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03/3/14 - €0.31
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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, such as 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 diseases. The company has a development portfolio with various small molecule and biological drug candidates at various stages of clinical development. Its advanced product, Selincro (nalmefene) reduces alcohol consumption in adult patients with alcohol dependence who have a high level of alcohol consumption. The company’s drug development projects also include Tozadenant (SYN115), an oral, potent, and selective adenosine A2a receptor antagonist in Phase 3 development, which enters the brain and modulates regions associated with motor and non-motor function; SYN120, an oral, potent, and selective antagonist of the 5-HT6 receptor, which has completed single and multiple ascending dose Phase 1 clinical studies and a Phase 1 positron emission tomography imaging study to determine therapeutic dose; and BTT-1023 (VAP-1 antibody) that has completed Phase Ib clinical trials for the treatment of rheumatoid arthritis and psoriasis. In addition, its drug development projects comprise Nepicastat (SYN117), a cocaine dependence enzyme dopamine beta hydroxylase inhibitor focusing on conducting Phase 2 clinical trial; and Ronomilast, an oral phosphodiesterase-4 inhibitor with therapeutic potential in chronic inflammatory disorders. The company has strategic collaboration with UCB Pharma S.A. Biotie Therapies Corp. is based in Turku, Finland.

35 Employees
Last Reported Date: 10/31/14

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biotie therapies oyj (BTH1V) Key Developments

Biotie Therapies Corp. Reports Earnings Results for the Fourth Quarter and Full Year Ended December 31, 2014

Biotie Therapies Corp. reported earnings results for the fourth quarter and full year ended December 31, 2014. For the quarter, net loss was EUR 32.4 million compared to net profit of EUR 1.7 million a year ago. Revenues were EUR 1.9 million against EUR 5.8 million a year ago. Cash out flows from operating activities of EUR 4.7 million against EUR 2.8 million a year ago. Loss per share was EUR 0.07. For the year, the company reported revenues were EUR 14.9 million against EUR 27.7 million a year ago. Cash out flow from operating activities was EUR 14.1 million against cash inflows from operating activities of 10.6 million a year ago. Loss per share was EUR 0.08 against earnings per share of EUR 0.01 a year ago.

Biotie Provides Portfolio Update on Tozadenant

Biotie announced further detail on its clinical development plan for tozadenant, an adenosine A2a antagonist in development for Parkinson's disease (PD). Biotie plans to conduct one Phase 3 study in 882 PD patients experiencing levodopa related end-of-dose 'wearing-off' (motor fluctuations) in which participants will be randomized in a double-blind manner 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 time spent in the "off" state in patients taking tozadenant as compared to placebo between baseline and week 24. Secondary endpoints will include "on" time without troublesome dyskinesia, the Unified Parkinson's Disease Rating Scale, Clinical Global Impression of Change and Patient Global Impression of Change. The placebo-controlled period will be followed by a 52 week open label treatment period to collect additional clinical safety data. The planned Phase 3 study is expected to start recruiting patients in the United States, Canada and selected European countries in the middle of 2015. Based on current estimates, top-line data is expected to be available by the end of 2018. Biotie has previously reported positive data from a 420-patient Phase 2b study evaluating tozadenant in PD patients experiencing levodopa related end-of-dose 'wearing-off'. Full data from this trial was published in Lancet Neurology in 20141. The trial met its primary endpoint of a highly significant decrease in "off" time vs. placebo, as well as demonstrating efficacy across multiple secondary endpoints. The Phase 3 protocol will largely replicate that of the Phase 2b study. Biotie expects that the published Phase 2b study will be considered the first of two pivotal studies required for registration for tozadenant in PD patients with end-of-dose 'wearing-off'. Biotie is considering financing options which may involve a capital raise to fully fund the tozadenant Phase 3 program to approval.

Biotie Therapies Mulls Financing Options

Biotie Therapies Corp. (HLSE:BTH1V) is considering financing options which may involve a capital raise to fully fund the tozadenant Phase 3 program to approval.


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