NeuroSearch A/S - Interim report for H1 2010
25-08-10 kl. 25/8 2010 10:52 | NeuroSearch 3,50 (-0,28%)
Below please find the first part of the NeuroSearch interim H1 report 2010. The
entire report is available in the enclosed PDF document.
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Copenhagen, 25 August 2010 - Today, the Board of Directors of NeuroSearch A/S
(NEUR) considered and adopted the company's interim report for the period 1
January to 30 June 2010.
The operating result for the period was a loss of DKK 168.0 million (a loss of
DKK 204.1 million in the same period of 2009). The company's capital resources
totalled DKK 808.4 million at 30 June 2010 (DKK 488.9 at 30 June 2009),
consisting primarily of highly liquid short-term bonds and guaranteed future
payments from partners. Financial net income for the period positively affected
net results by DKK 20.5 million.
Key business events and development in the second quarter of 2010 and the
subsequent period:
• Huntexil® (pridopidine) - Huntington's disease
- End of April, NeuroSearch announced that the results from the Phase III
MermaiHD study demonstrated a unique and positive effect on Huntington
patients' motor function after 26 weeks' treatment with Huntexil® but that the
primary study endpoint, the modified Motor Score, mMS, had not been met.
Without adjustment for differences in patients' genetic disposition (CAGn), the
effect on mMS reached a p-value of 0.042 against a pre-specified significance
level of p< 0.025. Treatment with Huntexil® demonstrated a highly significant
effect (p< 0.005) on the Total Motor Score, TMS, and a good safety profile.
- The 26-week open-label extension to the MermaiHD study, having enrolled 353
patients to assess the safety of Huntexil® after 12 months' treatment, has been
completed. Study results are expected within the coming month.
- At the beginning of August, 12 weeks' treatment of 227 patients in the North
American HART study was completed. The study results are expected to be
available in connection with the 4th Annual Huntington Disease Clinical
Research Symposium which will take place on 16 October 2010 in La Jolla, USA.
- When the results from the open-label MermaiHD and the HART studies are
available in the fourth quarter of 2010, NeuroSearch will initiate dialogue
with the regulatory authorities in both Europe and North America to define the
most appropriate strategy to obtain marketing approval for Huntexil®.
- The European compassionate use programme for ex-MermaiHD study patients is
now established in all the eight countries where the study was conducted. At
this time, almost 40% of the patients who completed the open-label extension
phase have - in consultation with their treating physicians - elected to
continue treatment with Huntexil®.
- In the US and Canada, there is also a keen interest for continued treatment
among ex-HART study patients, and NeuroSearch is working to give also these
patients early access to the drug.
• Tesofensine - Obesity
- A new Phase III plan is in preparation and in this relation NeuroSearch is
closely following the US regulatory authorities' evaluation of other drugs to
treat obesity. A revised Phase III plan is expected to be ready for discussion
with the US and the European regulatory authorities in the fourth quarter of
2010.
- NeuroSearch will continue the dialogue with potential partners with the aim
of signing a licensing agreement before the initiation of Phase III.
• Other clinical programmes
- ACR343 (seridopidine) - Schizophrenia;
Concurrently with the preparation of a Phase II study in the treatment of
schizophrenia, NeuroSearch has decided to investigate also the potential for
ACR343 in the treatment of selected neurologic and psychiatric speciality
indications. Phase II is expected to be initiated in the first half of 2011.
WHO has granted ACR343 the generic name seridopidine, supporting the
establishment of dopaminergic stabilisers as a novel class of pharmaceutical
agents designated dopidines.
- ACR325 (ordopidine) - Parkinson's dyskinesias;
NeuroSearch has initiated preparations for a Phase II Proof of Concept study
with ACR325 as a novel treatment for L-Dopa-induced dyskinesias in Parkinson's
disease. This study is expected to start in the first half of 2011.
ACR325 is also a dopaminergic stabiliser and has been granted the generic name
ordopidine.
• Discovery and development alliances with Eli Lilly and Janssen Pharmaceutica
- The collaborations with Eli Lilly and Janssen Pharmaceutica are progressing
satisfactorily and are expected to lead to the selection of new development
candidates within the coming 6-12 months.
• Associated companies
- In the beginning of August, NsGene A/S (27% owned by NeuroSearch) announced
the signing of an extended collaboration agreement with Biogen Idec concerning
Neublastin, which is in Phase I development. In connection with the signing of
the expanded agreement, NsGene received an upfront payment of USD 6 million.
• Organisation
- On 24 August, NeuroSearch announced the appointment of Patrik Dahlen as new
CEO of the company. Patrik Dahlen brings more than 17 years of broad-based
managerial experience from the international life science industry and with
effect from 15 September replaces Flemming Pedersen, who will take up a new
position in another company.
- NeuroSearch is also working to appoint a new CMO and announcement is expected
in the second half of 2010.
NeuroSearch adjusts the financial guidance for the year 2010 to a loss before
financials and other shares of results of approximately DKK 350 million from
DKK 400 million as previously announced. NeuroSearch maintains a high level of
activity but an enhanced focusing has reduced certain research and development
costs.
Flemming Pedersen Thomas Hofman-Bang
CEO Chairman of the Board
Contact persons:
Flemming Pedersen, CEO, telephone: +45 4460 8214 or +45 2148 0118
Hanne Leth Hillman, Vice President, Director of Investor & Capital Market
Relations, telephone: +45 4460 8212 or +45 4017 5103
Telephone conference
The interim report for H1 2010 will be presented at a telephone conference
today at 3 pm Copenhagen time (2 pm London time, 9 am New York time).
Participating in the conference will be CEO Flemming Pedersen, Vice President &
CFO Anita Milland and Vice President and Director of Investor & Capital Market
Relations Hanne Leth Hillman. The telephone conference will be conducted in
English and the dial-in numbers are: UK and International +44 207 509 5139, US
+1 718 354 1226 and DK +45 3271 4767.
NeuroSearch - Company profile
NeuroSearch A/S is a leading CNS focused and European based biopharmaceutical
company listed on NASDAQ OMX Copenhagen A/S (NEUR). The company's core business
is development of novel drugs to treat diseases of the central nervous system
(CNS), and the pipeline comprises eight products in clinical development (Phase
I-III). These include Huntexil® (pridopidine), a unique orphan drug in Phase
III development for the treatment of Huntington's disease, and tesofensine
ready for Phase III development as a novel treatment of obesity.
NeuroSearch is founded on a well-established drug discovery platform in the
field of ion channels and monoamine transporters, ensuring the continuous
production of novel preclinical development candidates. The company has
strategic drug discovery alliances with Janssen Pharmaceutica and Eli Lilly as
well as a licence collaboration with Abbott. Further, NeuroSearch has equity
interests in a number of private companies in the Life Science industry.
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