Biotie´s VAP-1 has an important role in fibrotic diseases
The license, under which Biotie had granted Seikagaku exclusive rights for development and commercialization of its VAP-1 monoclonal antibody BTT-1023 in Japan, Taiwan, Singapore, New Zealand and Australia, was executed in April 2003 and was built around Seikagaku's expertise in locomotive diseases. The agreement, which also included an option for Biotie's VAP-1 SSAO small molecule inhibitors, has been terminated with immediate effect.
Timo Veromaa, Chief Executive Officer of Biotie commented, "Based on recently generated exciting data in animal models we have re-profiled the VAP-1 antibody program to primarily target fibrotic diseases and this therapeutic focus is no longer aligned with Seikagaku's business strategy. 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. "
Biotie has recently generated new data indicating that its proprietary target VAP-1, in addition to its clinically demonstrated role in inflammatory diseases, has an important role in fibrotic diseases. These data, generated in part in collaboration with National Institute for Health Research Liver Biomedical Research Unit at the University of Birmingham, UK, reveal significant potential for BTT-1023 in certain niche liver inflammatory fibrotic diseases. These data will be published at upcoming scientific and medical conferences and represent potentially new and exciting development opportunities for BTT-1023 in a range of conditions.
Biotie 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 H2 2012. Biotie has previously demonstrated encouraging efficacy and safety for BTT-1023 in early clinical studies in rheumatoid arthritis and psoriasis patients and in a range of preclinical models of inflammatory diseases, including COPD and certain neurological conditions. The company will continue discussions with potential partners for the indications targeting large markets.
Turku based Biotie is a specialized drug development company focused on the development of drugs for neurodegenerative and psychiatric disorders (e.g. Parkinson's disease, Alzheimer's disease and other cognitive disorders, alcohol and drug dependence (addiction) and post-traumatic stress disorder), and inflammatory and fibrotic liver disease.
The company has a strong and balanced development portfolio with several innovative small molecule and biological drug candidates at different stages of clinical development. Biotie's products address diseases with high unmet medical need and significant market potential.
Partnerships with top-tier pharmaceutical partners are in place for several programs as well as a strategic collaboration with UCB Pharma S.A. The Marketing Authorization Application for Biotie's most advanced product, SelincroTM (nalmefene) for alcohol dependence was filed in the EU by our partner H. Lundbeck A/S and was accepted for review by the European Medicines Agency in December 2011.
Biotie shares are listed on NASDAQ OMX Helsinki Ltd.