NeuroSearch's associated company NsGene A/S meets important milestone with the successful Phase Ib dosing of NsG0202 in Alzheimer's patients

Investor News


NeuroSearch's associated company NsGene A/S meets important milestone with the
successful Phase Ib dosing of NsG0202 in Alzheimer's patients 

NsGene A/S, 25% owned by NeuroSearch, today announced that its novel
biodelivery product, NsG0202, has been successfully implanted into the brains
of three patients with Alzheimer's disease (AD) as part of an ongoing Phase Ib
clinical study. The Phase Ib study was initiated by NsGene in December 2007 in
collaboration with the Karolinska University Hospital in Stockholm, and after
safety and functional evaluations, an additional three Alzheimer's patients
will be implanted with NsG0202 in this year-long study. 

NsG0202 for AD is based on NsGene's proprietary and unique EC (encapsulated
cell) biodelivery platform and consists of an implantable device that secretes
nerve growth factor (NGF). NGF has shown to have neuroprotective and
regenerative effects when delivered to diseased neurons in relevant areas of
the brain. Hence, NsG0202 represents a novel treatment method for AD aimed at
restoring brain function and not only at alleviating symptoms. 

The EC biodelivery approach may constitute a breakthrough in the treatment of
severe neurological disorders, such as AD, Parkinson's disease, and epilepsy,
and  NsG0202 is the first in NsGene's pipeline of EC biodelivery products
expected to enter clinical trials over the next two years. 

Lars U. Wahlberg, Executive Vice President and COO, NsGene comments:
“This is a significant milestone for NsGene and our EC biodelivery platform and
pipeline. The successful implantation into the first three patients suffering
from Alzheimer's disease has demonstrated that the devices can be implanted
with both precision and safety and is paving the way for additional clinical
studies.” 

Flemming Pedersen, CEO of NeuroSearch comments:
“NsGene's EC biodelivery technology represents a completely novel and highly
promising approach to the treatment of neurological diseases. Today, it is only
possible to offer e.g. Alzheimer's, Parkinson's and epilepsy patients temporary
symptomatic relief, but NsGene's products hold the potential of introducing
future disease modifying neurological treatments. With the successful
implantation of NsG0202, NsGene is well ahead in proving that it is possible to
deliver biological agents into the human brain in a safe way. This is a quantum
leap forward for NsGene, and as a major shareholder in the company we are very
satisfied with their progress." 


For further information, please see attached Press release from NsGene A/S.


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. Our 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 part of the company's
activities are partner financed through a broad alliance with GlaxoSmithKline
(GSK) and collaborations with among others Abbott and Astellas. The drug
pipeline comprises 13 clinical (Phase I-III) development programmes: ACR16 in
Huntington's disease (Phase III in preparation), tesofensine in obesity (Phase
III in preparation), NS2359 in depression (Phase II) and ADHD (Phase II) in
partnership with GSK, ABT-894 in ADHD (Phase II) and pain (Phase II) in
partnership with Abbott, ACR16 in schizophrenia (Phase I) in partnership with
Astellas, ACR325 in bipolar disorder/Parkinson's disease (Phase I), ABT-107 as
well as ABT-560 for the treatment of various CNS diseases - both (Phase I) in
collaboration with Abbott, NSD-644 in pain a. o. (Phase I) in partnership with
GSK, ACR343 in Parkinson's disease (Phase I) and NSD-788 in anxiety a. o. In
addition, NeuroSearch has a broad portfolio of preclinical drug candidates and
holds equity interests in several biotech companies. 
 


Copenhagen, Denmark, April 7th, 2008

PRESS RELEASE - FOR IMMEDIATE RELEASE

Danish biotech company's restorative Alzheimer's product has successfully been
implanted in patients 

NsGene A/S today announced that its encapsulated cell (EC) biodelivery product,
NsG0202, has successfully been implanted to the brains of three patients with
Alzheimer's disease (AD). 

