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NeuroSearch reports on scientific advice from the EMA on the clinical development programme for Huntexil®

24-05-11 kl. 24/5 2011 06:46 | NeuroSearch 3,50 (-0,28%)

Announcement
24.05.2011

-- NeuroSearch has received written scientific advice from the EMA regarding
the clinical development programme for Huntexil® in the treatment of
Huntington's disease
-- Based on the scientific advice, a new confirmatory Phase III study is
needed prior to submission of a Marketing Authorisation Application in
Europe
-- NeuroSearch plans to announce a revised timeline for the global development
programme for Huntexil®, based on the consolidated advice from the FDA and
EMA, by end of June 2011

NeuroSearch (NEUR) has now received scientific advice from both the United
States Food and Drug Administration (FDA) and the European Medicines Agency
(EMA) on the clinical development plans for Huntexil® in Huntington's disease.
Based on the advice from both the FDA and EMA, additional confirmatory data is
needed to support the regulatory submission. The design of the new confirmatory
clinical study will be defined based on the consolidated advice from the FDA
and EMA.

The new Phase III study will have the Total Motor Score (TMS) as the primary
efficacy endpoint.[1] Additional supportive measures of clinical relevance will
also be included to characterise the overall benefit/risk assessment. Timelines
for the development programme will be announced by the end of June 2011.

Patrik Dahlen, CEO of NeuroSearch commented on the feedback from the FDA and
EMA:
"Having received the feedback from both the FDA and the EMA, we can now
finalise the design of the development programme for Huntexil® to meet the
needs of the regulatory authorities and thus bring Huntexil® towards filing. We
are pleased that the Total Motor Score is the agreed primary endpoint and that
we can accommodate the advice given by both the US and European Authorities in
a common global programme."

NeuroSearch maintains the company's financial expectations for the full
financial year 2011, with 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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