Teleconference today at 10.30 AM Copenhagen time (9:30 AM London time, 4:30 New
York time)
The Q1 report in full is available in the enclosed PDF file.
----------------------------------
Copenhagen, 28 April 2010 - The Board of Directors of NeuroSearch A/S (NEUR)
today considered and adopted the company's interim report for the period 1
January to 31 March 2010.
The operating loss for the period was DKK 80.4 million (a loss of DKK 96.7
million in the same period of 2009).
The company's capital resources totalled DKK 907.3 million at 31 March 2010
(DKK 550.7 million at 31 March 2009), primarily consisting of highly liquid
short-term bonds and guaranteed future payments from partners. Financial net
income was positive and amounted to DKK 11.1 million, and also capital
resources were positively affected by proceeds of DKK 27.1 million from the
exercise of warrants.
Key events and activities in Q1 2010 and the subsequent period:
• Huntexil® (pridopidine) - Huntington's disease
- Today, NeuroSearch has announced that further assessment of the data from the
MermaiHD study, a large European Phase III study of 437 Huntington patients,
shows that the significance value for the primary endpoint, the modified Motor
Score (mMS) of p= 0.042 did not meet the pre-specified level of p< 0.025. With
inclusion of the clinically relevant CAGn adjustment, the p-value is < 0.02 as
previously communicated.
- The revised statistical conclusion is limited to the primary endpoint with
the statistical results as reported for the other endpoints being unchanged.
Overall, the study results confirm the unique and clinically meaningful effect
and good safety profile of Huntexil®.
- Top-line results from the MermaiHD study were announced in February,
demonstrating a significant improvement in Huntington patients' motor function
after six months treatment. This included positive effects on both voluntary
motor symptoms, dystonia and eye movements.
- Additional MermaiHD study findings provide support for a disease modifying
effect of Huntexil® and have provided the basis for the subsequent filing of
additional intellectual property.
- Enrolment into the HART study, a North American Phase II study, will be
completed on 30 April 2010 with a total of approximately 220 patients. Top-line
study results are expected in the second half of 2010.
- A total of 353 patients are enrolled into the MermaiHD 26-week open-label
extension study which is ongoing. Top-line results are expected in the second
half of 2010.
- There is interest from all of the eight European countries that participated
in the MermaiHD study, to take part in the compassionate use programme for
ex-study patients, and continued supply of Huntexil® is now approved in six
countries.
• Tesofensine - Obesity
- FDA has approved the initiation of a Phase III clinical programme including
the use of sibutramine as active comparator, enabling NeuroSearch to start
pivotal studies with tesofensine. However, management has decided to
re-evaluate the development strategy to accommodate the emerging new
competitive and regulatory landscape in obesity following EMA's withdrawal of
the market authorisation for sibutramine in Europe and an expected FDA advisory
hearing on the drug later this year.
- A revised target product profile for tesofensine and the associated Phase III
plan will be presented to the FDA later this year with the aim of establishing
the optimal frame work for a competitive development programme for the product
in weight management.
- The revised development plan implies parallel initiation of a number of Phase
III studies, and it has therefore been decided to start the pivotal programme
when a commercial partner has been selected.
- Management believes that FDA endorsement of the new target product profile
and the revised development plan is essential to ensuring an attractive
partnership agreement.
• ACR343 - Schizophrenia
- NeuroSearch is finalising the planning and preparations for a clinical Phase
II study with ACR343 as add-on to anti-psychotics for the treatment of
schizophrenia.
• ACR325 - Parkinson's dyskinesias
- In parallel with the ongoing Phase Ib study, NeuroSearch is planning 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
second half of 2010.
• Discovery and development alliances with Lilly, Janssen and GSK
- The collaborations with Lilly and Janssen are progressing well and are
expected to lead to the selection of new development candidates during 2010.
- GSK has announced a significant refocusing of its drug discovery efforts in
neuroscience area away from psychiatry disorders. GSK continues to pursue
assets that are in clinical stage development but does not expect to exercise
any early options for the compounds under the alliance. To the extent possible,
these assets will in accordance with and to support the strategic focus of the
company be re-profiled in areas, where NeuroSearch can undertake development
through to market registration, or be developed in collaboration with other
partners.
NeuroSearch retains its financial guidance for the full year 2010, expecting a
loss before financials and other shares of results in the region of DKK 400
million.
In connection with the announcement of the Q1 report for 2010, Flemming
Pedersen, CEO of NeuroSearch, commented:
“Following the positive results obtained in our Huntexil® programme, we are now
engaging all possible efforts in ensuring the drug's optimal and prompt
advancement towards the market and the patients. Further, we see a whole new
drug class being established around Huntexil®, which is expected to lead to new
development efforts targeting several CNS disorders with high medical needs.
Also, we are focused on completing the re-positioning of tesofensine in the
emerging new regulatory environment for weight management therapy where we see
a continuous and growing need for novel and efficient treatment options."
Flemming Pedersen
CEO
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 Q1 2010 will be presented at a telephone conference
today at 10:30 am Copenhagen time (9:30 am London time, 4:30 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.
The Q1 report will also be presented at the Annual General Meeting of
NeuroSearch, held today at 4.00 pm CET at the Radisson Blu Falconer Hotel &
Conference Center, Falkoner Allé 9, DK-2000 Frederiksberg, Copenhagen.
NeuroSearch - Company profile
NeuroSearch (NEUR) is a Scandinavian biopharmaceutical company listed on NASDAQ
OMX 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 central nervous system (CNS) disorders. A substantial share
of the activities is partner financed through strategic alliances with Eli
Lilly and Janssen and a license collaboration with Abbott. The drug pipeline
comprises eight clinical (Phase I-III) development programmes: Huntexil® for
Huntington's disease (Phase III), tesofensine for obesity (Phase III), ABT-894
for ADHD (Phase II) in partnership with Abbott, ACR343 for schizophrenia (Phase
II ready), ACR325 to treat dyskinesias in Parkinson's disease (Phase Ib),
ABT-560 for the treatment of cognitive dysfunctions (Phase I) in collaboration
with Abbott, NSD-788 for anxiety/depression (Phase I) and NSD-721 for social
anxiety disorder (Phase I). In addition, NeuroSearch has a broad portfolio of
preclinical drug candidates and holds equity interests in several biotech
companies.
