close

Mergers and Acquisitions

Date: 2013-06-04

Type of information: Company acquisition

Acquired company: Neurelis (USA)

Acquiring company: Biotie Therapies (Finland)

Amount: up to $ 8.75 million

Terms:

* On July 11, 2014, Biotie Therapies announced that it has decided not to exercise its exclusive option to acquire Neurelis. In consideration of the timely transfer of the program to Neurelis, Biotie and Neurelis have agreed that Biotie may recover the cost of its investment to date in Neurelis' lead product NRL-1 through a share of future revenue generated by Neurelis. Neurelis plans to commence the remaining development program and proceed with clinical trials which have been agreed with the FDA. NRL-1 is a proprietary intranasal formulation of diazepam for pediatric and adult epilepsy patients who experience acute repetitive seizures.

* On February 28, 2014, Biotie has announced that the company will not exercise its option to acquire Neurelis until further notice. 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 $ 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 $ 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.

* On June 4, 2013, Biotie Therapies has announced that it has obtained an exclusive option to acquire 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. Under the terms of the option and merger agreement 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' 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 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.

Details:

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.

Related:

CNS diseases

Is general: Yes