Company will spin out preclinical assets and end SSAO inhibitor collaboration with Roche.

Biotie Therapies announced a major restructuring program that will see the firm focus its operations solely on its clinical development pipeline, and spin-out its Radebeul-based Biotie Therapies business in Germany through a management buyout. Roche and Biotie Therapies have in addition mutually agreed to end their research and option agreement that had been centered on developing small molecule inhibitors against semicarbazide-sensitive amine oxidase (SSAO). The restructuring will have no effect on Biotie’s ongoing collaboration with Lundbeck for the worldwide development and commercialization of its lead Phase III-stage alcohol dependence therapy nalmefene, the firm stresses.

Biotie will also retain a minority interest in the newly established Radebeul spin-out, Biocrea, and will provide the firm with up to €4.8 million in funding over the next 12 months. All the employees and preclinical assets of the Radebeul site will also be transferred to Biocrea. Thomas Kronbach, currently Biotie CSO, will leave to head the newly formed company.

Job cuts are also expected at Biotie’s headquarters in Turku, Finland, where the headcount is expected to be reduced by 15 to 22. The overall restructuring efforts are expected to save Biotie about €4 million from 2011 onwards,

“We are confident that the steps we would be taking today would allow us to focus on our core competencies and to efficiently advance our existing clinical pipeline,” comments Timo Veromaa, Biotie president and CEO. “The resulting streamlined organization and corporate structure would enable us to build a stronger clinical pipeline and additionally consider other strategic options to deliver longer-term sustainable growth going forward.”

Biotie is focused on the development of new drugs for CNS and inflammatory disorders. Its clinical pipeline is headed by the Lundbeck-partnered opioid receptor antagonist nalmefene, which has already completed two Phase III studies in alcohol dependence. Another three Phase III studies are ongoing, which are planned to enroll over 1,800 patients, Biotie notes. Two of these Phase III trials, each of which will enroll approximately 600 patients, are due to report first results toward the end of 2010.

Biotie’s clinical-stage products also include Ronomilast, a phosphodiesterase 4 (PDE4) inhibitor in development for chronic inflammatory diseases. The primary indication is chronic obstructive pulmonary disease (COPD), for which a Phase I multiple ascending dose trial was successfully completed in April 2010.

A fully human mAb candidiate against Biotie’s vascular adhesion protein-1 (VAP-1) target is separately being prepared for Phase II trials. In January Biotie reported positive top-line data from a clinical study with VAP-1 antibody in rheumatoid arthritis patients, and in September the firm reported top-line data from a Phase I study in patients with plaque psoriasis. Seikagaku has licensed rights to develop and commercialize the VAP-1 antibody in Japan, Taiwan, Singapore, New Zealand, and Australia.

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