Biotie to continue development of and maintain global rights to BTT-1023, its novel VAP-1 antibody for inflammatory disease
Biotie announced today that it maintains global development and commercialization rights to BTT-1023 (ex-Japan, Taiwan, Singapore, New Zealand, and Australia), following Roche's decision not to exercise its opt-in right for strategic portfolio reasons. BTT-1023 is Biotie's novel fully human monoclonal antibody targeting vascular adhesion protein-1 (VAP-1) that has recently completed a successful Phase Ib study in rheumatoid arthritis patients and is due to complete a Phase Ib trial in psoriasis patients around mid-year 2010.
Timo Veromaa, Chief Executive Officer of Biotie, commented: "VAP-1 is a novel target in inflammatory disease and BTT-1023 represents a truly exciting and differentiated product for the treatment of rheumatoid arthritis, psoriasis and other inflammatory conditions. Maintaining the rights to BTT-1023 in key pharmaceutical markets enables us to initiate discussions with potential partners and allows us to control how we maximize the value of this product. We have a solid financial position and look forward to continuing the development of BTT-1023 to its next value inflection point."
In January 2010, Biotie reported top-line data from a Phase Ib study (BTT12-CD015) in rheumatoid arthritis patients. The study evaluated the safety, tolerability and pharmacokinetics of repeated doses (up to 8mg/kg) of the intravenously administered antibody in 24 rheumatoid arthritis patients with an inadequate response to methotrexate. The trial showed that BTT-1023 was generally well tolerated, and no serious or severe adverse events were reported. Although not designed to enable statistical evaluation of therapeutic activity, patients receiving the higher doses of BTT-1023 had better responses in several standard assessments of treatment effect (including DAS28 and ACR scores) than those patients receiving placebo.
Turku, 22 April, 2010
Biotie Therapies Corp.
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About BTT-1023 and VAP-1
BTT-1023 is a novel, fully human monoclonal antibody based on Medarex Inc.'s HuMab technology. The product targets vascular adhesion protein-1 (VAP-1), an endothelial adhesion molecule. 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 inflammatory diseases such as rheumatoid arthritis, ulcerative colitis, and psoriasis. Biotie has licensed the rights to develop and commercialize BTT-1023 in Japan, Taiwan, Singapore, New Zealand and Australia to Seikagaku Corporation.
About Study BTT12-CD015
Study BTT12-CD015, conducted within the EU, was a randomized, placebo-controlled, double-blind, multiple ascending dose study conducted in 4 sequential cohorts of 6 patients. Within each cohort, 5 patients were randomized to receive active drug and 1 patient to receive placebo. The BTT-1023 doses in the sequential cohorts were 1, 2, 4, and 8mg/kg. In this 4 month study, 5 doses of study drug were administered intravenously at 2 week intervals with post-treatment follow-up continuing for 9 weeks after the last dose. Study subjects were required to have active rheumatoid arthritis with a predefined level of breakthrough symptoms while on a stable background regiment of methotrexate. Safety and tolerability were assessed with adverse event inquiries and comprehensive laboratory analyses, while treatment response was assessed with a number of subjective and objective assessments that are widely used in rheumatoid arthritis trials.
Biotie Therapies Corp.
Biotie is a drug discovery and development company focused on central nervous system and inflammatory diseases. It has a broad range of innovative small molecule and biological drug candidates at different stages of clinical and pre-clinical development. Biotie's products address diseases with high unmet medical need and significant market potential, including addiction and psychotic disorders, rheumatoid arthritis, psoriasis and chronic obstructive pulmonary disease (COPD). The most advanced product, nalmefene for alcohol dependence, is currently in phase III clinical development by licensing partner H. Lundbeck A/S.
The commercial value of the pipeline has been demonstrated through existing alliances with top-tier global pharmaceutical companies such as Lundbeck, Roche and Pfizer. Biotie has operations in Turku, Finland and Radebeul, Germany.
Biotie shares are listed on NASDAQ OMX Helsinki Ltd.
For more information, please refer to www.biotie.com