NeuroSearch regains global rights to ACR16

NeuroSearch announces that the company has regained the global rights to ACR16,
a dopaminergic stabiliser in Phase III development as a novel treatment for
Huntington's disease. 

Under a license agreement between NeuroSearch and Astellas Pharma Inc.
(Astellas), Astellas has held worldwide rights to ACR16 for all indications,
except in North America, EU, Norway and Switzerland, in which territories
NeuroSearch retained the rights to develop and commercialise the drug for
Huntington's disease. The license agreement was originally made between former
Carlsson Research AB (now NeuroSearch) and former Fujisawa (now Astellas). 

Under the now terminated licence agreement Astellas has been evaluating ACR16
in Phase I studies with a view to developing the drug as a novel treatment for
schizophrenia. Based on a strategic assessment including consideration of the
commercial and developmental challenges in this indication, Astellas has now
decided to discontinue development of ACR16 in schizophrenia and to return all
territorial and commercialisation rights to the compound to NeuroSearch.
Astellas' decision does not relate to any technical or developmental issues of
relevance for NeuroSearch's ongoing clinical programme with ACR16 or for the
drug's potential in the treatment of Huntington's disease. 

In relation to the return of rights, NeuroSearch has ensured the manufacturing
of ACR16 and also the future delivery of the drug for commercialisation. The
discontinuation of the license agreement with Astellas will not affect the
overall budget, the timing of the development programme, the production or the
estimated profitability of ACR16 going forward. 

Flemming Pedersen, CEO of NeuroSearch comments;
“We have had an excellent collaboration with Astellas in studying the same drug
candidate in two different disease areas. Given, however, that ACR16 is now in
its final stage of development for Huntington's disease we believe it to be
very valuable for NeuroSearch to hold the global rights to the product. We are
highly dedicated to our Huntington's programme and we aim at finalising the
ongoing Phase III study later this year. ” 

As a consequence of Astellas' decision to discontinue the development of ACR16
in schizophrenia, a potential milestone consideration of SEK 125 million (DKK
83.1 million/EUR 11,2 million) to the sellers of Carlsson Research following
NeuroSearch's acquisition of the company in 2006, will not become due and the
corresponding debt obligation has therefore been taken off NeuroSearch's
balance sheet. The transaction has no impact on the company's financial
results. 
 
NeuroSearch will disclose financial guidance for 2009 in connection with the
company's 2008 full year announcement on 4 March 2009. 


Flemming Pedersen
CEO


Contact persons:
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 


ACR16 - A dopaminergic stabiliser
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. 

Huntington's disease
Huntington's disease (HD) is a fatal, hereditary neurodegenerative genetic
disorder, which leads to damage of the nerve cells in certain areas of the
brain including the basal ganglia and the cerebral cortex. Patients suffering
from HD experience a wide variety of symptoms, including severe motor
disturbances (both lack of voluntary movements and involuntary movements),
cognitive impairment and psychiatric disorders. Symptoms onset is typically
around 35 and 45 years of age and patients hereafter have a life expectancy of
10 to 15 years. 

The disease occurs at a rate of about one in every 10,000 in most western
countries with an estimated 70,000 affected patients in North America and
Europe. In other parts of the world HD prevalence is lower, and the total
number of patients suffering from HD outside North America and Europe is
estimated at 30,000 to 35,000. The rate of diagnose also varies among
geographic regions. 

After symptoms onset the disease progresses without remission, and eventually
every person afflicted by Huntington's disease will require full-time care.
There is currently no cure or effective treatment for Huntington's disease and
only a limited number of novel drugs in development. 

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 9 clinical (Phase I-III) development programmes: ACR16 for
Huntington's disease (Phase III), tesofensine for obesity and type 2 diabetes
(Phase III ready), ABT-894 for ADHD (Phase II) in partnership with Abbott,
ACR325 for Parkinson's disease (Phase II in preparation) and bipolar disorder
(Phase II ready), ABT-107 and ABT-560 for the treatment of various CNS
disorders - both (Phase I) in collaboration with Abbott, ACR343 for Parkinson's
disease (Phase I) 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.