Biotie Purchases Option to Acquire Neurelis, Inc.
Opportunity to Develop Late-Stage Product for Treatment of Epileptic
TURKU, FINLAND -- (Marketwired) -- 06/04/13 -- Biotie Therapies
Corp. ("Biotie") today announced that it has obtained an exclusive
option to acquire Neurelis, Inc. ("Neurelis"), a private specialty
pharmaceutical company based in San Diego, CA, focused on developing
products for epilepsy and other disorders of the central nervous
Neurelis' lead product, NRL-1, is a proprietary intranasal
formulation of diazepam delivered via an already marketed nasal
sprayer. It is being developed to help patients with epilepsy who
require intermittent use of diazepam to manage bouts of acute and
Timo Veromaa, President and Chief Executive Officer of Biotie stated
"Our interest in Neurelis is in line with our ongoing portfolio
review, which is focused on ensuring that we are developing products
that address areas of significant unmet medical need and have the
greatest potential for creating value for our shareholders. We are
now in a position to assess the potential of NRL-1 alongside our
internal pipeline opportunities." He continued "NRL-1 is an exciting
late-stage product for the control of epileptic seizures. We believe
the product could offer a far better solution for patients and their
caregivers who currently rely on rectal administration of diazepam or
visits to the emergency room to control debilitating episodes.
Importantly, NRL-1 could also provide a much needed treatment option
for those individuals who are not willing to use rectal
administration, a particular issue in the United States."
Under the terms of the option and merger agreement entered into today
between Biotie, Neurelis and Neurelis' shareholders, Biotie will make
a payment of US$1.0 million to Neurelis for the exclusive right, but
not the obligation, to acquire all of the outstanding shares of
Neurelis for a pre-defined amount of US$8.75 million, subject to
certain adjustments, to be paid in new shares of Biotie to be issued
on approval by the Board of Directors. Biotie may exercise the option
right up until the start of the pivotal pharmacokinetic clinical
studies that will form the basis of a 505 (b)(2) New Drug Application
no later than December 3, 2014). This is expected in
approximately 12-18 months' time.
Biotie's decision to exercise its option will be dependent on, among
other factors, the outcome of ongoing discussions with the FDA and
further manufacturing and pre-clinical work which Biotie will be
If the acquisition is completed, Neurelis will become a wholly owned
subsidiary of Biotie and former Neurelis shareholders would, in
addition to the pre-defined acquisition payment, be entitled to
receive additional milestone payments related to pre-determined
regulatory and commercial milestones in respect of NRL-1 and NRL-2 in
the United States and further milestones if further regulatory
approvals are obtained, payable in shares of Biotie or cash as
determined by the Board of Directors.
Turku, 4 June 2013
Biotie Therapies Corp.
NASDAQ OMX Helsinki Ltd
NRL-1 (intranasal diazepam) is a proprietary formulation of diazepam
delivered via an already marketed nasal sprayer. It is being
developed for the management of patients who require intermittent use
of diazepam to control bouts of acute repetitive seizure activity.
There are over 2.7 million people with epilepsy in the United States
with approximately 200,000 new patients diagnosed each year. It is
estimated that between 30% and 40% of these patients are uncontrolled
on oral therapy and are at-risk for acute breakthrough seizures.
Studies have shown that prolonged or repetitive seizures can cause
neurological damage and dramatically increase the risk of changes in
neuropsychological function or even death.
Presently, the only product approved in the US for the treatment of
acute repetitive seizures outside of the hospital setting, is a
rectally administered formulation of diazepam called Diastat(R).
Because of its rectal mode of administration, Diastat(R) has been
primarily relegated to use in younger pediatric patients (usually
less than 10 years of age). The majority of patients with acute
repetitive seizures however, are currently seen in emergency rooms
and treated with intravenous benzodiazepines. Most of these patients
are admitted to the hospital. Intranasal diazepam has the potential
to provide a superior alternative to either rectal administration of
Diastat(R) or the need to visit the emergency room for intravenous
administration of drugs.
ABOUT 505(b)(2) pathway TO New Drug Application
Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act in the
United States was established to avoid unnecessary duplication of
studies already performed on a reference drug, which in the case of
NRL-1 is diazepam, in general and a rectally administered formulation
of diazepam called Diastat(R), in particular.
Because approval can rest in part on data already accepted by the FDA
or otherwise available in the public domain, fewer and smaller
studies may be required, thus mitigating costs and shortening
development time. The 505(b)(2) pathway could provide relatively
fast-track New Drug Application for NRL-1 in due course provided that
all the regulatory requirements can be satisfied.
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
H. Lundbeck A/S, has received European marketing authorization for
the reduction of alcohol consumption in adult patients with alcohol
dependence who have a high level of alcohol consumption; it was
launched in April 2013 in a number of European countries and further
launches are planned through 2013 and 2014. In addition, Biotie has a
strategic collaboration with UCB Pharma S.A. covering tozadenant
which is transitioning into Phase 3 development for Parkinson's
disease. Biotie shares are listed on NASDAQ OMX Helsinki Ltd.
Neurelis, Inc. is a San Diego-based specialty pharmaceutical company
organized to license, develop, and commercialize product candidates
for epilepsy and the broader central nervous system ("CNS") market.
Neurelis leverages expertise in the development and commercialization
of CNS compounds and strong relationships with leading researchers
and clinicians in these markets to advance unique product candidates
to address significant unmet medical needs.
For further information, please contact:
President and CEO
tel. +358 2274 8900
Investor Relations Manager
tel. +358 2 274 8900
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