Below please find the first part of the NeuroSearch Q3 report 2008. The full
text is available in the enclosed pdf document.
Announcement
NeuroSearch A/S - Q3 report 2008
Today, the board of directors of NeuroSearch considered and approved the
company's interim report for the period 1 January to 30 September 2008.
For this period, NeuroSearch reports a financial loss after tax of DKK 267.9
million (Q3 2007: a loss of DKK 222.9 million) and capital resources totalling
DKK 605.7 million at 30 September 2008 (DKK 258.0 million at 30 September
2007).
During the third quarter of 2008 and the following period, NeuroSearch has met
a number of important milestones and continues to advance and build value into
its broad pipeline of drug development programmes. The progress of our business
is highly satisfactory.
The ACR16 pivotal programme in Huntington's diesase, consisting of the European
MermaiHD study and the US HART study, is progressing well and according to
plan. Over the past months, NeuroSearch has succesfully added to the
outstanding efficacy and safety data package behind tesofensine for the
treatment of obesity and completed all clinical Phase III preparations. As part
of these preparations, NeuroSearch has finalised a full pivotal Phase III
development plan, in collaboration with external clinical experts in the field
of obesity. In parallel, NeuroSearch has continued the dialogue with potential
partners.
The management's report for the third quarter 2008 contains a review of
NeuroSearch's business strategy and plans focusing on the company's two late
stage in-house development programmes; ACR16 for the treatment of Huntington's
disease and tesofensine for the treatment of obesity as well as on the drug
discovery portfolio and related business and financing aspects.
Overview of key development milestones and activities in Q3 2008:
• Tesofensine (Phase III in preparation for obesity/Type 2 diabetes)
- Positive 24-week interim results from TIPO-4 (Phase II extension study) show
an outstanding and clinically highly relevant placebo-controlled effect of
approximately 13 kg after a combined tesofensine treatment period of 48 weeks.
- Detailed results from TIPO-2, a metabolic evaluation study of tesofensine,
demonstrate that the drug exerts its unique weight loss efficacy through both
appetite suppression and a favourable impact on energy and fat metabolism. The
outcome of TIPO-2 further supports tesofensine's potential as a superior new
treatment for obesity and Type 2 diabetes.
- An abuse liability study and a cardiovascular feasibility study has been
completed. The aim of the two studies was to further strengthen the safety
profile of the drug; the one with regard to risk of abuse and the other with
regard to cardiovascular safety. The results were favourable, supporting Phase
III development.
• ACR16 (in Phase III for Huntington's disease)
- FDA approval received of the IND for ACR16 and of the HART study as part of
NeuroSearch's ongoing pivotal programme in Huntington's disease. NeuroSearch
started dosing patients in the HART study in October.
• NS2359 (in Phase II for depression)
- Patient enrolment has been completed in two large clinical Phase IIb studies
under the licence agreement with GlaxoSmithKline (GSK). Results are expected in
H1 2009.
• NSD-847 for the treatment of psychoses has been chosen as a new development
candidate and added to the product pipeline.
Most important events after the third quarter of 2008:
• Publication in The Lancet of the results from TIPO-1, a proof-of-concept
Phase II study with tesofensine for obesity concluding that tesofensine can
produce a weight loss twice that of currently approved obesity drugs and that
Phase III development is warranted.
• Initiation of patient dosing in the US HART study as part of the ongoing
pivotal programme with ACR16 for the treatment of Huntington's disease.
NeuroSearch retains its financial guidance for 2008, expecting a loss before
financials in the region of DKK 400 million. This guidance does not include any
kind of success-based payments that may be realised during the year from
neither existing nor new partnership agreements.
Thomas Hofman-Bang
Chairman of the board
Telephone conference:
NeuroSearch hosts a teleconference later today, 17 November 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 and
Director of IR & Corporate Communications, will present the Q3 Report 2008 and
answer questions. The teleconference will be conducted in English and the
telephone number is +44 (0)20 7162 0077. 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 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 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.
