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Last €0.17 EUR
Change Today -0.001 / -0.59%
Volume 773.7K
As of 11:29 AM 05/29/15 All times are local (Market data is delayed by at least 15 minutes).

biotie therapies oyj (BTH1V) Snapshot

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biotie therapies oyj (BTH1V) Details

Biotie Therapies Corp. operates as a drug development company. It focuses on the development of drugs for neurodegenerative and psychiatric disorders. 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; NRL-1 a proprietary intranasal formulation of diazepam for the treatment of epilepsy; Nepicastat (SYN117) an orally administered inhibitor for the treatment for cocaine dependence, which is in Phase II trial. The company’s products also comprise BTT-1023 a monoclonal antibody for treatment of inflammatory diseases focusing on conducting Phase 2 clinical trial; and SYN120 an oral, potent, dual antagonist of the 5-HT6 and 5HT2a 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. The company has strategic collaboration with UCB Pharma S.A. Biotie Therapies Corp. is based in Turku, Finland.

40 Employees
Last Reported Date: 05/14/15

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biotie therapies oyj (BTH1V) Key Developments

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.

Biotie Therapies Corp. Reports Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2015

Biotie Therapies Corp. reported unaudited consolidated earnings results for the first quarter ended March 31, 2015. For the quarter, the company reported revenue of EUR 0.9 million against EUR 5.1 million a year ago. Net loss was EUR 5.9 million against EUR 1.7 million a year ago. Cash outflow from operating activities was EUR 5.4 million against EUR 5.4 million a year ago. Loss per basic & diluted share was EUR 0.01 against EUR 0.00 a year ago. Operating loss was EUR 5.625 million against EUR 1.522 million a year ago. Loss before taxes was EUR 5.894 million against EUR 1.719 million a year ago. Investments in property, plant and equipment was EUR 0.051 million against EUR 0.102 million a year ago.

Biotie Therapies Corp., Q1 2015 Earnings Call, May 06, 2015

Biotie Therapies Corp., Q1 2015 Earnings Call, May 06, 2015


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