Biotie: BTT1023 receives Orphan Drug Designation in the United States
(Thomson Reuters ONE) -
BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 26 August
2016 at 2.30 p.m. (EET)
Biotie: BTT1023 receives Orphan Drug Designation in the United States
The United States Food and Drug Administration (FDA) has granted Orphan Drug
Designation in the United States for Biotie's BTT1023 drug candidate for the
treatment of primary sclerosing cholangitis (PSC). PSC is a chronic and
progressive fibrotic liver disease for which there are currently no FDA-approved
treatments.
BTT1023 is a fully human monoclonal antibody targeting Vascular Adhesion Protein
-1 (VAP-1), and it is currently being studied for PSC in a Phase 2a study (the
BUTEO study). The BUTEO study is conducted in partnership with the University of
Birmingham, UK, and is supported by grant funding awarded by the UK's National
Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation
Programme, funded and managed by NIHR on behalf of the Medical Research Council
- NIHR partnership. The grant holder and Co-Investigator for the study is
Professor David Adams, Director of the NIHR Biomedical Research Unit in Liver
Disease and Centre for Liver Research at the University of Birmingham.
The two-stage study design for BUTEO includes a pre-planned interim analysis,
and based on current estimates, it is expected that the requisite number of
patients will have been treated to enable the interim analysis in the first half
of 2017.
In March 2015, the European Commission granted BTT1023 Orphan Drug Designation
in the EU for the treatment of PSC. Biotie retains full rights to BTT1023.
Turku, 26 August 2016
Biotie Therapies Corp.
Antero Kallio
CEO
For further information, please contact:
Virve Nurmi, Biotie Therapies Corp.
tel. +358 2 274 8900, e-mail: virve.nurmi(at)biotie.com
Distribution:
www.biotie.com
Nasdaq Helsinki Ltd
Main media
INFORMATION REGARDING BIOTIE
Biotie is a biopharmaceutical 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
H. Lundbeck A/S. The current development products include tozadenant for
Parkinson's disease, which is in 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. Biotie is a part of Acorda Therapeutics Inc.
Group ("Acorda") and its shares, excluding of those owned by Acorda, are
currently subject to a redemption process in accordance with the Finnish
Companies Act.
For more information, please visit www.biotie.com.
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq 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
Unternehmensinformation / Kurzprofil:
Datum: 26.08.2016 - 13:30 Uhr
Sprache: Deutsch
News-ID 491318
Anzahl Zeichen: 3570
contact information:
Town:
Turku
Kategorie:
Business News
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