NeuroSearch A/S - Interim report for Q3 2009
16-11-09 kl. 16/11 2009 09:15 | NeuroSearch 3,50 (-0,28%)
For the entire report, please see the attached PDF file.
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Copenhagen, 16 November 2009 - Today, the Board of Directors of NeuroSearch
(NEUR) considered and approved the company's interim report for the period
1 January to 30 September 2009.
For this 9 month period, NeuroSearch reports a financial loss after tax of DKK
197.3 million (a loss of DKK 267.9 million for the same period in 2008) and
capital resources totalling DKK 703.5 million at 30 September 2009 (DKK 605.7
million at 30 September 2008).
The company maintains its financial outlook, as announced on 26 August 2009,
expecting a loss for the year ending 31 December 2009 in the region of DKK 350
million before net financial items.
On 11 November 2009, NeuroSearch announced the successful completion of a share
offering with preemptive rights to the company's existing shareholders. The
offering was subscribed 96.7%, resulting in the issue of 7,141,678 new offered
shares with a nominal value of DKK 20 each, at a price of DKK 60 per share.
After deduction of costs related to the offering, net proceeds to NeuroSearch
from the share issue total DKK 402 million (EUR 54 million), resulting in total
capital resources of more than DKK 1 billion as of 16 November 2009. During the
share offering, NeuroSearch, as required by law, divested itself of
subscription rights relating to treasury shares with total proceeds for
NeuroSearch of DKK 3.5 million.
It is management's belief that NeuroSearch, with the capital increase, has
secured the necessary financial strength to execute its strategy of:
• bringing Huntexil® (Huntington's disease) through Phase III development and
market registration before the end of 2010, with an aimed product launch in
2011 and
• progressing the product pipeline optimally, including the initiation of Phase
III development with tesofensine for the treatment of obesity.
Flemming Pedersen, CEO of NeuroSearch, commented;
“With two novel products in Phase III development, an exiting product pipeline
backed by strong partnerships and more than DKK 1 billion in capital resources
NeuroSearch holds a strong position to continue executing the offensive
strategy of transforming into a profitable specialist pharma company. With the
succesful closing of our share offering on 11 November, we are very pleased to
see that our vision is shared and backed by our shareholders.”
NeuroSearch's pipeline of drug candidates
In general, the development of NeuroSearch's pipeline of drug candidates in the
first nine months of 2009 and through the present date has been very
satisfactory.
• Huntexil® (pridopidine) - Huntington's disease: The enrolment of 437 patients
for a six month European Phase III study (the MermaiHD study), was completed in
March 2009, while enrolment in the North American study (the HART study) is
still ongoing.
The two clinical studies continue to progress satisfactorily and Huntexil® has
so far demonstrated a very promising safety profile.
More than 85% of the patients who have completed six months treatment in the
MermaiHD study, have chosen to continue treatment in a six month, open-label
extension phase. For patients, who complete the full 12 month clinical study
programme, NeuroSearch has established a compassionate use programme to allow
for continued treatment with Huntexil® on an individual basis. NeuroSearch has
decided also to offer continued treatment for the patients who complete the
HART study in the USA and Canada and with this aim the necessary preparations
are currently being undertaken.
NeuroSearch expects to disclose results from MermaiHD and HART throughout 2010,
with the first results from the six months blinded treatment in the MermaiHD
study expected in the beginning of 2010. The results from the HART study is
expected to towards mid-2010 and to be followed by the results from the six
month extension phase to MermaiHD. The company maintains its expectations of
being able to submit the first application for market registration of Huntexil®
in 2010. Preparations regarding market registration, production and marketing
are progressing according to plan.
• Tesofensine - Obesity: In June 2009, NeuroSearch held an End of Phase II
meeting with the FDA (the US Food and Drug Administration) regarding
tesofensine as a novel weight management drug. This meeting resulted in an
endorsement from the FDA of the underlying safety and efficacy package for the
drug as well as the proposed Phase III development plan. Following the
successful outcome of the FDA meeting, NeuroSearch decided to initiate one
study (TIPO-H in patients with obesity and hypertension) out of four pivotal
Phase III studies while, at the same time, continuing partnering discussions
regarding the compound. The TIPO-H study protocol has been submitted to the
FDA.
