Biogen Idec and Vernalis Plc Announce the Start of Phase II Program of BIIB014 in 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.
"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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