Biotie updates outlook: Intends to develop SYN120

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News Desk 2018

Feb 28, 2014 at 2:00 AM

Biotie updates outlook: Intends to develop SYN120 internally and will not exercise its option to acquire Neurelis until further notice

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 2014. 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 acquire Neurelis. 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. Timo Veromaa President and CEO For further information, please contact: Virve Nurmi, Investor Relations Manager tel. +358 2 274 8900, 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. [HUG#1765337]

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