Vernalis PLC Regulatory News (VER)

10 Sep 2007 12:00

Vernalis PLC10 September 2007 For Immediate Release FDA INFORMS ENDO AND VERNALIS THAT NEW TARGET ACTION DATE ON FROVA(R) sNDA IS SEPT. 30, 2007 CHADDS FORD, Pa., and WINNERISH, U.K., Sep. 10, 2007 -- Endo PharmaceuticalsInc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (Nasdaq:ENDP), and Vernalis plc (LSE: Ver) today announced that the U.S. Food and DrugAdministration has informed the companies that it is now targeting September 30,2007 as the date for issuing an action letter for the supplemental New DrugApplication for FROVA(R) (frovatriptan succinate) 2.5 mg tablets. As previouslydisclosed, the FDA requested an extension of the August 19, 2007 review date tohave more time to review the sNDA for the additional indication as short-term(six days) prevention of menstrual migraine. Also as previously noted, Endo and Vernalis intend to continue with theirexisting commercial plan, which includes commercial launch in January 2008 ifthe sNDA is approved. About Endo Endo 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. Endo Forward-Looking Statements 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; a determination by aregulatory agency that we are engaging in inappropriate sales or marketingactivities, including promoting the "off-label" use of our products; changes inoperating results; impact of competitive products and pricing; productdevelopment; changes in laws and regulations; customer demand; possible futurelitigation; availability of future financing and reimbursement policies ofgovernment and private health insurers and others; and other risks anduncertainties detailed in Endo's filings with the Securities and ExchangeCommission, including its Annual Report on Form 10-K filed with the SEC on March1, 2007. Readers should evaluate any statement in light of these importantfactors. 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 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. CONTACTS: Endo Pharmaceuticals Inc. +1-610-558-9800Bill Newbould, Vice President,Corporate Communications Vernalis plc +44 (0) 118 977 3133Simon Sturge, Chief Executive OfficerTony Weir, Chief Financial Officer Brunswick Group +44 (0) 20 7404 5959Jon ColesJustine McIlroyAlex Tweed This information is provided by RNS The company news service from the London Stock Exchange