Biotie Therapies Oyj : Biotie purchases option to acquire Neurelis, Inc.

   Biotie Therapies Oyj : Biotie purchases option to acquire Neurelis, Inc.


Biotie purchases option to acquire Neurelis, Inc.

  *Opportunity to develop late-stage product for treatment of epileptic

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 system ("CNS").

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 repetitive seizures. 

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

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 (but no
later than December 3, 2014). This is expected in approximately 12-18 months'

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 conducting.

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.

Timo Veromaa
President and CEO

For further information, please contact:

Timo Veromaa President and CEO
tel. +358 2274 8900, email:

Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900, e-mail:

NASDAQ OMX Helsinki Ltd

Main Media


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®. Because of its rectal
mode of administration, Diastat® 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®
or the need to visit the emergency room for intravenous administration of

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®,
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

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.


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information contained therein.

Source: Biotie Therapies Oyj via Thomson Reuters ONE
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