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news.Belgium-based biopharmaceutical firm UCB Pharma (UCB) will return global rights of tozadenant (SYN115), a selective inhibitor of the adenosine 2a (A2a) receptor intended for the treatment of Parkinson’s disease, to Finland-based Biotie Therapies.
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The decision to return the rights of tozadenant has been made on the assessment of UCB’s early and late stage clinical development pipeline as well as its preclinical opportunities and does not reflect any concerns regarding safety or efficacy of the drug.
Tozadenant has delivered clinically relevant and statistically highly significant effects in Parkinson’s disease, across multiple pre-specified evaluation parameters, in a 420 patient Phase IIb trial completed in December 2012.
Patient enrollment for the Phase III program of tozadenant is scheduled to start in the first half of 2015.
Biotie president and CEO Timo Veromaa said the company respects 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," Veromaa said.
"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."
UCB CMO Iris Loew-Friedrich said, "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 said 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 II meeting with US Food and Drug Administration (FDA) in the first half of 2014.
Both the firms are working together to execute an appropriate transfer of the program back to Biotie.
Biotie had originally licensed tozadenant to UCB Pharma in 2010 and UCB paid $20m to exercise its license in February 2013.