BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE
September 25, 2007
Biotie has started the first phase I clinical trial with its fully human VAP-1 monoclonal antibody as it has received the final regulatory approval to do so. The study start triggers a EUR 2 million payment from Roche.
This first-in-man study evaluates the safety, tolerability, and pharmacokinetics of intravenously administered antibody in healthy volunteers. Results are expected during the second quarter of 2008.
In November 2006, Biotie and Roche signed an option agreement for Biotie's fully human antibody program targeting Vascular Adhesion Protein-1 (VAP-1) in inflammatory diseases.
Under the terms of the agreement, Roche will pay an option initiation fee of EUR 5 million, which grants Roche an exclusive option right to an exclusive, worldwide license agreement for Biotie's fully human antibody targeting VAP-1, excluding Japan, Taiwan, Singapore, New Zealand, and Australia. The option initiation fee will be paid in two instalments. Biotie received the first instalment of EUR 3 million in 2006 and Roche will pay the second instalment of EUR 2 million in 2007 triggered by the study start. The initial option right will end upon completion of Phase I. Roche may extend the option right to later development points by paying additional fees. Biotie will retain all rights to the program until a license is granted to Roche.
Inhibiting VAP-1 reduces inflammation by regulating the migration of leukocytes, or white blood cells, to inflamed tissues. Pathological accumulation of white blood cells in tissue is a common feature in many autoimmune diseases, such as rheumatoid arthritis, ulcerative colitis, and psoriasis. |
