Biotie Therapies Oyj: Biotie Completes Planned Portfolio Review
Biotie Therapies Corp. Stock Exchange Release 24 September 2013 at
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 ofa 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.
President and CEO
For further information, please contact:
Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8911
NASDAQ OMX Helsinki Ltd
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.
This announcement is distributed by Thomson Reuters on behalf of Thomson
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information contained therein.
Source: Biotie Therapies Oyj via Thomson Reuters ONE
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