Combined firm will have drugs in late-stage development against alcohol dependence and Parksinson disease.

Finnish firm Biotie Therapies is buying Italian CNS and pain therapeutics specialist Newron Pharmaceuticals in a share-based deal valued at some €45 million. Newron’s stock was up more than 23% by mid-morning on announcement of the news, while Biotie’s was up a more conservative 7%.

The proposed deal will give former Newron stockholders a 21.1% stake in the combined entity. Based on the initial consideration shares, the deal represent an implied one-day premium for Newron shareholders of 38.3%.

“We have been working hard to find the right partner, and in Biotie we believe we have the best combination to create a European entity with critical mass to ensure that our pipeline will generate value for our shareholders,” remarks Luca Benatti, Newron CEO.

The merger isn’t expected to affect Biotie’s existing operations or organizations in Finland and the U.S., but the firms say the structure of Newron’s orgainzaiton in Italy and Switzerland will be reviewed and restructuring is planned.

The merged firm will have two late-stage drug candidates: Biotie’s opioid receptor antaogonist nalmefene completed Phase III trials as a treatment for alcohol dependence, and Newron’s safinamide is undergoing Phase III studies as an adjunctive treatment for Parkinson disease.

In January Biotie and nalmefene development partner Lundbeck reported positive data from the first two of three Phase III trials. At the time the firms said submission of a nalmefene MAA was projected for the second half of the year.

Merck Serono has exclusive, worldwide rights to develop and commercialize Newron’s safinamide for the treatment of Parksinon disease, Alzheimer disease, and other therapeutic indications. In November the firm reported positive results from an 18-month extension to a prior six-month safinamide trial. The study was part of the Phase III development program for safinamide, which includes the ongoing Motion and Settle  studies.

The Biotie/Newron combined pipeline also includes clinical- and preclinical-stage drugs for the treatment of CNS disorders and autoimmune/inflammatory disorders. Biotie’s SYN-115 is an adenosine 2A receptor inhibitor in Phase II development for the treatment of Parkinson disease. It has been licensed to UCB for worldwide development and commercialization.

SYBN-118 is a small molecule 4-hydroxyphenyl-pyruvate dioxygenase inhibitor for the treatment of movement disorders. It is subject to an option agreement with UCB. SYN-120 is a 5-HT6 receptor antagonist candidate for treating Alzheimer disease and other cognitive disorders, to which Roche has an option. The dopamine beta-hydroxylase inhibitor SYN-117 is a currently undergoing a DoD-funded Phase II study for the treatment of post-traumatic stress disorder.

BTT-1023 is a fully human antibody targeting vascular adhesion protein-1 (VAP-1). It is expected to start in proof-of-concept studies during 2012 and has completed two Phase Ib studies in RA and psoriasis. Seikagaku has licensed the rights to develop and commercialize VAP-1 in Japan, Taiwan, Singapore, New Zealand, and Australia. Development partners are being sought for Biotie’s small molecule PDE4 inhibitor candidate for the treatment of chronic obstructive pulmonary disease.

Meanwhile, further clinical development of Newron’s Phase II-stage ralfinamide for the treatment of pain and psychiatric disorders is under evaluation. Additional Newron projects include the neuroprotective candidate NF0220, which is in Phase I/II development for the treatment of Alzheimer disease and RA, and the late-preclincial-stage NW-3509 for the treatment of schizophrenia.

Newron recently acquired a license to develop the Phase II-stage CNS disease candidates pruvanserin and sarizotan from Merck KGaA. Under terms of this deal Merck Serono retains a buy-back option for each compound on the completion of proof-of-concept trials.

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