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Biogen Idec and Vernalis Plc Announce the Start of Phase II Program of BIIB014 in Parkinson's Disease

08 May 2007

 

Cambridge, MA and WINNERSH, U.K., May 8, 2007– Biogen Idec (NASDAQ: BIIB) and Vernalis plc (LSE: VER, Nasdaq: VNLS) today announced the initiation of the Phase II program of BIIB014 (also known as V2006), an oral compound, for the treatment of Parkinson’s disease.  BIIB014 is an adenosine A2A receptor antagonist that may offer a non-dopaminergic therapy for patients with Parkinson’s disease. 

 

The initial Phase II study is a double-blind, placebo controlled randomised trial of single and repeated doses of BIIB014 in patients with late-stage Parkinson’s disease.  In the trial BIIB014 will be added on to the patients usual L-dopa therapy.  The second Phase II study will be a double-blind, placebo controlled randomised, dose-ranging trial of BIIB014 monotherapy in patients with early-stage Parkinson’s disease.  The primary endpoint of both studies will be to evaluate the safety and tolerability of BIIB014.  Secondary endpoints will include 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’s ongoing commitment to the Parkinson’s community.  Dopamine replacement therapy has been the cornerstone of Parkinson's disease therapy, but there is a real need for a new class of non-dopaminergic agents which may help to restore motor function in Parkinson’s disease patients without inducing the adverse effects that limit the clinical utility of current therapies.”

 

BIIB014 has the potential to be a novel, non-dopaminergic treatment option for people living with Parkinson’s disease.  We are pleased with the advancement of this program, which is part of Biogen Idec’s effort to extend our research and development capabilities beyond multiple sclerosis and into other neurological diseases,” said Alfred Sandrock, MD, PhD, Senior Vice President, Neurology Research and Development, Biogen Idec. 

 

Phase I development of BIIB014 was successfully completed by Vernalis, with Biogen Idec now responsible for conducting and funding future development.  Vernalis received a milestone payment of $3 million at the end of 2006 relating to the start of the Phase II programme and will receive additional milestones and royalties on the successful development and commercialisation of products.  In addition, Vernalis has an option to co-promote products arising out of this collaboration in the U.S. 

 

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Enquiries:

Vernalis Contacts

+44 (0) 118 977 3133

Simon Sturge, Chief Executive Officer

 

John Hutchison, Development Director

 

 

 

Brunswick Group

+44 (0) 20 7404 5959

Jon Coles

 

Justine McIlroy

 

Lazar Partners Ltd

 

Gregory Gin

212-867-1762

 

Biogen Idec Contacts

 

Media – Amy Brockelman, Associate Director, Public Affairs

617-914-6524

Investors – Eric Hoffman, Associate Director, Investor Relations

617-679-2812



 

Notes to Editors

 

About Parkinson’s Disease

It is estimated that between 1-1.5 million people in the U.S. have Parkinson's disease, a condition that results from selective degeneration of an area of the brain called the substantia nigra, which is located towards the base of the brain in the basal ganglia.  Normally these nerve cells release dopamine - a chemical that transmits signals between nerve cells (called a neurotransmitter). This central signalling pathway is essential for the fine control of movement and posture, and breakdown results in the symptoms of Parkinson’s disease namely tremor, rigidity, slow movements and postural instability. Muscle rigidity can become so severe as to result in “freezing” also referred to as “off” episodes, when patients are rendered immobile.  Patients also suffer from problems relating to impaired control of blood pressure (postural hypotension) and gut motility, which can impair the absorption of food and drugs.  The disease is progressive and the signs and symptoms generally worsen over time. However, while Parkinson's disease may eventually be disabling, the disease often progresses gradually and with appropriate treatment many patients have a number of years of productive life after initial diagnosis.

 

About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs.  Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies.  Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis.  For product labeling, press releases and additional information about the company, please visit: http://www.biogenidec.com

 

About Vernalis

Vernalis is a speciality bio-pharmaceutical company focused on products marketed to specialist neurologists. The company has two marketed products, Frova® and Apokyn®, and a development pipeline focused on the treatment of central nervous system (CNS) disorders. The company has eight products in clinical development and collaborations with leading, global pharmaceutical companies including Novartis, Biogen Idec and Serono. Vernalis has established a US commercial operation to promote Apokyn® and co-promote Frova® alongside its North American licensing partner, Endo Pharmaceuticals, progressing the company towards its goal of becoming a sustainable, self-funding, R&D-driven, speciality bio-pharmaceutical company. For further information about Vernalis, please visit: www.vernalis.com

 

 

Forward-Looking Statements

This news release contains forward-looking statements regarding the clinical and therapeutic expectations of the BIIB014 compound. These statements are based on the companies' current beliefs and expectations. They are subject to the risks inherent in drug development, including the risks that the effects of the compounds in larger clinical trials may not be as expected or that there may be safety issues or other problems or delays in clinical trials, unexpected technical or manufacturing hurdles, or intellectual property disputes. Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Success in animal models or early stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful. For more detailed information on the risks and uncertainties associated with the companies' drug development and other activities, see the periodic reports of Biogen Idec Inc. and Vernalis plc filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

 

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