- ACR16 for Huntington's disease: Target recruitment of 420 Huntington's
patients completed in the European Phase III study, MermaiHD

- Tesofensine for obesity: FDA has granted an End of Phase II meeting and
confirmed a date in Q2 2009

- ABT-107: Discontinuation of further development in Phase I (Abbott
collaboration)


Recruitment completed in Phase III study with ACR16 in Huntington's disease

NeuroSearch has successfully completed the recruitment of patients in MermaiHD,
the European Phase III study of ACR16, a dopaminergic stabiliser and the
company's novel drug candidate for the treatment of Huntington's disease. The
recruitment is completed less than a year after the first Huntington's patient
was screened for the study, which, with 420 patients planned for enrolment, is
the biggest Huntington's disease trial that has ever been performed in Europe.

MermaiHD is a multi-centre, randomised, double-blinded and placebo-controlled
study to evaluate the efficacy and safety of ACR16 as a novel treatment for
Huntington's disease. In the study, Huntington's patients are randomised to
receive either 45 mg ACR16 once daily, 45 mg ACR16 twice daily or placebo over
26 weeks of treatment. The study is performed at centres in eight European
countries including Austria, Belgium, France, Germany, Italy, Portugal, Spain
and the United Kingdom.

To date, 80 patients who have completed the 26 weeks of randomised treatment in
MermaiHD have elected to continue in the six month, open-label extension to the
study, and the first patients are approaching one year treatment with ACR16.
So far, the safety profile of ACR16 has been very satisfactory.

MermaiHD is performed in collaboration with the European Huntington's Disease
Network (EHDN), an association of investigators dedicated to improving the care
of patients with Huntington's disease through clinical research. Their efforts
to help identify eligible patients and support participating clinics have
played a significant role in the timely recruitment for the study.

MermaiHD is a Phase III study and part of NeuroSearch's pivotal development
programme for ACR16, which also comprises HART, a Phase IIb study, being
conducted in North America. HART was initiated in October 2008 and patient
recruitment is expected to complete later in 2009.

Dieter Meier, MD, CMO of NeuroSearch, comments:
“We would like to thank the patients and caregivers, who, by their
participation, are making this study possible. Thanks should also go to the
Huntington's Disease associations of the participating countries, who have
helped in creating awareness of the study among patients. Together we have
succeeded in recruiting more than 400 patients with Huntington's disease in
less than a year. This is in absolute accordance with our plans, and the
completion of patient recruitment in MermaiHD, the largest study ever conducted
with a novel drug in Huntington's disease in Europe, is a very important
milestone for us.”

Flemming Pedersen, CEO of NeuroSearch, adds;
“We are excited about the prospects of launching ACR16 in 2011 as a novel and
better treatment for Huntington's disease. In this area, the need for better
drugs is huge, and bringing ACR16 to the market to help improve lives for both
patients and their relatives will mark a tremendous change for our company.”


Tesofensine for obesity - End of Phase II meeting in Q2 2009

NeuroSearch has been granted an End of Phase II meeting with the FDA on
tesofensine for the treatment of obesity, and a meeting date in the second
quarter of 2009 has been agreed.

In a Phase II Proof-of-Concept study, TIPO-1, including 203 patients with
obesity (average BMI of 34.5 and an average weight of 100 kg), 24 week
treatment with tesofensine resulted in an out-standing placebo-controlled
weight-loss of approximately 10 %. The full results of the study was published
in the Lancet in October 2008 with the conclusion that tesofensine elicits more
than double the weight-loss of existing anti-obesity drugs and should be
evaluated in Phase III studies.

Through 2008, NeuroSearch has performed a number of additional clinical
studies, thereby adding to the substantial efficacy and safety data package
supporting the strong profile of tesofensine. All available data together with
the planned Phase III programme will now be discussed with the FDA, and
NeuroSearch also prepares for meetings with EMEA, the European Healthcare
authorities later in 2009.

After the regulatory interactions, NeuroSearch will finally decide on the
pivotal Phase III programme for tesofensine as well as on the strategy for
final development of the drug.


Discontinuation of ABT-107 in Phase I development under collaboration with
Abbott

ABT-107 is an alpha7-specific neuronal nicotinic receptor (NNR) modulator,
which Abbott has been evaluating in preclinical and clinical Phase I studies
under a license agreement with NeuroSearch. Based on results from these
studies, Abbott and NeuroSearch have decided not to pursue further development
of the compound at this time.


Flemming Pedersen
CEO



Contact person:
Flemming Pedersen, CEO, telephone: +45 4460 8214 or +45 2148 0118
Hanne Leth Hillman, Vice President, Director of Investor Relations & Corporate
Communications, telephone: +45 4460 8212 or +45 4017 5103

 
About ACR16 - A novel dopaminergic stabiliser for Huntington's disease
ACR16 belongs to a class of active agents called dopaminergic stabilisers,
which have the unique ability to both strengthen and inhibit dopamine-regulated
functions in the brain, depending on the base level of dopamine activity.
Dopamine is an important neurotransmitter in the brain, and the dopaminergic
system plays a central role in the control of motor and mental functions. In
preclinical studies dopaminergic stabilisers have demonstrated the ability to
stabilise motor, cognitive and psychiatric dysfunction, and they do this
without compromising normal brain functions.

NeuroSearch is evaluating ACR16 in a pivotal programme for the treatment of
Huntington's disease, comprising of a European Phase III study, MermaiHD, and a
North American Phase IIb confirmatory study, HART. ACR16 has previously been
evaluated in a Phase II Proof of Concept study in Huntington's disease with
positive results showing a statistically significant improvement in patients'
motor function (gait and Parkinsonism) as well as improvements in their
attention and psychiatric symptoms. Further, ACR16 has been studied in clinical
Phase I studies in Huntington's disease, Parkinson's disease and schizophrenia
with favourable and consistent results.

ACR16 was discovered by NeuroSearch, which holds the global rights to the
compound. Both the European (EMEA) and the US (FDA) Health Authorities have
granted ACR16 orphan drug designation for the treatment of Huntington's
disease.


About NeuroSearch - Company profile
NeuroSearch (NEUR) is a Scandinavian biopharmaceutical company listed on Nasdaq
OMX Copenhagen. The company's core business covers the development of novel
drugs, based on a broad and well-established drug discovery platform focusing
on ion channels and CNS disorders. A substantial share of NeuroSearch's
activities is partner financed through an alliance with Eli Lilly and Company
and collaborations with GlaxoSmithKline (GSK) and Abbott. The drug pipeline
comprises seven clinical (Phase I-III) development programmes: ACR16 for
Huntington's disease (Phase III), tesofensine for obesity (Phase III ready),
ABT-894 for ADHD (Phase II) in partnership with Abbott, ACR325 for Parkinson's
disease (Phase II ready), ACR343 for schizophrenia (Phase II ready), ABT-560
for the treatment of various CNS disorders (Phase I) in collaboration with
Abbott, and NSD-788 for anxiety/depression (Phase I). In addition, NeuroSearch
has a broad portfolio of preclinical drug candidates and holds equity interests
in several biotech companies.

fonds.09-09 - pipeline update - uk - final.pdf