UCB returns global rights to tozadenant to Biotie | UCB
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UCB returns global rights to tozadenant to Biotie

  • Portfolio decision by UCB in light of its pipeline priorities
  • Biotie will continue to develop tozadenant in Parkinson’s disease

Brussels, Belgium 21 March, 7am CET regulated information: UCB will return the global rights to tozadenant (SYN115), a selective inhibitor of the adenosine 2a (A2a) receptor for treatment of Parkinson’s disease, to Biotie Therapies Corp. Tozadenant is scheduled to start the phase 3 development program in 2015. This decision 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 tozadenant.

“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.”

“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,” said Timo Veromaa, President and CEO of Biotie.

The companies are working together to execute an appropriate transfer of the program. The scheduled End-of-Phase 2 meeting with US Food and Drug Administration will take place as planned in the first half of 2014.

In 2013, following positive results from the phase 2b study, UCB licensed worldwide exclusive rights to Biotie's tozadenant. The Phase 3 program is scheduled to start early 2015. Biotie was to conduct phase 3 development of tozadenant in return for milestone payments from UCB. This decision today will lead to a non-recurring, one-time write-off of UCB’s intangible assets and other related programs and costs of approx. € 40 million. This does not impact UCB’s financial guidance for 2014.

For further information

  • Antje Witte, Investor Relations, UCB
    T +32.2.559.9414, antje.witte@ucb.com
  • Alexandra Deschner, Investor Relations, UCB
    T: +32.2.559.9683, alexandra.deschner@ucb.com
  • France Nivelle, Global Communications, UCB
    T +32.2.559.9178, France.nivelle@ucb.com
  • Laurent Schots, Media Relations, UCB
    T +32.2.559.9264, laurent.schots@ucb.com

About UCB

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 8500 people in approximately 40 countries, the company generated revenue of € 3.4 billion in 2013. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

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.

ABOUT BIOTIE (www.biotie.com)

Biotie (www.biotie.com) is a specialized drug development company focused on products for neurodegenerative and psychiatric disorders. For the past years, Biotie has successfully operated a strategy built around search, profile and partner. This has delivered Selincro (nalmefene) for alcohol dependency, which received European marketing authorization in February 2013 and is currently being rolled out across Europe by partner H. Lundbeck A/S, and tozadenant, a novel A2a antagonist which is transitioning into Phase 3 development for Parkinson's disease and for which Biotie will hold exclusive, global rights. Biotie is actively developing its pipeline assets, including SYN120, a unique potent 5-HT6/5-HT2a dual antagonist for which a Phase 2 study in Alzheimer’s diseases is expected to commence recruitment by the end of 2014; nepicastat, a selective inhibitor of dopamine beta hydroxylase which is currently in a Phase 2 study, fully funded by NIDA, for treatment seeking cocaine addicts and for which topline data is expected in the first half of 2015; and BTT-1023, a monoclonal antibody targeting Vascular Adhesion Protein 1 for which a Phase 2 study in primary sclerosing cholangitis, a rare fibrotic disease of the liver, is expected to start recruiting by the end of 2014. Biotie's shares are listed on NASDAQ OMX Helsinki.

Forward looking statements

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There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed.

Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.

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