The NsG0202 device for AD is the first in a pipeline of EC biodelivery products
based on NsGene's proprietary platform expected to enter clinical trials for
neurological disorders over the next two years. The product is a disease
modifying implant that represents a novel treatment method aimed at restoring
brain function and not only at alleviating symptoms. Thereby, it may constitute
a breakthrough in the treatment of severe diseases of the central nervous
system, such as AD, Parkinson's disease, and epilepsy. 

The product consists of an implantable EC biodelivery device that secretes
nerve growth factor (NGF). NGF has shown to have neuroprotective and
regenerative effects when delivered to diseased neurons in relevant areas of
the brain. NsG0202 is aimed at treating the progressive dementia associated
with AD. The current phase Ib clinical trial is carried out in collaboration
with the Department of Geriatrics and Department of Neurosurgery at the
Karolinska University Hospital in Stockholm and is headed by Assoc. Prof. Maria
Eriksdotter Jönhagen, Department of Geriatrics. Three patients were
successfully implanted by the neurosurgical team headed by Prof. Bengt
Linderoth. The devices were placed at precise anatomical locations using
MRI-guided, stereotactic neurosurgery. After safety and functional evaluations,
an additional three patients will be implanted. Thus, in total, six patients
will participate in this year-long phase Ib study. 

“This is a significant milestone for NsGene and our EC Biodelivery platform and
pipeline” says Lars U. Wahlberg, Exec. Vice President and COO, NsGene. He
continues: “The successful implantation of the first three patients suffering
from Alzheimer's disease has demonstrated that the devices can be implanted
with both precision and safety and is paving the way for additional clinical
studies.” 

For further information please contact:

Lars U. Wahlberg, Executive Vice president and COO, NsGene A/S, Phone: +45 44
60 89 13, Mobile phone: +45 2360 3198, E-mail: luw@nsgene.dk 

Maria Eriksdotter Jönhagen, MD, Associate Professor, Dept. of Geriatrics,
Karolinska University Hospital, Huddinge, Phone: +46-8-58586449, mobile phone:
+46-70-560 8907, E-mail: maria.eriksdotter.jonhagen@ki.se 

Bengt Linderoth, Professor, Dept. of Neurosurgery, Karolinska University
Hospital - Solna, Phone: +46-51772592, E-mail: bengt.linderoth@karolinska.se 

Åke Seiger, Professor, Karolinska Institutet, mobile phone: +46 73 9177407.


Background on EC biodelivery device
The EC-biodelivery is a cell-based biodelivery system of protein factors to the
nervous system providing a controlled, site-specific and safe delivery of a
variety of therapeutic substances. For central nervous system (CNS)
indications, one or multiple EC biodelivery devices can be implanted in defined
regions of the brain to deliver any proteins, including growth factors,
antibodies, and neuropeptides, across the blood-brain-barrier. The proprietary
EC biodelivery system consists of a catheter-like device containing in its
active portion a genetically modified human cell line enclosed behind a
semi-permeable hollow fiber membrane. The membrane allows for the influx of
nutrients and the outflow of the therapeutic factor(s) but prevents the direct
contact between the therapeutic cells and the host tissue. The encapsulated
cells provide long-term factor secretion from the implanted device. 

EC biodelivery is a strongly and broadly patented technology platform offering
great safety advantages over direct gene therapy approaches, and technical and
functional advantages over pump technologies. 

Background on NsGene
NsGene A/S (www.nsgene.com) is a privately held Danish biotechnology company
founded in December 1999 as a spin-off from NeuroSearch A/S. NsGene develops
novel biologicals for the treat¬ment of neurological diseases. Based on the EC
biodelivery platform, NsGene develops EC biodelivery products for neurological
diseases including Alzheimer's disease, Parkinson's disease and intractable
epilepsy. In addition hereto, a number of EC biodelivery products for other
indications are under investigation. Today, NsGene employs 27 people at its
research facility located near Copenhagen in the Medicon Valley Region. For
more information, please see www.nsgene.dk.