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Biotie Therapies Oyj BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE June 18, 2008 at 10.15 a.m.
BIOTIE'S VAP-1 ANTIBODY PROGRAM TO PROCEED TO CLINICAL STUDIES IN RHEUMATOID ARTHRITIS AND PSORIASIS PATIENTS
Top-line data from the first-in-man study with Biotie's fully human VAP-1 monoclonal antibody BTT-1023 have become available. The study was conducted in a clinical pharmacology unit in the United Kingdom and investigated the safety, tolerability and pharmacokinetic characteristics of single intravenous doses of BTT-1023 in healthy volunteer subjects.
A total of 35 subjects, of whom 29 received BTT-1023, were enrolled into the placebo-controlled study. BTT-1023 was generally well tolerated and no serious adverse events were reported in the study. Among the five subjects who received the highest dose, facial flushing was reported by two subjects with accompanying facial oedema in one of the two. These were reported during or shortly after the infusion and are not uncommon events in association with intravenous administration of therapeutic protein drugs. No cytokine release or fever was observed in any subject. All adverse events were fully reversible and required no particular intervention.
The data from the study support proceeding to clinical studies with repeated doses of the antibody. These studies are expected to be carried out in rheumatoid arthritis and psoriasis patients and will aim to establish appropriate dosing regimens for subsequent therapeutic studies and provide initial information on the therapeutic potential of BTT-1023. The studies are expected to start in the end of 2008.
Turku June 18, 2008
Biotie Therapies Corp.
Timo Veromaa President and CEO
For further information, please contact:
Timo Veromaa, President and CEO, Biotie Therapies Corp. tel. +358 2 274 8901, e-mail: timo.veromaa@biotie.com
www.biotie.com
Distribution:
OMX Nordic Exchange Helsinki Main Media
Biotie and Roche have signed an option agreement for the antibody program targeting VAP-1. Under the terms of the agreement, Roche has paid 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 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.
The company does not expect Roche to use its option during 2008.
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.
