Galapagos
licenses clinical rheumatoid arthritis program
Webcast
audio conference presentation 17 April 2008 on www.glpg.com
14.00 CET/8:00 AM EST, call number +32 2290 1791 or +1 866
225 8754 from US
View
webcast presentation here
Mechelen,
Belgium and Amsterdam, Netherlands; 16 April 2008 –
Galapagos NV (Euronext: GLPG) and Enceladus Pharmaceuticals
BV announce the in-licensing of Nanocort® by Galapagos.
Nanocort is a patented liposome-formulation of prednisolone
to treat inflammatory diseases, in particular for the acute
treatment of flares in rheumatoid arthritis (RA). Nanocort
is currently in a Phase I/II study. Galapagos intends to
file an Investigational New Drug (IND) application in Q1
2009, and initiate a Phase II study shortly thereafter.
Galapagos plans to seek approval as early as 2012, potentially
using shortened registration procedures. It is expected
that the license and the program costs for 2008 will not
impact Galapagos’ guidance for 2008 year end cash
position of approximately €25 million.
Nanocort
is a novel pharmaceutical, developed by Enceladus for the
treatment of acute RA flares. It is complementary to Galapagos’
present R&D program in RA that focuses on chronic treatment.
Nanocort is composed of a widely used corticosteroid enclosed
in small lipid vesicles (liposomes). Corticosteroids are
the most common treatment for RA-related flares, but their
use as a free drug is limited due to systemic side effects.
In the Nanocort treatment, the corticosteroid is confined
to the liposome in the blood stream. After injection, the
Nanocort liposomes selectively accumulate and form local
depots at sites of inflammation, from which the corticosteroid
can perform its beneficial local effects. As a result, Nanocort
should be able to significantly reduce frequency of administration
and use of the steroid compared to other therapies.
Both
the anti-inflammatory drug and the liposomes have separately
been extensively used in the clinic and have proven to be
safe. Nanocort is currently in a Phase I/II investigator-led
study in the Netherlands which will read out later this
year. Galapagos intends to file an IND application in Q1
2009, and initiate an international multi-center Phase II
study shortly thereafter. Clinquest, a product development
organization for clinical trials, will be involved in the
development of Nanocort. The primary therapeutic indication
for Nanocort will be the treatment of flares in RA, but
Galapagos will also pursue development in multiple sclerosis
and inflammatory bowel disease patients.
Under
the terms of the agreement, Galapagos will pay Enceladus
an upfront fee and run the clinical development of Nanocort.
Enceladus will receive a minority share of future revenues
received by Galapagos from the commercialization of Nanocort.
“Nanocort
provides us with a promising treatment for acute flares
in inflammatory diseases,” said Onno van de Stolpe,
Chief Executive Officer of Galapagos. “This program
rounds out our therapeutic approach for RA, encompassing
acute flare treatment through Nanocort and chronic oral
treatment with our GT418 first in class kinase program.
It contributes to our goal to build a comprehensive clinical
pipeline of risk-balanced programs in RA.”
“We
are extremely pleased with Galapagos as our development
partner for Nanocort,” commented Bart Metselaar, Chief
Executive Officer of Enceladus Pharmaceuticals. “Their
experience and commitment in rheumatoid arthritis will greatly
help in the rapid development of this exciting product.”
RA
is one of the core therapeutic areas for Galapagos drug
discovery. Galapagos’ internal candidate drug for
the treatment of chronic RA is based on kinase target GT418
and has demonstrated significant bone protection and reduced
inflammation in RA animal models. This candidate drug is
a non-steroid, novel small molecule against RA target discovered
by Galapagos and which will be developed as a first-in-class
treatment for chronic RA. Galapagos aims to file an IND
application for this candidate drug by end 2008 and to initiate
a clinical Phase I trial shortly thereafter.
Conference
call and webcast presentation
Galapagos will conduct a conference call open to the public
tomorrow, 17 April 2008, at 14.00 Central European Time
(CET)/8:00 AM US Eastern Standard Time (EST), which will
also be webcast. To participate in the conference call,
please call +32 2290 1791, or toll free in the US +1 866
225 8754, ten minutes prior to commencement. A question
and answer session will follow the presentation of the results.
The live audio webcast can be accessed via Galapagos’
website at www.glpg.com.
The archived webcast also will be available for replay shortly
after the close of the call.
View
webcast presentation here
About
RA
RA is a chronic disease, mainly affecting the joints. The
disease is characterized by inflammation of the affected
joint, which can result in chronic pain, swelling and stiffness,
and later, joint destruction and disability. RA is the most
debilitating form of arthritis and the most common inflammatory
joint disease. It is estimated that 1-2% of the population
has RA, and although it can occur at any age, onset usually
begins between the ages of 25 and 50. Women are three times
more likely than men to be affected by RA. Current market
for RA medicines is estimated at €7 billion annually
and is expected to approach €10 billion by 2012, driven
by the use of biopharmaceutical drugs. Despite the efficacy
of these drugs, patients continue to experience acute flares,
while others are not responsive. In the EU in 2006, mildly
affected RA patients received steroid treatment in 45% of
cases, moderately affected RA patients in 60% of cases,
and severely affected RA patients in 80% of cases.
About
Enceladus Pharmaceuticals
Enceladus Pharmaceuticals is a privately-owned drug development
company originating from Utrecht University, the Netherlands.
The company envisions finding inventive combinations of
drugs and drug carrier systems. Using this practical approach,
Enceladus can effectively design new prototype therapeutics
that require relatively straightforward clinical development
tracks. The company is based in Amsterdam, the Netherlands.
More information about Enceladus Pharmaceuticals can be
found at www.enceladus.nl.
About
Galapagos
Galapagos (Euronext Brussels: GLPG; Euronext Amsterdam:
GLPGA; OTC: GLPYY) is a drug discovery company with pre-clinical
programs in bone and joint diseases and bone metastasis.
Its division BioFocus DPI offers a full suite of target-to-drug
discovery products and services to pharmaceutical and biotech
companies, encompassing target discovery and validation,
screening and drug discovery through to delivery of pre-clinical
candidates. BioFocus DPI also provides adenoviral reagents
for rapid identification and validation of novel drug targets,
compound libraries for drug screening as well as chemogenomics
and ADMET database products to select targets and compounds.
Galapagos currently employs 450 people and operates facilities
in six countries, with global headquarters in Mechelen,
Belgium. More information about Galapagos can be found at
www.glpg.com.
CONTACT
Galapagos
NV
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
ir@glpg.com
This release may contain forward-looking statements,
including, without limitation, statements containing the
words “believes,” “anticipates,”
“expects,” “intends,” “plans,”
“seeks,” “estimates,” “may,”
“will,” “could,” “stands to,”
and “continues,” as well as similar expressions.
Such forward-looking statements may involve known and unknown
risks, uncertainties and other factors which might cause
the actual results, financial condition, performance or
achievements of Galapagos, or industry results, to be materially
different from any historic or future results, financial
conditions, performance or achievements expressed or implied
by such forward-looking statements. Given these uncertainties,
the reader is advised not to place any undue reliance on
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speak only as of the date of publication of this document.
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such forward-looking statements in this document to reflect
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change in events, conditions or circumstances on which any
such statement is based, unless required by law or regulation.
Nanocort
is a registered trademark of Enceladus Pharmaceuticals BV
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