Biotie Therapies Corp. Stock Exchange Release 24 September 2013 at
9.00 a.m
Biotie Completes Planned Portfolio Review
Biotie Therapies Corp., a specialized drug development company focused on
neurodegenerative and psychiatric disorders, today announces the outcome of its
planned portfolio review following its success earlier in the year with the
approval and launch of Selincro® in Europe by H. Lundbeck A/S ("Lundbeck") and
the exercise by UCB S.A. ("UCB") of its license for tozadenant (SYN115), for
which Biotie received a USD 20 million milestone.
The review establishes the best way for Biotie to maximize value from its
current products and introduces a new strategy under which the company will use
its relatively strong financial position to seek additional pipeline
opportunities, including those that it could potentially develop itself through
to regulatory approval and beyond.
For the past few years, Biotie has successfully operated a strategy built around
search, profile and partner to bring novel products to market. This strategy has
to date delivered development and commercialization deals for:
* Selincro®, used to treat alcohol dependence, with Lundbeck, which introduced
the product in Europe earlier in 2013. Biotie is eligible to receive
milestones for launches in further key European markets in 2013 and 2014 and
to receive royalties and further milestone payments; and
* tozadenant (SYN115) for Parkinson's disease, with UCB, which is being
prepared for Phase 3 development. Under the terms of a subsequent agreement
Biotie will conduct the phase 3 development in return for additional
payments from UCB relating to defined development, regulatory and commercial
milestones.
NRL-1, a proprietary intranasal formulation of diazepam that is being developed
to treat patients with epilepsy to manage the bouts of acute and repetitive
seizures they experience, became part of Biotie's development portfolio in June
2013 when the Company signed an exclusive option to acquire Neurelis, Inc., a
private U.S. company developing products for epilepsy and other disorders of the
central nervous system.
The purchase of an option to acquire Neurelis and its lead product NRL-1 has
given Biotie an important new development opportunity. Biotie is now actively
engaged in conducting further manufacturing and pre-clinical work with the
product and expects to exercise the option in the first half of 2014 following
completion of the work and discussions with the FDA.
The treatment of acute and repetitive seizures is an area where there are
currently limited treatment options, particularly for adolescent and adult
patients. Biotie believes that the introduction of NRL-1 in a patient friendly
intra-nasal applicator will give it access to a significant commercial
opportunity in the U.S. that could be accessed via a small, specialist sales
force, which Biotie could potentially establish. The successful development and
commercialization of NRL-1 will allow Biotie to generate enhanced shareholder
value and, as a result of the portfolio review, further opportunities of this
kind will now be sought.
The portfolio review has also led to the decision to conduct a Phase 2 proof of
concept study for primary sclerosing cholangitis, a rare fibrotic disease of the
liver affecting young adults, with BTT-1023. The Company is in advanced
discussions for non-dilutive co-funding for the study.
Discussions for a potential partnership for SYN120, which is being developed for
the treatment of Alzheimer's disease and other cognitive disorders, are at an
advanced stage.
The trial for nepicastat (SYN117), in the treatment of cocaine dependency, which
began in May 2013 and is being funded by the U.S. National Institute of Drug
Abuse, is continuing to recruit, with results being expected in approximately
two years.
Timo Veromaa, Biotie's President and CEO commented, "As a result of a detailed
portfolio review we now have a clear strategy for each of our current products
that we believe will allow us to enhance shareholder value. We will also utilize
our relatively strong financial position to identify new assets that will
further strengthen our portfolio and that we could potentially develop all the
way to the market."
Turku, 24 September 2013
Biotie Therapies Corp.
Timo Veromaa
President and CEO
For further information, please contact:
Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8911
e-mail: virve.nurmi@biotie.com
DISTRIBUTION
NASDAQ OMX Helsinki Ltd
Main Media
www.biotie.com
About Biotie
Biotie is a specialized drug development company focused primarily 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 in collaboration with UCB Pharma S.A.. Biotie also has exclusive rights
through an option to acquire Neurelis Inc., which includes NRL-1, an intranasal
formulation of diazepam for epileptic seizure management. Biotie plans to seek
further opportunities of this kind to generate a strong portfolio of products.
Biotie's shares are listed on NASDAQ OMX Helsinki.
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