Formal Transfer Of Global Rights For Tozadenant To BioTie Therapies Corp. Concluded
8/28/2014 10:16:18 AM
Biotie Therapies Corp. ("Biotie") announces that, following the announcement on 21 March 2014 that Biotie was to regain global rights to tozadenant from UCB Pharma S.A. (UCB), the companies have now formally agreed the details of the transfer.
Transfer activities have progressed well to date. 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 (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. It is expected that the Phase 3 study will be able to start recruiting patients during H1 2015, as planned.
Timo Veromaa, President and CEO of Biotie commented "We are pleased to have reached this formal agreement with UCB for the transfer of tozadenant back to Biotie. We appreciate UCB's significant investment and commitment to the tozadenant program to-date and 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 has now been published in Lancet Neurology. We have concluded that the best development strategy to maximize tozadenant's value to our shareholders is to continue with the Phase 3 study within our own portfolio. We are currently evaluating various options, which may include a capital increase, to support the clinical studies and a strong regulatory filing package for tozadenant."
As part of this agreement, UCB has agreed to certain restrictions on its current shareholding in Biotie into the next year.
Turku, 28 August 2014
Biotie Therapies Corp.
President and CEO
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Virve Nurmi, Investor Relations Manager
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Tozadenant is an oral, potent and selective adenosine A2a receptor antagonist being developed for the treatment of Parkinson's disease. Tozadenant has displayed clinically relevant and statistically highly significant effects in Parkinson's disease, across multiple pre-specified evaluation metrics, in a 420 patient Phase 2b study completed in December 2012, and it is currently transitioning into Phase 3 development.
The preparations for the tozadenant Phase 3 program in Parkinson's disease have progressed well. These activities include CMC and non-clinical work, and certain Phase 3 enabling clinical pharmacology studies.
Biotie is a specialized drug development company focused on products for neurodegenerative and psychiatric disorders. Biotie's development has delivered Selincro (nalmefene) for alcohol dependence, which received European marketing authorization in 2013 and is currently being rolled out across Europe by partner Lundbeck. The current development products include tozadenant for Parkinson's disease, which is transitioning into Phase 3 development, and three additional compounds which are in Phase 2 development for cognitive disorders including Parkinson's disease dementia, cocaine dependence, and primary sclerosing cholangitis (PSC), a rare fibrotic disease of the liver.
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