Vernalis PLC Regulatory News (VER)

8 May 2007 07:01

Vernalis PLC08 May 2007 May 8, 2007 Biogen Idec and Vernalis Plc Announce the Start of Phase II Program of BIIB014 in Parkinson's Disease Cambridge, MA and WINNERSH, U.K., May 8, 2007- Biogen Idec (NASDAQ: BIIB) andVernalis plc (LSE: VER, Nasdaq: VNLS) today announced the initiation of thePhase II program of BIIB014 (also known as V2006), an oral compound, for thetreatment of Parkinson's disease. BIIB014 is an adenosine A2A receptorantagonist that may offer a non-dopaminergic therapy for patients withParkinson's disease. The initial Phase II study is a double-blind, placebo controlled randomisedtrial of single and repeated doses of BIIB014 in patients with late-stageParkinson's disease. In the trial BIIB014 will be added on to the patients usualL-dopa therapy. The second Phase II study will be a double-blind, placebocontrolled randomised, dose-ranging trial of BIIB014 monotherapy in patientswith early-stage Parkinson's disease. The primary endpoint of both studies willbe to evaluate the safety and tolerability of BIIB014. Secondary endpoints willinclude the evaluation of motor function. Simon Sturge, CEO of Vernalis commented: "The progress into Phase II trials is of particular significance to Vernalis'growing Parkinson's disease franchise and further demonstrates the company'songoing commitment to the Parkinson's community. Dopamine replacement therapyhas been the cornerstone of Parkinson's disease therapy, but there is a realneed for a new class of non-dopaminergic agents which may help to restore motorfunction in Parkinson's disease patients without inducing the adverse effectsthat limit the clinical utility of current therapies." "BIIB014 has the potential to be a novel, non-dopaminergic treatment option forpeople living with Parkinson's disease. We are pleased with the advancement ofthis program, which is part of Biogen Idec's effort to extend our research anddevelopment capabilities beyond multiple sclerosis and into other neurologicaldiseases," said Alfred Sandrock, MD, PhD, Senior Vice President, NeurologyResearch and Development, Biogen Idec. Phase I development of BIIB014 was successfully completed by Vernalis, withBiogen Idec now responsible for conducting and funding future development.Vernalis received a milestone payment of $3 million at the end of 2006 relatingto the start of the Phase II programme and will receive additional milestonesand royalties on the successful development and commercialisation of products.In addition, Vernalis has an option to co-promote products arising out of thiscollaboration in the U.S. -- ends -- Enquiries:Vernalis Contacts +44 (0) 118 977 3133Simon Sturge, Chief Executive OfficerJohn Hutchison, Development Director Brunswick Group +44 (0) 20 7404 5959Jon ColesJustine McIlroyLazar Partners LtdGregory Gin 212-867-1762 Biogen Idec ContactsMedia - Amy Brockelman, Associate Director, Public Affairs 617-914-6524Investors - Eric Hoffman, Associate Director, Investor 617-679-2812Relations Notes to Editors About Parkinson's Disease It is estimated that between 1-1.5 million people in the U.S. have Parkinson'sdisease, a condition that results from selective degeneration of an area of thebrain called the substantia nigra, which is located towards the base of thebrain in the basal ganglia. Normally these nerve cells release dopamine - achemical that transmits signals between nerve cells (called a neurotransmitter).This central signalling pathway is essential for the fine control of movementand posture, and breakdown results in the symptoms of Parkinson's disease namelytremor, rigidity, slow movements and postural instability. Muscle rigidity canbecome so severe as to result in "freezing" also referred to as "off" episodes,when patients are rendered immobile. Patients also suffer from problems relatingto impaired control of blood pressure (postural hypotension) and gut motility,which can impair the absorption of food and drugs. The disease is progressiveand the signs and symptoms generally worsen over time. However, whileParkinson's disease may eventually be disabling, the disease often progressesgradually and with appropriate treatment many patients have a number of years ofproductive life after initial diagnosis. About Biogen Idec Biogen Idec creates new standards of care in therapeutic areas with high unmetmedical needs. Founded in 1978, Biogen Idec is a global leader in thediscovery, development, manufacturing, and commercialization of innovativetherapies. Patients in more than 90 countries benefit from Biogen Idec'ssignificant products that address diseases such as lymphoma, multiple sclerosis,and rheumatoid arthritis. For product labeling, press releases and additionalinformation about the company, please visit: http://www.biogenidec.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 the treatment of centralnervous system (CNS) disorders. The company has eight products in clinicaldevelopment and collaborations with leading, global pharmaceutical companiesincluding Novartis, Biogen Idec and Serono. Vernalis has established a UScommercial operation to promote Apokyn(R) and co-promote Frova(R) alongside itsNorth American 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 Forward-Looking Statements This news release contains forward-looking statements regarding the clinical andtherapeutic expectations of the BIIB014 compound. These statements are based onthe companies' current beliefs and expectations. They are subject to the risksinherent in drug development, including the risks that the effects of thecompounds in larger clinical trials may not be as expected or that there may besafety issues or other problems or delays in clinical trials, unexpectedtechnical or manufacturing hurdles, or intellectual property disputes. Drugdevelopment involves a high degree of risk. Only a small number of research anddevelopment programs result in the commercialization of a product. Success inanimal models or early stage clinical trials does not ensure that later stage orlarger scale clinical trials will be successful. For more detailed informationon the risks and uncertainties associated with the companies' drug developmentand other activities, see the periodic reports of Biogen Idec Inc. and Vernalisplc filed with the Securities and Exchange Commission. The companies assume noobligation to update any forward-looking statements, whether as a result of newinformation, future events or otherwise. This information is provided by RNS The company news service from the London Stock Exchange