Biotie updates outlook: Intends to develop SYN120 internally and will not exercise its option to acquire Neurelis until further notice
ET | Source:Biotie Therapies
BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 28 February 2014
at 8.55 a.m.
Biotie updates outlook: Intends to develop SYN120 internally and will not
exercise its option to acquire Neurelis until further notice
SYN120: Biotie has been in advanced discussions for a partnership for further
development and commercialization of SYN120, its oral, dual antagonist of the 5-
HT6 and 5HT2a receptors. These two distinct properties could result in a unique
therapeutic profile for SYN120 combining pro-cognitive and antipsychotic
activities. SYN120 has completed single and multiple ascending dose Phase 1
clinical studies and a Phase 1 positron emission tomography imaging study to
determine therapeutic dose for subsequent Phase 2 studies. The Company has now
concluded that Biotie will be better served by progressing SYN120 internally to
the next stage of development. Preparations for a Phase 2 study in Alzheimer's
disease have started, with the study expected to begin recruitment by the end of
NRL-1 is a proprietary intranasal formulation of diazepam which Biotie has been
developing to help patients with epilepsy requiring intermittent use of diazepam
to manage bouts of acute and repetitive seizures. The product became part of
Biotie's portfolio in June 2013 when the Company signed an exclusive option to
Under the terms of the option and merger agreement, Biotie has made a payment of
USD 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
USD 8.75 million, subject to certain adjustments. Any purchase of Neurelis would
be paid for in new shares of Biotie that would be issued on approval by the
Board of Directors. Biotie may exercise the option 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 3 December 2014).
In Q4 2013, Biotie was engaged in conducting further manufacturing and pre-
clinical work with NRL-1 under the option arrangement. However, after a thorough
assessment the Company has now concluded that its timely access to market is not
guaranteed and that Biotie will not exercise the option to acquire Neurelis in
H1 2014 as initially expected. Biotie will not make any further significant
investment into this opportunity until further notice.
Turku, 28 February 2014
Biotie Therapies Corp.
President and CEO
For further information, please contact:
Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900, e-mail: email@example.com
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.
GlobeNewswire, a Nasdaq company, is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.