Biotie Therapies and Seikagaku have agreed to terminate their license agreement for Biotie's VAP-1 antibody program, BTT-1023. The decision also nixes Seikagaky’s option for Biotie's VAP-1 SSAO small molecule inhibitors.
Biotie had granted Seikagaku exclusive development and commercialization rights in Japan, Taiwan, Singapore, New Zealand, and Australia in April 2003, and the arrangement was built around Seikagaku's expertise in locomotive diseases. "Based on recently generated exciting data in animal models, we have reprofiled the VAP-1 antibody program to primarily target fibrotic diseases, and this therapeutic focus is no longer aligned with Seikagaku's business strategy,” explains Timo Veromaa, CEO of Biotie.
“Regaining the Asia-Pacific rights to BTT-1023 gives us the opportunity to build a fully global development strategy in the fibrosis disease area, which has a high level of unmet medical need," Veromaa notes.
BTT-1023 is a fully human mAb that specifically binds to VAP-1. Biotie previously demonstrated encouraging efficacy and safety for BTT-1023 in early clinical studies in RA and psoriasis patients as well as in a range of preclinical models of inflammatory diseases including COPD plus certain neurological conditions.
More recently, Biotie generated data indicating that VAP-1 also has an important role in fibrotic diseases. This data, generated in part in collaboration with National Institute for Health Research Liver Biomedical Research Unit at the University of Birmingham, reveals significant potential for BTT-1023 in certain niche liver inflammatory fibrotic diseases, the company points out.
The VAP-1 antibody program is Phase II ready, according to Biotie. The company is currently optimizing the scale-up of the manufacturing process for BTT-1023 and expects to start proof-of-concept clinical studies in selected indications in the second half of 2012.