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news.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.
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The 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 I clinical studies and a Phase I positron emission tomography imaging study to determine therapeutic dose for subsequent Phase II 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 II 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 $1m 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 $8.75m, 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 the fourth quarter of 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 the first half of 2014 as initially expected.
Biotie will not make any further significant investment into this opportunity until further notice.