20th Jul 2006 07:00
Vernalis PLC20 July 2006 For Immediate Release ENDO PHARMACEUTICALS AND VERNALIS PLC ANNOUNCE THE FILING OF THE SUPPLEMENTAL NDA FOR FROVA(R) FOR SHORT-TERM PREVENTION OF MENSTRUAL MIGRAINE CHADDS FORD, Pa., and WINNERSH, U.K., July 19, 2006 - Endo PharmaceuticalsHoldings Inc. (Nasdaq: ENDP) and Vernalis plc (LSE: VER, Nasdaq: VNLS) todayannounced that Endo has submitted to the U.S. Food and Drug Administration (FDA)a supplemental New Drug Application (sNDA) for Frova(R) (frovatriptan succinate)2.5 mg tablets for the short-term (six days per month) prevention of menstrualmigraine (MM). This submission contains data from previously reported pivotalPhase III studies that met their primary efficacy endpoints of reduction inincidence in MM. If the sNDA is approved by the FDA, Frova(R) will be the only triptan indicatedin the U.S. for the prevention of MM. Currently, Frova(R) is FDA-approved forthe acute treatment of migraine attacks with or without aura in adults where aclear diagnosis of migraine has been established. Approximately 21 million American women suffer from migraines. Of these femalemigraineurs, approximately 60 percent, or 12 million women, are estimated tosuffer from menstrual migraines, a condition which can have a serious anddebilitating impact. Compared to non-menstrual migraines, menstrual migrainescan be more severe and are reported to be longer in duration, often lasting upto three days. "Doctors and patients need to understand that menstrual migraine differs from other kinds of migraines. These differences need to be taken into considerationin order for the condition to be treated appropriately," said Stephen Silberstein, M.D., professor of neurology at the Jefferson Medical College of Thomas Jefferson University, director of the Jefferson Headache Center and lead investigator of the initial efficacy study of Frova(R) for the short-term prevention of menstrual migraine. "The predictable nature of menstrual migraine supports the future use of preventative therapy for this disabling condition." "Menstrual migraines disrupt the lives of millions of women, but currently notriptan is approved to prevent them," said Peter A. Lankau, president and chiefexecutive officer of Endo, which markets Frova(R) in the U.S. "If approved,Frova(R) would provide a novel treatment approach to address this unmet medicalneed. We are pleased to be submitting this sNDA for Frova(R) to the FDA and willwork closely with the Agency throughout the review process." Simon Sturge, chief executive officer of Vernalis, stated "The data confirm thepotential of Frova(R) for the prevention of menstrual migraine. Short-termprevention could be a major benefit for women who do not respond well to acutetreatment. We continue to be impressed by the therapeutic potential of Frova(R)." 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) is notintended for the prophylactic therapy of migraine or for use in the managementof hemiplegic or basilar migraine. The safety and effectiveness of Frova(R) havenot been established for cluster headache, which is present in an older,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 come back more often. Patients with MM may suffer from migraines at anytime, although their migraine is frequently linked to their menstrual cycle.Over 60 percent of migraines in women are associated with menstruation. About EndoEndo Pharmaceuticals Holdings Inc. is a fully integrated specialtypharmaceutical company with market leadership in pain management products.Through its Endo Pharmaceuticals Inc. subsidiary, the company researches,develops, produces and markets a broad product offering of both branded andgeneric pharmaceuticals, meeting the needs of healthcare professionals andconsumers alike. More information, including this and past press releases ofEndo Pharmaceuticals Holdings Inc., is available online at www.endo.com. About VernalisVernalis 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, propelling 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. -- ends -- Enquiries: Endo Pharmaceuticals Inc. +1-610-558-9800Bill Newbould, Vice President, Corporate Communications Vernalis plc +44 (0) 118 977 3133Simon Sturge, Chief Executive OfficerJohn Hutchison, Development DirectorJulia Wilson, Head of Corporate Communication GCI Group +1-212-537-8297Katie Hogan Brunswick Group +44 (0) 20 7404 5959Jon ColesJustine McIlroy Endo Forward-Looking Statement This press release contains forward-looking statements, within the meaning ofSection 27A of the Securities Act of 1933 and Section 21E of the SecuritiesExchange Act of 1934, as amended, that are based on management's beliefs andassumptions, current expectations, estimates and projections. Statements thatare not historical facts, including statements which are preceded by, followedby, or that include, the words "believes," "anticipates," "plans," "expects" orsimilar expressions and statements are forward-looking statements. Endo'sestimated or anticipated future results, product performance or other non-historical facts are forward-looking and reflect Endo's current perspective onexisting trends and information. Many of the factors that will determine theCompany's future results are beyond the ability of the Company to control orpredict. These statements are subject to risks and uncertainties and, therefore,actual results may differ materially from those expressed or implied by theseforward-looking statements. The reader should not rely on any forward-lookingstatement. The Company undertakes no obligation to update any forward-lookingstatements whether as a result of new information, future events or otherwise.Several important factors, in addition to the specific factors discussed inconnection with these forward-looking statements individually, could affect thefuture results of Endo and could cause those results to differ materially fromthose expressed in the forward-looking statements contained in this pressrelease. Important factors that may affect future results include, but are notlimited to: market acceptance of the Company's products and the impact ofcompetitive products and pricing; dependence on sole source suppliers; thesuccess of the Company's product development activities and the timeliness withwhich regulatory authorizations and product launches may be achieved; successfulcompliance with extensive, costly, complex and evolving governmental regulationsand restrictions; the availability on commercially reasonable terms of rawmaterials and other third party manufactured products; exposure to productliability and other lawsuits and contingencies; dependence on third partysuppliers, distributors and collaboration partners; the ability to timely andcost effectively integrate acquisitions; uncertainty associated with pre-clinical studies and clinical trials and regulatory approval; uncertainty ofmarket acceptance of new products; the difficulty of predicting FDA approvals;risks with respect to technology and product development; the effect ofcompeting products and prices; uncertainties regarding intellectual propertyprotection; uncertainties as to the outcome of litigation; changes in operatingresults; impact of competitive products and pricing; product development;changes in laws and regulations; customer demand; possible future litigation;availability of future financing and reimbursement policies of government andprivate health insurers and others; and other risks and uncertainties detailedin Endo's filings with the Securities and Exchange Commission, including itsRegistration Statement on Form S-3 filed with the SEC on March 21, 2006. Readersshould evaluate any statement in light of these important factors. 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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