Amendment to the Release on UCB License of Worldwide Rights to Tozadenant in
Parkinson's Disease From Biotie
Biotie Therapies Corp. Stock Exchange Release 27 February 2013 at
TURKU, FINLAND -- (Marketwire) -- 02/27/13 -- 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
-- Novel product in development for the treatment of people living with
-- 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(R) 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
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.
President and CEO
For further information, please contact:
Virve Nurmi, Investor
tel. +358 2 274 8911, e-mail:
NASDAQ OMX Helsinki Ltd
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(TM) (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(TM) 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
For further information, please contact:
Investor Relations Manager
tel. +358 2 274 8911
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