8th Apr 2008 07:05
Vernalis PLC08 April 2008 8 April 2008 Vernalis plc: Endo Provides Update on Frova(R) sNDA Vernalis plc (LSE: VER) today announces that Endo Pharmaceuticals Inc. hasnotified the US Food and Drug Administration (FDA) of the withdrawal of thesupplemental new drug application (sNDA) without prejudice to refiling asafforded under 21 CFR 314.65 for Frova(R) (frovatriptan succinate) 2.5 mgtablets. This sNDA was for the additional indication of Frova(R) for theshort-term (six days per month) prevention of menstrual migraine. Vernalis andEndo are continuing to evaluate the potential for Frova(R) for this indicationand other related indications. In its business restructuring, announced on 20February 2008, Vernalis based its strategy on the assumption that, for theimmediate future, Frova(R) would only be approved for the acute treatment ofmigraine. -- ends -- Enquiries: Vernalis plc +44 (0) 118 977 3133 Tony Weir, CFO Brunswick Group +44 (0) 20 7404 5959 Jon Coles Justine McIlroy Alex Tweed Notes to Editors 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 six products in clinical development andcollaborations with leading, global pharmaceutical companies including Novartis,Biogen Idec, Endo, Menarini and Chiesi: Product Indication Phase I Phase II Phase III Market Marketing Rights Apokyn (R) Parkinson's Disease X North America Frova (R) Migraine X Menarini, Endo (royalties) Frova (R) Menstrual Migraine X Menarini, Endo (royalties) Prevention V1512 Parkinson's Disease X World Wide (excl. Italy) V10153 Thrombotic Disorders X World Wide V3381 Neuropathic Pain X World Wide V2006 Parkinson's Disease X Biogen Idec (royalty) V24343 Obesity X World Wide AUY922 Cancer X Novartis (royalty) For further information about Vernalis, please visit www.vernalis.com 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, 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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