• ACR325 - Dyskinesias in Parkinson's disease: In October 2009, NeuroSearch
initiated a clinical Phase Ib study with ACR325, a dopaminergic stabiliser
having demonstrated a promising profile as a novel treatment of dyskinesias in
Parkinson's disease. Results from the study are expected in the first half of
2010 and is aimed at bridging directly into a Phase II dose-finding study.
• ACR343 - Schizophrenia: NeuroSearch is preparing to advance ACR343 into a
Phase II Proof of Concept study, evaluating the drug candidate as a novel
treatment within a specific segment of schizophrenia patients.
• NSD-721 - Social anxiety disorder: In August 2009, NeuroSearch initiated
Phase I clinical development of NSD-721 under the alliance with GlaxoSmithKline
(GSK) and in that connection, NeuroSearch received DKK 30 million (EUR 4
million) in a milestone payment and DKK 37 million (EUR 5 million) in equity
financing.
• NSD-788 - Anxiety/depression: NeuroSearch has evaluated NSD-788 in a Phase I
study and a human Proof of Mechanism PET study has been completed with positive
results. Based on these results, which support the unique profile of NSD-788 as
a novel treatment for anxiety and depression, NeuroSearch is preparing for
further development of the drug candidate towards Phase II Proof of Concept
studies.
• During the first 9 months of 2009, NeuroSearch signed two new research and
development alliances with Eli Lilly and Company (Lilly) and Janssen
Pharmaceutica (Janssen - a company under the Johnson & Johnson group),
respectively. Both alliances run for three year, focusing on separate areas for
the discovery, development and marketing of new medicines to treat diseases of
the CNS.
To date in 2009, alliance agreements have secured a total of DKK 475 million in
guaranteed revenue and financing plus attractive milestone payments and
royalties for each compound to be developed under the alliances.
Flemming Pedersen
CEO
Telephone conference
A telephone conference will be held today, 16 November 2009 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 Investor & Capital Market Relations, will present the 2009 Q3 interim report
and answer questions. The telephone conference 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 Investor & Capital Market
Relations, telephone: +45 4460 8212 or +45 4017 5103
About NeuroSearch
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 Janssen Pharmaceutica, Eli Lilly and Company and
GlaxoSmithKline (GSK), and a license collaboration with Abbott. The drug
pipeline comprises eight clinical (Phase I-III) development programmes:
Huntexil®(pridopidine) for Huntington's disease (Phase III), tesofensine for
obesity (Phase III ready), 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 partnership with GSK. In addition, NeuroSearch has a broad portfolio of
preclinical drug candidates and holds equity interests in several biotech
companies.
Forward looking statements
This announcement contains certain “forward-looking Statements”, relating to
NeuroSearch's activities and business, which can be identified by the use of
forward-looking terminology such as “estimates”, “believes”, “expects”, “may”,
“are expected to”, “will”, “should” or other similar expressions, or by
discussions of strategy, plans or intentions. Such forward-looking statements
reflect the current views of the company with respect to future events and are
based on data, assumptions and estimates that the company considers to be
reasonable. Many factors could cause the actual results, performance or
achievements of NeuroSearch to be materially different from any future results,
performances or achievements that may be expressed or implied by such
forward-looking statements. Such factors include, among others, risks
associated with product discovery and development, uncertainties related to the
performance and outcome of clinical trials, unforeseen product safety issues,
issues relating to manufacturing, market approval or acceptance of
NeuroSearch's products, competition, intellectual property issues, market
conditions and general economic conditions. Should one or more of these risks
or uncertainties materialize, or should other risks or uncertainties not
foreseen or not identified materialize or should underlying assumptions prove
incorrect, NeuroSearch's actual results may be materially and adversely
affected as compared the forward-looking statements described in this
announcement. NeuroSearch does not undertake to meet, or give any guarantee
that it will meet, the intentions or goals that may be described in this
announcement.
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