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NeuroSearch A/S - H1 Report 2011

25-08-11 kl. 25/8 2011 06:56 | NeuroSearch 3,50 (-0,28%)

Announcement
25 August 2011

Below please find the first part of the NeuroSearch H1 2011 report. The full
report is included in the enclosed PDF file.

------------------------------------------------

The Board of Directors of NeuroSearch A/S (NEUR) today considered and adopted
the company's interim report for the six months ended 30 June 2011. An
operating loss of DKK 143 million was reported for the period (H1 2010: a loss
of DKK 168 million).

The loss after tax was DKK 148 million (H1 2010: a loss of DKK 120 million).
Net financials for the period amounted to DKK 5 million (H1 2010: net income of
DKK 19 million).

As of 30 June 2011, the company's cash and cash equivalents including
securities totalled DKK 352 million. Securities primarily consist of highly
liquid short-term bonds. In addition, NeuroSearch will receive a total of DKK
54 million in payments for staff working on projects under the alliance with
Janssen. Moreover, the company has unused credits of DKK 15 million.

In this interim report, the company publishes for the first time segment
information for its two businesses: Specialty Pharma and NsDiscovery. Specialty
Pharma is the company's specialty pharma business focused on completing the
development and marketing of Huntexil®. NsDiscovery is managing the company's
early drug discovery, out-licensing of product candidates targeting
non-specialist indications and the company's partnerships.

Specialty Pharma reported an operating loss of DKK 90 million for the period
(H1 2010: a loss of DKK 112 million), which was primarily related to the
development of Huntexil® and related employees in the drug development
organisation, research activities on early projects as well as a relative share
of group administrative and infrastructure costs.

NsDiscovery reported an operating loss of DKK 53 million for the period (H1
2010: a loss of DKK 56 million), primarily related to revenue and cost from the
Lilly and Janssen agreements and related employees in the research
organisation, as well as a relative share of group administrative and
infrastructure costs.

Outlook for 2011
For the full year 2011, NeuroSearch adjusts its guidance to an operating loss
of approximately DKK 300 million against the previous guidance of a loss of
approximately DKK 325 million. The improvement is primarily due to
lower-than-expected development costs for Huntexil®.

Important events in Q2

-- NeuroSearch announced that the FDA's and the EMA's scientific advice
regarding the clinical development programme for Huntexil® stated that a
new Phase III study will be necessary to support an application for
marketing approval. Both regulatory authorities have supported the use of
total motor score (TMS) as the primary endpoint. The Phase IIb and III
studies HART and MermaiHD have shown significant improvement of TMS in
patients with Huntington's disease undergoing treatment with Huntexil®. The
details of the development programme will be finalised and announced in Q3
2011.

-- The first patient from the HART Phase IIb clinical study was enrolled in
the Open HART safety extension study. Open HART was planned and initiated
at the request of patients who had completed the HART study and expressed a
desire to continue treatment with Huntexil®. As of 22 August 2011, 78
patients had enrolled in the Open HART study.

-- The compassionate use program, that followed the six-month open-label
extension of the MermaiHD study, currently includes 129 patients receiving
Huntexil®.

-- NeuroSearch announced the conclusions of the scientific advice from the FDA
and the EMA regarding the development programme for tesofensine for the
treatment of overweight and obesity. This clarified the framework for a
Phase III development programme for the period until registration.
NeuroSearch is looking for a partner for the completion of the development
and commercialisation of tesofensine.

-- In May, NeuroSearch extended the existing partnership agreement with
Janssen until August 2013. The total payments to NeuroSearch under the
agreement are unchanged.

Events after the balance sheet date

-- On 7 July 2011, NeuroSearch sold its 30.1% stake in Sophion Bioscience A/S
when Biolin Scientific AB took over full ownership of Sophion. The
company's proceeds amount to approximately DKK 40 million, of which DKK 37
million are expected to be received in Q3 2011 and the remaining DKK 3
million before the end of 2012. The proceeds will affect net financials in
the Q3 income statement with approximately DKK 32 million recognised as
income from the divestment of an associated company.
-- Preliminary data for seridopidine and ordopidine has revealed a metabolite
which requires further toxicological studies. NeuroSearch therefore
postpones Proof of Concept studies until 2012. These findings do not
influence the ongoing development of Huntexil®.

Patrik Dahlen
CEO

Telephone conference
NeuroSearch will host a telephone conference today at 3.00 pm CET (2 pm UK
time, 9 am New York time) at which the interim report for the six months ended
30 June 2011 will be reviewed. Patrik Dahlen, CEO, and René Schneider, EVP &
CFO, will participate in the conference, which will be conducted in English and
with access via the following telephone numbers: UK and international +44 207
509 5139, US +1 718 354 1226 and Denmark +45 3271 4767. The conference call can
also be accessed via the company's website www.neurosearch.com.

The corresponding presentation will be available at the company's website just
prior to the teleconference.

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 listed on NASDAQ
OMX Copenhagen A/S (NEUR) and specialising in central nervous system (CNS)
disorders. The company consists of two independent businesses. Specialty Pharma
is the company's specialty pharma business focused on completing the
development and marketing of Huntexil®, a unique drug in Phase III for the
treatment of the motor symptoms of Huntington's disease. NsDiscovery is
managing the company's early drug discovery and research, out-licensing of
product candidates targeting non-specialist indications, and the company's
partnerships. The company has strategic research and development alliances with
Janssen and Lilly as well as a licence agreement with Abbott.




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