TURKU, FINLAND--(Marketwire - February 27, 2013) - With reference to the stock exchange release on 26 February 2013 at 7:00 p.m. Biotie clarifies that the additional milestones under the revised agreement and Biotie being responsible for conducting phase 3 development of tozadenant are not likely to have significant impact on profitability of Biotie during the duration of the clinical development. The amended release in its entirety may be found below.
UCB to license worldwide rights to tozadenant in Parkinson's disease from Biotie
- Novel product in development for the treatment of people living with Parkinson's disease
- Biotie receives USD 20 million license fee payment
- Original agreement modified: Biotie to conduct phase 3 development
Biotie and UCB announced today that 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 USD 20 million from UCB. In addition, the parties have amended their original license 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.
"UCB is committed to improving the lives of people with Parkinson's disease and currently provides Neupro® a transdermal dopamine agonist for the symptomatic treatment of all stages of idiopathic Parkinson's disease," said Professor Dr Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President UCB. "Biotie is a valuable partner and the decision to in-license follows the positive top-line results of the phase 2b study. We were impressed by the performance of Biotie and decided that they are the ideal party to continue to spearhead the development of tozadenant. We look forward to collaborating with Biotie in the on-going clinical development. With the addition of the novel compound tozadenant to UCB's development portfolio we should be able to further contribute to the advancement of the treatment and care for people living with Parkinson's disease."
The phase 2b study was a double-blind, randomized, placebo-controlled study evaluating the safety and efficacy of tozadenant as adjunctive therapy in levodopa-treated Parkinson's patients with end of dose wearing off. Results from the phase 2b study are expected to be presented at upcoming medical conferences and in scientific publications. Patient enrollment in the phase 3 program is currently planned to commence by the first half of 2015.
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 USD 20 million to Biotie and Biotie will remain eligible to a potential additional USD 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. The final amounts of the additional payments are to be determined between the parties upon completion of the study plans in the coming months. The additional milestone payments are likely not to significantly impact Biotie's profitability during the duration of the clinical development. UCB and Biotie will collaborate on the on-going clinical development and UCB will be responsible for the manufacture and commercialization of tozadenant.
"We are thrilled with the opportunity to continue the development of tozadenant in partnership with UCB", said Timo Veromaa, President and Chief Executive Officer of Biotie. "We are encouraged by the vote of confidence provided to us by UCB to continue with us the development of tozadenant and the very significant incremental financial resources that we will be given to complete the clinical work."
Turku, 27 February 2013
Biotie Therapies Corp.
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About Parkinson's disease
Parkinson's disease is a chronic, degenerative neurological disease. It is commonly associated with movement (motor) symptoms such as tremors (uncontrollable shaking), rigidity (stiffness or muscle tensing) and bradykinesia (slowness and loss of spontaneous movement), but also commonly causes underlying symptoms such as mood and cognitive impairment, pain, depression and fatigue.
About tozadenant (SYN115)
Tozadenant is an orally administered, selective inhibitor of the adenosine 2a (A2a) receptor being developed initially for the treatment of Parkinson's disease. A2a receptors are expressed in high concentration in the striatum of the brain and are thought to play an important role in regulating motor function. Tozadenant blocks the effect of endogenous adenosine at the A2a receptors, resulting in the potentiation of the effect of dopamine and inhibition of the effect of glutamate at the mGluR5 receptor.
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8 500 people in about 40 countries, the company generated revenue of EUR 3.2 billion in 2011. UCB is listed on Euronext Brussels (symbol: UCB).
About Biotie (www.biotie.com)
Biotie is a specialized drug development company focused on the development of drugs for neurodegenerative and psychiatric disorders (e.g. Parkinson's disease, Alzheimer's disease and other cognitive disorders, alcohol and drug dependence (addiction) and post-traumatic stress disorder), and inflammatory and fibrotic liver disease. The company has a strong and balanced development portfolio with several innovative small molecule and biological drug candidates at different stages of clinical development. Biotie's products address diseases with high unmet medical need and significant market potential.
Biotie's most advanced product, Selincro™ (nalmefene), licensed to Lundbeck A/S, has on 14 December 2012 received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending marketing authorization of Selincro™ for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high level of alcohol consumption. In addition, Biotie has a strategic collaboration with UCB Pharma S.A. covering tozadenant which has successfully completed a Phase 2b study in 420 patients with advanced Parkinson's disease. Biotie shares are listed on NASDAQ OMX Helsinki Ltd. Symbol: BTH1V