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DANMARKS STØRSTE INVESTORSITE MED DEBAT, CHAT OG NYHEDER

Supportive clinical data on tesofensine, NeuroSearch's late-stage anti-obesity drug, presented at the 17th European Congress on Obesity

07-05-09 kl. 7/5 2009 15:58 | NeuroSearch 3,50 (-0,28%)

- Results from three previously reported clinical studies with tesofensine are
presented in an oral presentation, a “hot topic” presentation and a poster
presentation

Copenhagen, 7 May 2009 - NeuroSearch announces that results from three clinical
studies with tesofensine, the company's highly efficacious anti-obesity drug in
Phase II/III, are presented today and tomorrow at the 17th annual European
Congress on Obesity, which is being held from 6-9 May in Amsterdam, the
Netherlands.

The results from TIPO-5, a clinical study of tesofensine's abuse liability
potential, will be presented today 7 May at 1.30 pm - 3.00 pm CET in a hot
topic poster presentation:

“Tesofensine, a novel weight management drug, has no or minimal abuse potential”

The conclusions from the TIPO-5 hot topic poster presentation:
• Tesofensine was not associated with significant positive effects at doses
ranging from 1 mg (the maximum therapeutic dose) up to 9 mg.
• Abuse-related effects of tesofensine were lower than d-amphetamine on most
measures, as well as unscheduled controls buproprion and atomoxetine on some
measures.
• Tesofensine has minimal or no abuse potential in recreational stimulant users.

The results from TIPO-2, a clinical study of the metabolic effects of two
weeks' treatment with tesofensine in 32 overweight and obese subjects, will be
presented tomorrow 8 May at 9.30 am - 11.00 am CET in an oral presentation:

“The effect of the triple monoamine reuptake inhibitor tesofensine on energy
metabolism and appetite in overweight and moderately obese men”
- by Anders Sjödin, MD, Dr.Med.Sci. Department of Human Nutrition, University
of Copenhagen, Denmark.

Summary and conclusion from the oral presentation on results from TIPO-2:
• Study subjects experienced a significant weight-loss after two weeks, despite
efforts to maintain body weight.
• The weight reducing effect of tesofensine is mainly caused by its decreasing
appetite effect but probably also to some extent by its stimulation of
thermogenesis.

Furthermore, a poster presentation will be given tomorrow 8 May at 13.30 pm -
15.00 pm CET with results from TIPO-4, a 48-week Phase II extension study to
TIPO-1, a Proof of Concept study:

“The effect of tesofensine on weight loss: Results from a one-armed,
open-labeled extension study”

Conclusions from the presentation of results from TIPO-4:
• This one-armed, open-labelled, extension study confirms previously reported
efficacy of tesofensine, i.e. a weight loss of > 10 kg over 24 weeks and ≈ 14
kg over 48 weeks, with good tolerability and acceptable hemodynamic effects as
well as adverse events.

Earlier presented results from TIPO-1 demonstrated that 24-week treatment
resulted in an average placebo-corrected weight loss of approximately 10% and a
good safety and tolerability profile for the drug.


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


Tesofensine - A novel anti-obesity drug
Tesofensine is a monoamine reuptake inhibitor, which NeuroSearch has evaluated
in Phase II studies with out-standing effect for the treatment of obesity.
After six months of treatment, a weight loss of approx. 10% was obtained
(TIPO-1 study) and a weight loss of 13-14% was seen after 12 months of
treatment (TIPO-4 study). NeuroSearch believes that these results make
tesofensine one of the most effective anti-obesity products in late-stage
development. In October 2008, the results from TIPO-1 were published in the
highly reputed international scientific journal The Lancet with the conclusions
that tesofensine can produce a weight loss at least twice that of currently
approved anti-obesity drugs and that it should be further evaluated in Phase
III studies in order to prepare for market registration.

NeuroSearch has built up a substantial data package supporting the strong
profile of tesofensine. This includes safety data from more than 1,300
individuals having received treatment with tesofensine and of these approx.
1,150 have received relevant therapeutic doses.

NeuroSearch will decide on the final Phase III development plan following
interactions with both the FDA and EMEA in 2009.


NeuroSearch - Company profile
NeuroSearch (NEUR) is a Scandinavian biopharmaceutical company listed on Nasdaq
OMX Copenhagen. The core business of the company covers the development of
novel pharmaceutical agents, based on a broad and well-established drug
discovery platform focusing on ion channels and central nervous system (CNS)
disorders. A substantial share of the activities is partner financed through
strategic alliances with Eli Lilly and Company and GlaxoSmithKline and a
license collaboration with 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 to treat dyskinesias in 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.




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