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Biotie Therapies Oyj: Biotie announces agreement with FDA on a Special Protocol Assessment for tozadenant Phase 3 study

at 09.00 a.m.

Biotie announces agreement with FDA on a Special Protocol Assessment for
tozadenant Phase 3 study

Biotie Therapies 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.

Timo Veromaa, President and CEO of Biotie, commented: "The agreement with FDA
is another important milestone in our effort to bring tozadenant through the
regulatory process and make it available to patients to address a significant
unmet medical need".

Turku, 25 May 2015

Biotie Therapies Corp.

Timo Veromaa
President and CEO

Further information:

For further information, please contact:

Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900, e-mail:


NASDAQ OMX Helsinki Ltd
Main media

About tozadenant (SYN115)

Tozadenant is an oral, potent and selective adenosine A2a receptor antagonist
being developed for the treatment of Parkinson's disease. Tozadenant has
displayed clinically relevant and statistically significant effects in
Parkinson's disease, across multiple pre-specified evaluation metrics, in a
420 patient Phase 2b study. Full data from the study were published in Lancet
Neurology in July 2014, and it is expected that this successful study will be
accepted as one of the two pivotal studies required for registration in the
United States. Tozadenant is currently transitioning into Phase 3 development
as part of Biotie's proprietary portfolio.

About Biotie

Biotie is a specialized drug development company focused on products for
neurodegenerative and psychiatric disorders. Biotie's development has
delivered Selincro (nalmefene) for alcohol dependence, which received
European marketing authorization in 2013 and is currently being rolled out
across Europe by partner Lundbeck. The current development products include
tozadenant for Parkinson's disease, which is transitioning into Phase 3
development, and two additional compounds which are in Phase 2 development
for cognitive disorders including Parkinson's disease dementia, and primary
sclerosing cholangitis (PSC), a rare fibrotic disease of the liver.


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Biotie Therapies Oyj via Globenewswire


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