Galapagos
announces milestone payment of €0.8 million in osteoarthritis
alliance with GlaxoSmithKline
Mechelen,
Belgium; 16 June 2008 – Galapagos NV (Euronext: GLPG)
announced today that it has reached two new milestones in
its multi-year drug discovery alliance with GlaxoSmithKline
in osteoarthritis, triggering a payment of €0.8 million
from GSK.
In
June 2006, GSK’s Center of Excellence for External
Drug Discovery (CEEDD) and Galapagos initiated a program
to deliver disease-modifying drugs with clinical Proof of
Concept to GSK’s global research and development organization.
The aim of this agreement is for Galapagos to expand its
portfolio of novel targets in the field of osteoarthritis,
to conduct compound screening, identify tractable hits,
pursue a number of hit-to-lead programs, and develop the
resulting leads into candidate selection compounds through
to a successful Proof of Concept in clinical research Phase
IIa. GSK has exclusive options to further develop and commercialize
these compounds on a worldwide basis. Galapagos will have
the right to further develop and commercialize compounds
for which GSK does not exercise its option. In July 2007,
GSK made a €4.4 million equity investment in Galapagos
and the alliance was expanded to include up to two selected
GSK targets. Now part of GSK’s Immunoinflammation
Center of Excellence for Drug Discovery alliance portfolio,
the expanded alliance is worth up to €186 million in
milestones for two marketable products to Galapagos, plus
royalties on global product sales.
Today’s
announcement marks the fifth milestone payment made to Galapagos
since the start of the osteoarthritis alliance. To date,
Galapagos has received a total of €15.9 million in
access fees and milestone payments from GSK under the alliance.
“We
are pleased that the osteoarthritis alliance with GSK is
progressing as planned, in line with our expectation to
deliver a pre-clinical candidate this year,” said
Onno van de Stolpe, Chief Executive Officer of Galapagos.
“Our successful track record in risk-sharing alliances
demonstrates that this model is a viable strategy to progress
a number of drug discovery programs while retaining the
upside.”
Commenting
on the collaboration, Jose Carlos Gutierrez-Ramos, Ph.D.,
Senior Vice President and head of the Immuno-Inflammation
Center of Excellence for Drug Discovery at GSK noted “Galapagos
is proving to be a partner which consistently delivers results.
We are confident that our alliance will continue to advance
GSK’s pipeline in osteoarthritis.”
About
osteoarthritis
Osteoarthritis (OA) is the most common form of arthritis,
typically affecting people aged 45 and older. It is a degenerative
disease characterized by joint destruction and loss of articular
cartilage. Cartilage is the slippery tissue that covers
the ends of bones in a joint. Healthy cartilage allows bones
to glide over one another. It also absorbs energy from the
shock of physical movement. In OA, the surface layer of
cartilage breaks down and wears away. This allows bones
under the cartilage to rub together, causing pain, swelling,
and loss of motion of the joint. Over time, the joint may
lose its normal shape. Also, bone spurs - small growths
called osteophytes - may grow on the edges of the joint.
Bits of bone or cartilage can break off and float inside
the joint space. This causes more pain and damage. No currently
available treatments prevent OA or even reverse or block
the disease process. Treatment of OA involves pain control,
weight control, and exercise. Many OA patients have pain
that persists despite these measures. Most of these patients
use non-steroidal anti-inflammatory drugs (NSAIDs) that
relieve the symptoms without changing the course of the
underlying disease. Healthcare providers are concerned about
long-term NSAID use due to serious possible side effects.
It is expected that with the ageing of the population, more
individuals will be prone to develop OA. As mobility of
seniors is of high importance to maintaining a high quality
of life, preventing the severity of OA is seen as an immense
clinical need over the next decade. The market potential
of a disease-modifying drug could exceed $8 billion annually
, based on the current market and the absence of disease-modifying
treatment.
Galapagos’
osteoarthritis program
Galapagos focuses its osteoarthritis research programs on
chondrocytes, the main cell types in cartilage. These programs
will be the basis of the alliance with GSK. Galapagos has
identified a number of novel targets that have been validated
in cellular disease models and has progressed these into
drug discovery. Modulation of these targets in human chondrocytes
should lead to a net production of stable cartilage and
should therefore be able to prevent and repair damage to
this cartilage in patients.
In
February 2008, Galapagos announced achievement of a Proof
of Principle (reduction of a disease marker) and Proof of
Concept (reduction of targeted symptoms) in pre-clinical
models in its osteoarthritis (OA) program. Galapagos compounds
block cartilage degradation in diseased cartilage explants,
while diseased mouse joints treated with this compound also
showed reduced cartilage destruction. Galapagos’ osteoarthritis
program has progressed from validated targets to a Proof
of Principle in 18 months, in this challenging area where
there are currently no marketed disease-modifying drugs.
The data generated thus far encourage Galapagos to aim for
delivery of a pre-clinical candidate in OA by end 2008.
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 460 people and operates facilities
in six countries, with global headquarters in Mechelen,
Belgium. More information about Galapagos and BioFocus DPI
can be found at www.glpg.com
and www.biofocusdpi.com.
About GlaxoSmithKline
GlaxoSmithKline, one of the world's leading research-based
pharmaceutical and healthcare companies, is committed to
improving the quality of human life by enabling people to
do more, feel better and live longer. For information about
GlaxoSmithKline visit the company website at www.gsk.com.
About the Immuno-Inflammation Center of Excellence
for Drug Discovery (II-CEDD)
GlaxoSmithKLine’s Immuno-Inflammation Centre of Excellence
for Drug Discovery is dedicated to discovering therapies
for inflammatory diseases. It is designed to integrate and
better coordinate the progression of inflammatory disease
medicines from therapeutic hypothesis to clinical proof
of concept. It focuses on building an innovative pipeline
through both internal efforts and external alliances with
other companies and research institutions and will focus
on 'virtualising' a portion of the inflammatory diseases
pipeline by forming multiple risk-sharing/reward-sharing
alliances.
CONTACT
Galapagos NV
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
ir@glpg.com
1
Galapagos estimates based on Datamonitor Market Research,
“Global Overview Arthritis,” January 2004
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