NeuroSearch A/S - Interim report for the first half-year of 2008

Announcement

The full text is available in the enclosed pdf document. 


NeuroSearch A/S - Interim report for the first half-year of 2008

Today, the board of directors of NeuroSearch considered and approved the
company's interim report for the period 1 January to 30 June 2008. 

For this period, NeuroSearch reports a financial loss after tax of DKK 185.9
million (1H 2007: a loss of DKK 149.1 million) and capital resources totalling
DKK 716.3 million at 30 June 2008 (DKK 354.9 million at 30 June 2007). 

The entire business of the company has performed highly satisfactorily in 2008
till date, and NeuroSearch has continued to make substantial progress in its
pipeline of drug candidates. 

Among the most important developmental events in the first half-year of 2008
was the initiation of NeuroSearch's pivotal ACR16 programme in Huntington's
disease with dosing of the first patients in the European Phase III MermaiHD
(Multinational European Multicentre ACR16 study in Huntington's disease) study.
This was followed in July by the US Food and Drug Administration's (FDA's) IND
approval and acceptance of the US HART (Huntington's disease ACR16 Randomised
Trial) study as part of the same programme. NeuroSearch considers ACR16 to be a
highly attractive product opportunity and, based on a full assessment of its
commercial potential in Huntington's disease, NeuroSearch has initiated first
steps to pursue commercialisation of ACR16 through an inhouse sales and
marketing organisation, thereby enabling the company to retain the full value
potential of its product. 

Also in 2008, NeuroSearch has reported several positive and confirmatory
clinical results from its development programme with tesofensine for the
treatment of obesity and Type 2 diabetes, supporting the company's advancing
Phase III preparations with this product candidate. 

Overview of key activities and events in the second quarter of 2008: 

• In April, NeuroSearch dosed the first patients in MermaiHD, a European Phase
III clinical study of ACR16 for the treatment of Huntington's disease. 

• In June, NeuroSearch announced positive results from a Phase II study of
ABT-894, in adults with Attention Deficit Hyperactivity Disorder (ADHD).
ABT-894 is licensed to Abbott. 

• Further in June, NeuroSearch announced the successful completion of Phase I
studies with ACR325 and the decision to advance development into clinical
studies in both Parkinson's disease and bipolar disorder. 

• In May 2008, NeuroSearch issued 300,000 new shares in a directed offering
subscribed for by institutional investors at a price of DKK 280 per share to
finance an ACR16 Phase III related milestone payment of SEK 100 million
(approximately DKK 80 million/approximately EUR 10.7 million) to the sellers of
Carlsson Research AB. 

• In April, two new members were elected to NeuroSearch's board of directors,
both with broad experience from the international pharmaceutical industry: Dr.
Anders Ullman, Executive Vice President, Nycomed Altana GmbH and Dr. Gerard van
Odijk, Group Vice President & CEO of Teva Pharmaeuticals Europe. At the same
time, Thomas Hofman-Bang, CEO of NKT Holding was elected new chairman of the
board. 

Most important events after the second quarter of 2008: 

• In July, NeuroSearch reported positive results from a 24-week interim
analysis of TIPO-4 (48 weeks' Phase II extension study) with tesofensine for
the treatment of obesity and Type 2 diabetes. The interim analysis confirmed
the half-year weight loss of approximately 9 kg (placebo-controlled) seen with
tesofensine in TIPO-1 and provided the first long-term data, showing a
placebo-controlled mean weight loss of approximately 13 kg after a combined
48-week tesofensine treatment. 

• Also in July, NeuroSearch received an IND approval from the FDA for ACR16 as
part of the ongoing pivotal clinical programme in Huntington's disease. 

• In August, NeuroSearch reported the results of a detailed analysis of data
from TIPO-2, a metabolic evaluation study with tesofensine. The results show
that tesofensine's outstanding efficacy in weight reduction is obtained through
both appetite suppression and a favourable impact on energy and fat metabolism.
The positive results strongly support tesofensine's potential as a superior new
treatment for obesity and Type 2 diabetes. 

• In July, NeuroSearch's drug discovery activities yielded a new product
candidate to the development pipeline: NSD-847 for the treatment of psychoses. 

• In August, NeuroSearch's licence partner GlaxoSmithKline (GSK) has completed
patient enrolment in two Phase IIb studies of the drug candidate NS2359 for
depression. Both studies are still ongoing. 

• As part of its Phase III preparations, NeuroSearch has just completed an
Abuse Liability study and a cardiovascular feasibility study. The results of
both studies are supportive of the continued development of tesofensine. 

NeuroSearch revises its financial guidance for 2008 to a loss before financials
in the region of DKK 400 million from previously a loss in the region of DKK
450 million. The forecast does not include any kind of success-based payments
that may be realised during the year from neither existing nor new partnership
agreements. 

Pursuant to Article 5a of NeuroSearch's Articles of Association, the board of
directors has resolved to issue up to 350,000 warrants to its members, the
executive management and employees, entitling the holders to subscribe for
shares with a total nominal value of up to DKK 7,000,000. The allocation among
the board of directors, executive management and employees has not yet been
made. The exercise price of the warrants will be fixed as the average trading
price of NeuroSearch's shares during the period 20 August 2008 - 2 September
2008 plus 10% p.a. in the vesting period (3 years). Under Article 5a of the
Articles of Association, the exercise price cannot be set lower than DKK 359.
The value of the warrants granted is approximately DKK 23 million based on the
Black & Scholes model, equivalent to approximately 17% of the total annual
gross payroll cost. NeuroSearch has no other bonus plans. 

Revised financial calendar for 2008
The date for the announcement of NeuroSearch's report for the third quarter
2008 has been changed to 17 November 2008. 


Thomas Hofman-Bang
Chairman of the board


Telephone conference
A teleconference will be held today, 27 August 2008 at 3 pm Copenhagen time (2
pm London time, 9 am New York time). Flemming Pedersen, CEO, Anita Milland,
Vice President & CFO and Hanne Leth Hillman, Vice President & Director of IR &
Corporate Communications, will present the 2008 half-year report and answer
questions. The telephone conference will be conducted in English and the
telephone number is +44 (0)20 7162 0025. The corresponding PowerPoint
presentation will be available at www.neurosearch.com. 


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



NeuroSearch (NEUR) is a Scandinavian biopharmaceutical company listed on the
OMX Nordic Exchange Copenhagen A/S. 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 its activities is partner financed through a broad alliance with
GlaxoSmithKline (GSK) and collaborations with, among others, Abbott and
Astellas. NeuroSearch's drug pipeline comprises 14 clinical (Phase I-III)
development programmes: ACR16 for Huntington's disease (Phase III), tesofensine
for obesity and in Type 2 diabetes (Phase III in preparation), NS2359 for
depression (Phase II) and ADHD (Phase II) in partnership with GSK, ABT-894 for
ADHD (Phase II) and pain (Phase II) in partnership with Abbott, ACR16 for
schizophrenia (Phase I) in partnership with Astellas, ACR325 for Parkinson's
disease (Phase II in preparation) and bipolar disorder (Phase II in
preparation), ABT-107 and ABT-560 for the treatment of various CNS disorders -
both (Phase I) in collaboration with Abbott, NSD-644 for pain (Phase I) in
partnership with GSK, 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.