NeuroSearch provides an update on the development plan for Huntexil® in the treatment of Huntington's disease following the End of Phase II meeting with the FDA
23-03-11 kl. 23/3 2011 15:56 | NeuroSearch 3,50 (-0,28%)
Announcement
23.03.2011
-- NeuroSearch has received preliminary feedback from the FDA regarding the
development programme for Huntexil® in the treatment of Huntington's
disease
-- Based on the preliminary feedback, new confirmatory clinical data to
support an NDA submission in the US will be required
-- NeuroSearch will await confirmation from FDA as well as feedback from EMA,
which is expected in Q2 2011, before defining the global development plan
and regulatory strategies for Huntexil®
NeuroSearch (NEUR) has completed an End of Phase II meeting with the United
States Food and Drug Administration (FDA). Based on the preliminary feedback
from the FDA, a US regulatory submission will require additional clinical data
to support the effect of Huntexil® in the treatment of Huntington's disease.
A plan for the generation of additional clinical evidence for Huntexil® in
Huntington's disease is currently being developed. However, before defining the
global development and regulatory strategies, NeuroSearch will await the final
meeting minutes from the FDA and feedback from EMA, which is expected in the
second quarter of 2011.
Patrik Dahlen
CEO
Contact persons:
Patrik Dahlen, CEO, telephone: +45 2629 7296
René Schneider, EVP & CFO, telephone: +45 2911 2097
About NeuroSearch
NeuroSearch A/S is a European based biopharmaceutical company, specialising in
CNS diseases, and listed on NASDAQ OMX Copenhagen A/S (NEUR). The company has a
pipeline of speciality CNS drugs, including Huntexil® (pridopidine), a unique
orphan drug in Phase III for the treatment of Huntington's disease. NeuroSearch
is building commercial competences with a view to commercialising Huntexil®
through an in-house marketing and sales organisation.
NeuroSearch has a well-established drug discovery division, NsDiscovery, with
unique capabilities in the field of ion channels and CNS diseases. The company
has strategic drug discovery and development alliances with Janssen
Pharmaceutica and Eli Lilly as well as a licence collaboration with Abbott.
NeuroSearch also has equity interests in a number of unlisted companies in the
Life Science industry.
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