) alongside its North American licensingpartner, Endo Pharmaceuticals, progressing the company towards its goal ofbecoming a sustainable, self-funding, R&D-driven, speciality bio-pharmaceuticalcompany. For further information about Vernalis, please visit www.vernalis.com Vernalis Forward-Looking Statement This news release may contain forward-looking statements that reflect theCompany's current expectations regarding future events including the clinicaldevelopment and regulatory clearance of the Company's products and includingthat of Frova(R) for menstrual migraine, the Company's ability to find partnersfor the development and commercialisation of its products, the benefits ofre-acquiring Frova(R) in North America and the partnership with Endo on theCompany's liquidity and results of operations, as well as the Company's futurecapital raising activities. Forward-looking statements involve risks anduncertainties. Actual events could differ materially from those projected hereinand depend on a number of factors including the success of the Company'sresearch strategies, the applicability of the discoveries made therein, thesuccessful and timely completion of clinical studies, including with respect toFrova(R) and the Company's other products, the uncertainties related to theregulatory process, the ability of the Company to identify and agree beneficialterms with suitable partners for the commercialisation and/or development ofFrova(R) and other products, as well as the achievement of expected synergiesfrom such transactions, the acceptance of Frova(R) and other products byconsumers and medical professionals, the successful integration of completedmergers and acquisitions and achievement of expected synergies from suchtransactions, and the ability of the Company to identify and consummate suitablestrategic and business combination transactions. 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