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Last €0.21 EUR
Change Today -0.007 / -3.21%
Volume 282.8K
As of 11:30 AM 07/3/15 All times are local (Market data is delayed by at least 15 minutes).

biotie therapies oyj (BTH1V) Snapshot

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52 Week High
06/22/15 - €0.26
52 Week Low
05/12/15 - €0.14
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Current Stock Chart for BIOTIE THERAPIES OYJ (BTH1V)

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biotie therapies oyj (BTH1V) Details

Biotie Therapies Corp., a drug development company, focuses on the development of drugs for neurodegenerative and psychiatric disorders primarily in Finland and the United States. Its products include Selincro (nalmefene), a dual-acting opioid system modulator that reduces alcohol consumption in alcohol dependent individuals; Tozadenant (SYN115), an oral, potent and selective adenosine A2a receptor antagonist for the treatment of Parkinson’s disease that is in Phase III development; and Nepicastat (SYN117) an orally administered inhibitor for the treatment for cocaine dependence, which has completed in Phase II trial. The company’s products also comprise BTT1023, a monoclonal antibody targeting Vascular Adhesion Protein 1 in Phase II development in fibrotic conditions and received orphan drug designation for the treatment of primary sclerosing cholangitis; and SYN120, an oral, potent, dual antagonist of the 5-HT6 and 5-HT2A receptors that has completed single and multiple ascending dose Phase I clinical studies and a Phase I positron emission tomography imaging study to determine therapeutic dose for subsequent Phase II studies. Biotie Therapies Corp. is based in Turku, Finland.

40 Employees
Last Reported Date: 06/12/15

biotie therapies oyj (BTH1V) Top Compensated Officers

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biotie therapies oyj (BTH1V) Key Developments

Biotie Therapies Corp.(NasdaqGS:BITI) added to NASDAQ Composite Index

Biotie Therapies Corp. has been added to Nasdaq Composite Index.

Biotie Therapies Corp. Announces Board Changes

Biotie Therapies Corp. announced that the terms of Don M. Bailey and Mahendra G. Shah as members of Biotie's Board of Directors commence and the number of Board members increases from five to seven. Following the addition of new Board members, the Board of Directors has determined the composition of its committees. Don M. Bailey was elected the Chairman and Bernd Kastler and Merja Karhapaa the members of the Board's Audit Committee. Furthermore, William Burns was elected the Chairman and Guido Magni, Ismail Kola and Mahendra G. Shah the members of the Nomination and Remuneration Committee. The Board of Directors has also elected Bernd Kastler as the Vice Chairman of the Board.

Biotie Therapies Corp Announces Agreement with FDA on a Special Protocol Assessment for Tozadenant Phase 3 Study

Biotie Therapies Corp. has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the Phase 3 study of tozadenant in Parkinson's disease (PD). The Phase 3 study (TOZ-PD) will evaluate efficacy and safety of tozadenant compared to placebo in PD patients taking levodopa and experiencing end-of-dose wearing off. A Special Protocol Assessment is a written agreement with the FDA on the design, size and planned analysis for a clinical trial. An SPA may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of new public health concerns. A positive outcome of TOZ-PD, along with the results of the completed Phase 2b study are expected to be sufficient to support a claim of efficacy for tozadenant in patients with Parkinson's disease with motor fluctuations (end-of-dose wearing off) and could form the basis of an NDA submission. Final marketing approval will be dependent, amongst other factors, on the overall results of the trial. The planned study is a randomized, double-blind, placebo controlled Phase 3 study in 450 PD patients experiencing levodopa related end-of-dose wearing off, in which participants will be randomized to receive twice daily doses of 60mg or 120mg of tozadenant or placebo, in addition to their standard anti-PD medications, for 24 weeks. The primary endpoint will be reduction in time spent in the "off" state in patients taking tozadenant as compared to placebo between baseline and week 24. The double-blind phase of the study will be followed by an open-label treatment phase of a one year duration.


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