NeuroSearch updates on the clinical development programme for Huntexil®
30-06-11 kl. 30/6 2011 07:58 | NeuroSearch 3,50 (-0,28%)
Announcement
30.06.2011
-- NeuroSearch is establishing a global development programme for Huntexil® in
close collaboration with key opinion leaders and other experts
-- NeuroSearch has seen keen interest among these opinion leaders in
contributing to the design of an optimal Phase III programme
-- During Q3 2011, NeuroSearch will decide upon the final details of the
development programme and release a revised timeline
-- The preliminary activities and preparations for the initiation of a new
Phase III programme progress as planned.
Since the feedback from the American (FDA) and European (EMA) health
authorities, NeuroSearch (NEUR) has worked on designing a confirmatory Phase
III programme for Huntexil® for the treatment of Huntington's disease. As
previously announced, it has been decided that a new Phase III study will have
the Total Motor Score, the TMS, as its primary endpoint.[1] Additional
endpoints of clinical relevance will be included to characterise the overall
benefit/risk assessment.
NeuroSearch is continuously in close dialogue with several key opinion leaders
and experts to ensure an optimal design of a new Phase III programme.
Concurrently, NeuroSearch will organise an expert seminar in Q3 with the aim of
determining the final details of the programme after which we expect to be able
to disclose it.
NeuroSearch is also planning and preparing all other preclinical and clinical
activities, which together with data from the new Phase III study will form the
basis of a later application for marketing approval.
NeuroSearch maintains the company's financial expectations for the full
financial year 2011 of an expected loss before financials and other shares of
result in the region of DKK 325 million.
Patrik Dahlen
CEO
Contact persons:
Patrik Dahlen, CEO, telephone: +45 4460 8214 or +45 2629 7296
René Schneider, EVP & CFO, telephone: +45 4460 8700 or +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.
[1]The TMS is the motor part of the Unified Huntington's Disease Rating Scale
(UHDRS).
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