Combined entity’s nine clinical candidates headed by alcohol-dependence drug scheduled for filing this year.

Biotie Therapies is acquiring Switzerland-based CNS drug development firm Synosia Therapeutics in an all-shares deal valued at about €93.6 million (roughly $126 million) based on Biotie’s €0.58 per share price at market close yesterday evening. The merger will generate a combined entity with nine clinical-stage drug candidates and operations in the U.S., Finland, and Switzerland.

Under terms of the deal Finland Biotie will issue 161,448,371 shares to shareholders and warrant-holders of Synosia, in exchange for the entire issued share capital and outstanding warrants of Synosia. The proposed takeover still has to undergo final ratification by Biotie shareholders, but the firm says stakeholders representing more than 30% of the firm’s total number of votes have agreed to sanction the transaction.

The combined pipeline is headed by Biotie’s Phase III-stage alcohol-dependence therapy, nalmefene, which is being partnered worldwide with Lundbeck. Just a week ago the firms reported positive data from the first two of three nalmefene Phase III trials, and a third Phase III study is due to report during the second quarter of 2011. Submission of a marketing authorization application in Europe is projected for the second half of the year. Biotie’s earlier-stage clinical pipeline includes three Phase I candidates. Ronomilast is a PDE4 inhibitor in development for the treatment of COPD, and two VAP-1 antodies are in development for a range of indications, including rheumatoid arthritis. Rights to these candidates for certain territories in Asia Pacific have been granted to Seikagaku.

Synosia’s clinical pipeline includes Phase I and Phase II-stage candidates for the treatment of Parkinson disease, Alzheimer disease, bipolar disorder, drug dependence, and post-traumatic stress disorder. Lead adenosine A2a antagonist SYN-115 is in development for the Parkinson disease indication. During October 2010 Synosia licensed SYN-115 to UCB worldwide for nonorphan indications. The deal also gives UCB rights to a second Phase II-stage Parkinson disease compound, SYN-118 (nitisinone), which has previously been approved and is marketed by Swedish Orphan Biovitrum as Orfadin®, for treating the orphan disease hereditary tyrosinemia type 1.

The deal between Synosia and UCB for SYN-115 and SYN-118 included a $20 million equity investment in Synosia from its new partner, and could lead to Synosia earning up to $725 million in additional regulatory and commercial milestone payments.

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