MECHELEN, BELGIUM--(Marketwire - January 05, 2009) - Galapagos NV (Euronext: GLPG)
announced today that it has successfully achieved a pre-clinical
candidate drug in its osteoarthritis alliance with GlaxoSmithKline
(GSK). Galapagos also reached milestones on other compounds in the
alliance, triggering payments totaling EUR 7.6 million to Galapagos. To
date, Galapagos has earned a total of EUR 25.5 million in payments from
GSK under this alliance.
The pre-clinical candidate drug is a small molecule that meets all
the chemical and biological criteria set by GSK for a potential new
drug. The candidate was developed by Galapagos against a novel
target discovered with Galapagos' proprietary platform. The molecule
is now ready for scale up chemistry and comprehensive safety
evaluation, with the aim to enter the clinical research phase within
a 12-month time frame.
In June 2006, GSK and Galapagos initiated a program to discover and
develop disease-modifying drugs for GSK's global R&D organization.
Through the agreement, Galapagos broadened its drug discovery
portfolio in the field of osteoarthritis, with the aim to develop
candidate drugs through to successful Proof of Concept in clinical
research Phase IIa. GSK has exclusive options to further develop and
commercialize these compounds on a worldwide basis. In July 2007,
GSK and Galapagos signed an expansion to include two selected GSK
targets. In December 2008, the companies further broadened the scope
of the alliance through the inclusion of two more drug targets.
"Today's announced milestones are strong evidence of Galapagos'
ability to deliver consistently on its alliances," said Onno van de
Stolpe, Chief Executive Officer of Galapagos. "In the osteoarthritis
alliance with GSK we have moved from target to a pre-clinical
candidate drug in less than 2.5 years for the lead program and have
multiple additional compounds in progress. With this broad portfolio
of compounds, the alliance is well positioned to deliver
disease-modifying drug candidates to GSK."
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 aging 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 arthritis 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 target to pre-clinical drug candidate in less than 2.5
years, in this challenging area where there are currently no marketed
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 ADMET
products to select compounds. Galapagos currently employs 460 people
and operates facilities in six countries, with global headquarters in
Mechelen, Belgium. More information about Galapagos can be found at
Galapagos' alliance strategy
Through its risk sharing alliances with big pharma, Galapagos is
eligible to receive in excess of EUR 1.7 billion in success-dependent
milestone payments plus double-digit royalties on the worldwide sales
of medicines that may result from these programs. These payments
contribute to the expansion of Galapagos' R&D to over 30 programs in
bone and joint disease. The first alliance program based on a novel
Galapagos target is scheduled to enter Phase I clinical trials in
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 such forward-looking
statements. These forward-looking statements speak only as of the
date of publication of this document. Galapagos expressly disclaims
any obligation to update any such forward-looking statements in this
document to reflect any change in its expectations with regard
thereto or any change in events, conditions or circumstances on which
any such statement is based, unless required by law or regulation.
 Galapagos estimates based on Datamonitor Market Research, "Global
Overview Arthritis," January 2004
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