BioTie Therapies - Biotechnology partnerships

Biotie Therapies is a drug development biotechnology company with a focus on dependence disorders, inflammatory diseases and thrombosis. The most advanced drugs in development are nalmefene for alcoholism (phase III) and impulse control disorders (phase II), monoclonal VAP-1 antibody and small molecule VAP-1 SSAO enzyme inhibitor for inflammatory diseases (late preclinical), and recombinant bioheparin for thrombosis (preclinical). The company is also developing a small molecule a2b1-integrin inhibitor for thrombosis and cancer, and has extensive immaterial property rights and know-how on its K5 polysaccharide technology platform to develop carbohydrate based pharmaceuticals.

BioTie's strategy is to partner the products after proof of concept (end clinical phase II) has been obtained. If, however, strong commercial rationale exists, the company may deviate from this basic principle.

During 2003 and 2004 the following partnering agreements were concluded:

• AVENTIS: Global research and option agreement for the development of a NCE to be used as an oral product for the prevention and treatment of blood coagulation disorders. This global collaboration is based on BioTie's recombinant heparin know-how and IPR.
• Seikagaku Corporation: Licensing agreement covering the Far East territory of the company's VAP-1 monoclonal antibody programme. According to the licensing agreement Seikagaku has been granted the exclusive rights for the monoclonal antibody product against VAP-1. The territory consists of Japan, Taiwan, Singapore, New Zealand and Australia. The agreement covers three indications: rheumatoid arthritis, psoriasis and ulcerative colitis.
• Hoffman La Roche (Roche): Global (excluding the Seikagaku territory) collaboration and option agreement to develop proprietary small molecule inhibitors against VAP-1. Under the terms of the agreement, BioTie and Roche will co-develop VAP-1 small molecule inhibitor candidates. According to the agreement Roche's medical chemistry task force will provide their expertise in the optimisation of the drug candidate. Biotie development team will remain responsible for the development of the programme. At agreed decision points, Roche may use its exclusive option rights to obtain an exclusive license of any VAP-1 inhibitor candidate. Roche may extend its option rights until clinical phase IIb by paying BioTie a €5m option fee. BioTie will retain all rights to the compounds until a license agreement between Roche and BioTie has been concluded.
• Somaxon Pharmaceuticals: According to the terms of the licensing agreement covering the North American territory, BioTie has granted Somaxon an exclusive license to clinically develop, manufacture and market nalmefene for the treatment of pathological gambling and other impulse control disorders in North America .