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Tozadenant is transitioning into Phase 3 development for Parkinson's disease
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Biotie to host a conference call for analysts and media today at 14:00 Central European time
Turku, Finland, March 21, 2014. Biotie Therapies Corp. announced today that UCB Pharma S.A. (UCB) will return global rights to tozadenant to Biotie. Tozadenant (SYN115), a selective inhibitor of the adenosine 2a (A2a) receptor, has delivered clinically relevant and statistically highly significant effects in Parkinson's disease, across multiple pre-specified evaluation parameters, in a 420 patient Phase 2b study completed in December 2012. Tozadenant is expected to start recruitment for the Phase 3 program in H1 2015.
Biotie regaining the rights follows after UCB's assessment of its early and late stage clinical development pipeline as well as its preclinical opportunities and does not reflect any concerns regarding safety or efficacy of tozadenant.
"We respect UCB's portfolio based decision, and appreciate its significant investment and commitment to the tozadenant program to-date. Owning full global rights to tozadenant will enable Biotie to evaluate the most suitable development strategy for this Phase 3 ready asset to maximize its value to our shareholders. As part of this evaluation we will consider other partners to assist us in the development and commercialization of this novel compound. We remain convinced that tozadenant will provide significant and clinically meaningful benefits to Parkinson's patients based on the robust and positive Phase 2b data, that we have already reported", says Timo Veromaa, President and CEO of Biotie.
"At UCB, we have a very rich portfolio of research and development programs and continuously review and prioritize within the portfolio", says Prof. Dr. Iris Loew-Friedrich, CMO of UCB. "We will continue working with Biotie to make tozadenant phase 3 ready and to ensure a smooth transition of the program back to Biotie."
UCB has confirmed that it will meet all its contractual and scientific commitments regarding the ongoing development program for tozadenant, including conducting together with Biotie the scheduled End-of-Phase 2 meeting with US Food and Drug Administration in H1 2014. The companies are working together to execute an appropriate transfer of the program back to Biotie.
Tozadenant was originally licensed to UCB in 2010 and UCB paid Biotie $20 million to exercise its license in February 2013.
Biotie expects to be able to give further guidance on any potential change in development timelines during Q2 2014.