16th Mar 2007 11:44
Vernalis PLC16 March 2007 News Release For Immediate Release March 16, 2007 ENDO AND VERNALIS PLC ANNOUNCE THREE-MONTH EXTENSION OF PDUFA DATE FOR FROVA(R) SNDA CHADDS FORD, Pa., and WINNERSH, U.K., March 16, 2007 - Endo PharmaceuticalsHoldings Inc. (Nasdaq: ENDP) and Vernalis plc (LSE: VER, Nasdaq: VNLS) todayannounced that the U.S. Food and Drug Administration (FDA) has informed thecompanies that it will require an additional three months to review Endo'spreviously submitted Supplemental New Drug Application (sNDA) for Frova(R)(frovatriptan succinate) 2.5 mg tablets for the expanded indication ofshort-term prevention of menstrual migraine (MM). The agency now anticipatescompleting its review of this application on or before August 19, 2007. Aspreviously disclosed, the original PDUFA (Prescription Drug User Fee Act) reviewdate was May 19, 2007. The companies noted that the FDA's request relates solely to the presentation ofthe data and not its content and that no additional data have been requested. "We look forward to working with the FDA to expand Frova(R)'s indication andbring this important new prophylactic treatment for menstrual migraine tomarket," said Peter A. Lankau, President and Chief Executive Officer of Edno. Headded that the PDUFA date extension would have no impact on Endo's 2007financial guidance. Contacts:Endo Pharmaceuticals IncBill Newbould (610) 558-9800 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 LtdGregory Gin (212) 867-1762 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 (greater than or equal to 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. About Endo Endo Pharmaceuticals Holdings Inc. is a fully integrated specialtypharmaceutical company with market leadership in pain management products.Through its wholly owned Endo Pharmaceuticals Inc. subsidiary, the companyresearches, develops, produces and markets a broad product offering of bothbranded and generic pharmaceuticals, meeting the needs of healthcareprofessionals and consumers alike. More information, including this and pastpress releases of Endo Pharmaceuticals Holdings Inc., is available online atwww.endo.com. 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 central nervous systemdisorders. The company has eight products in registration/clinical developmentand collaborations with leading, global pharmaceutical companies includingNovartis, Biogen Idec and Serono. Vernalis has established a U.S. commercialoperation to promote Apokyn(R) and co-promote Frova(R) alongside its NorthAmerican licensing partner, Endo Pharmaceuticals, progressing the companytowards its goal of becoming a sustainable, self-funding, R&D-driven, specialitybio-pharmaceutical company. For further information about Vernalis, pleasevisit: www.vernalis.com 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 itsForm 10-K filed with the SEC on March 1, 2007. Readers should evaluate anystatement 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 approval of the Company's products, the Company'sability to find partners for the development and commercialisation of itsproducts, as well as the Company's future capital raising activities.Forward-looking statements involve risks and uncertainties. Actual events coulddiffer materially from those projected herein and depend on a number of factorsincluding the success of the Company's research strategies, the applicability ofthe discoveries made therein, the successful and timely completion of clinicalstudies, the uncertainties related to the regulatory process, the ability of theCompany to identify and agree beneficial terms with suitable partners for thecommercialisation and/or development of its products, as well as the achievementof expected synergies from such transactions, the acceptance of Frova(R) andApokyn(R) and other products by consumers and medical professionals, thesuccessful integration of completed mergers and acquisitions and achievement ofexpected synergies from such transactions, and the ability of the Company toidentify and consummate suitable strategic and business combinationtransactions. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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