• First program
from GSK arthritis alliance to reach clinic
• Based on kinase target identified through Galapagos’
target discovery platform
• Galapagos receives €4 M milestone payment from
GSK
Mechelen, Belgium;
8 December 2009 – Galapagos NV (Euronext: GLPG) announced
today that it has initiated clinical Phase I development
of the first small molecule candidate from its arthritis
alliance with GlaxoSmithKline (GSK). For entering the clinic
with candidate drug GLPG0555, Galapagos receives a milestone
payment of €4 million cash from GSK. Since the start
of the arthritis alliance in June 2006, Galapagos has received
a total of €35 million in payments from GSK.
The orally-available, novel candidate drug GLPG0555 modifies
kinase target GT622 and was identified through Galapagos’
proprietary target discovery platform. Candidate drug GLPG0555
has demonstrated excellent activity in biochemical and animal
models and has successfully completed pre-clinical development.
“This alliance with GSK was Galapagos’ first,
adding a special significance to today’s clinical
milestone. By funding an alliance program from target discovery
to Phase I through success-based payments, we are achieving
what we set out to do with our alliance strategy. This trial
marks the first of what we would hope to be many programs
from the arthritis alliance with GSK to enter the clinic,”
said Onno van de Stolpe, Chief Executive Officer of Galapagos.
With the initiation of the Phase I trial with GLPG0555,
Galapagos now has four candidate drugs in clinical development
(Phase I and Phase II).
Details of the Phase I clinical trial
The primary endpoints of this first-in-human trial will
be to determine the safety, tolerability, and pharmacokinetics
of the candidate drug GLPG0555. The double blind, single
ascending and multiple dose studies will be conducted in
34 healthy human volunteers in Belgium over the coming months.
About Galapagos’
arthritis alliance with GlaxoSmithKline
GSK and Galapagos initiated an arthritis alliance to discover
and develop disease-modifying drugs for GSK’s global
R&D organization in June 2006. In July 2007 and December
2008, GSK and Galapagos expanded the alliance to include
additional targets. GSK has an exclusive option to further
develop and commercialize these compounds on a worldwide
basis.
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is a drug discovery
and development company with small molecule programs in
bone and joint diseases, bone metastasis, cachexia, anti-infectives
and metabolic diseases. It has established risk sharing
alliances with GSK, Janssen Pharmaceutica, Eli Lilly and
Merck and Co. Through an alliance with MorphoSys, Galapagos
is also developing new antibody therapies in bone and joint
diseases. Its division BioFocus offers a full suite of target-to-drug
discovery products and services to pharmaceutical and biotech
companies and to patient foundations, encompassing target
discovery and validation, screening and drug discovery through
to delivery of pre-clinical candidates. Galapagos currently
employs 495 people and operates facilities in six countries,
with global headquarters in Mechelen, Belgium. More info
at: www.glpg.com.
CONTACT
Galapagos
NV
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
ir@glpg.com
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