3rd Aug 2006 07:00
Vernalis PLC03 August 2006 3 August 2006 Vernalis Starts Phase IIa Trial of V3381 in Diabetic Neuropathic Pain Vernalis plc (LSE: VER, Nasdaq: VNLS) today announced that it has commencedenrolment into a Phase IIa trial of V3381 in patients with neuropathic painresulting from long-standing diabetes. V3381 is the Company's novel drugcandidate that is believed to have dual mechanisms of action targeting both thecentral and peripheral nervous systems and is a programme where Vernalis hasworld-wide rights. The randomised, double-blind, crossover Phase IIa study is designed to assesssafety, pharmacokinetics and preliminary efficacy of repeat dosing of V3381,with efficacy being assessed on a numerical point pain rating scale recordedusing daily diaries. The trial is being conducted in the United States andCanada, will include approximately 30 patients and is planned to complete in 12months. V3381 was originally licensed from Chiesi and has previously undergoneevaluation in pre-clinical and Phase I clinical studies, including two proof-of-concept studies in a human model of neuropathic pain. "Neuropathic pain causes enormous suffering and we are hopeful that V3381 mayultimately prove to be an effective treatment for this challenging condition,"said Simon Sturge, CEO of Vernalis. "We are building our franchise in painmanagement and are pleased that we have progressed V3381 to the next stage inits development." Neuropathic pain resulting from diabetes is a poorly treated condition thataffects 4 million patients in the US and Europe. According to the NationalInstitute of Diabetes & Digestive & Kidney Diseases, approximately half of thosewith diabetes develop some form of neuropathy, highlighting the growing need fordrug treatment in this condition. The global trends towards obesity arefurthering the incidence of diabetes and hence the problem of neuropathic painis on the increase. -- ends -- Enquiries: Vernalis plc +44 (0) 118 977 3133 Simon Sturge, Chief Executive OfficerJohn Hutchison, Development DirectorJulia Wilson, Head of Corporate Communication Brunswick Group +44 (0) 20 7404 5959Jon Coles / Alex Tweed Notes to EditorsNeuropathic pain is a chronic form of pain related to damage to nerves and theirsignalling processes, and unlike other forms of pain, is generallynon-responsive to current analgesics, does not diminish over time and canincrease in both intensity and area. This type of pain occurs in later stages ofdiabetes, post-herpetic neuralgia (shingles), side effects of chemotherapy,trigeminal (facial) neuralgia, HIV infection, spinal cord injuries and othernerve injuries (eg. amputation). 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: Product Indication Phase Phase Phase Registration Market Marketing I II III Rights Apokyn(R) Parkinson's x North Disease America Frova(R) Migraine x US Co-promotion Endo (EU - royalties) Frova(R) Menstrual x US Migraine Co-promotion Prevention Endo (EU - royalties) V1512 Parkinson's x World Wide Disease (excl. Italy) V10153 Thrombotic x World Wide Disorders V1003 Acute Pain x US Profit share Option Reckitt Benckiser V3381 Neuropathic x World Wide Pain V2006 Parkinson's x US Disease Co-promotion Biogen Idec MMPI Multiple x None - Sclerosis royalty (Serono) Vernalis has established a US commercial operation to promote Apokyn(R) andco-promote Frova(R) alongside its North American licensing partner, EndoPharmaceuticals, propelling the company towards its goal of becoming asustainable, self-funding, R&D-driven, speciality bio-pharmaceutical company.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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