Date: 2014-08-28
Type of information: Licensing agreement
Compound: tozadenant (SYN115)
Company: UCB (Belgium) Biotie Therapies (Finland)
Therapeutic area: Neurodegenerative diseases - CNS diseases
Type agreement: licensing
Action mechanism: SYN115 is an orally bioavailable potent and selective adenosine A2a receptor antagonist. Adenosine A2a inhibition has been shown in preclinical studies to reverse motor deficits and enhance the effect of current PD therapies, e.g. levodopa and dopamine agonists, without inducing troublesome dyskinesia (involuntary movements). In addition, SYN115 also displays activity in preclinical models on non-motor symptoms of PD including depression, cognition and anxiety.
Disease: Parkinson's disease
Details: * On February 26, 2013, UCB has licensed worldwide exclusive rights to Biotie's tozadenant (SYN115), a selective inhibitor of the adenosine 2a receptor, currently in development for the treatment of Parkinson’s disease. As a result, Biotie will receive a one-time fee payment of $ 20 million from UCB. In addition, the parties have amended their original licence agreement, such that Biotie will now conduct phase 3 development of tozadenant in return for additional payments from UCB relating to defined development, regulatory and commercialization milestones.
The decision to in-license tozadenant follows positive top-line results of the phase 2b study. These resultats have been reported last December and Biotie Therapies intends to present them at upcoming medical conferences and scientific publications. Patient enrolment in the phase 3 program is currently planned to commence by the end of 2014. UCB and Biotie will collaborate on the on-going clinical development and UCB will be responsible for the manufacture and commercialization of tozadenant.
Financial terms: The original agreement between UCB and Biotie was announced in 2010. Under the terms of the original agreement UCB will make an immediate one-time payment of $20 million to Biotie and Biotie will remain eligible to a potential additional $340 million in future milestone payments. Under the revised agreement, Biotie will be eligible for additional payments in the low triple digit millions in total over the next six years based on the successful completion of defined development, regulatory and commercialization milestones. Further financial details of the agreement are not disclosed.
Latest news: * On August 28, 2014, Biotie Therapies announced that, following the announcement on 21 March 2014 that Biotie was to regain global rights to tozadenant from UCB Pharma, the companies have now formally agreed the details of the transfer.This transfer agreement confirms that UCB will meet all its contractual and scientific commitments regarding the ongoing development program for tozadenant, which are expected to be fully completed by the end of 2014. As part of this transfer agreement, UCB will make a contribution to a portion of the short term development costs related to the termination, which it will be able to recover from any future revenues generated from tozadenant by Biotie. 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 2b study completed in December 2012. It is expected that the Phase 3 study will be able to start recruiting patients during H1 2015, as planned. As part of this agreement, UCB has agreed to certain restrictions on its current shareholding in Biotie into the next year.
