Mechelen, Belgium;
23 February 2010 – Galapagos NV (Euronext: GLPG) announced
today that it has completed Phase I clinical trials for
GLPG0259, a novel mechanism-of-action candidate drug being
developed for rheumatoid arthritis (RA). These results support
the design of a Phase II study planned to start later this
year, where the efficacy of the novel candidate drug will
be assessed in RA patients. Galapagos will present detailed
results of GLPG0259 and other programs during an R&D
Update scheduled for 19 March 2010.
The Phase I studies for
GLPG0259 have shown a good safety profile in healthy volunteers
and confirm a once-daily oral dosing regimen. Furthermore,
the studies have confirmed the feasibility of combining
GLPG0259 with methotrexate (the current standard treatment
for RA) in future trials. A similar safety and PK profile
was observed for the capsule formulation of GLPG0259, which
will be used in the Phase II efficacy trial in RA patients
scheduled to begin in the third quarter of 2010.
“This latest clinical
study further demonstrated the safety and once-daily dosing
of GLPG0259 in healthy volunteers and sets us on course
to initiate an extended trial in rheumatoid arthritis patients,”
said Onno van de Stolpe, CEO of Galapagos. “We are
very pleased with how this program is progressing and excited
that we are on track to start the assessment of the first
Galapagos-based candidate drug in patients later this year.”
About Galapagos’ R&D update and webcast
presentation
Galapagos invites analysts, investors and journalists to
attend an R&D update meeting in which an overview of
the Company’s clinical and pre-clinical pipeline progress
will be given. The meeting will take place at Galapagos’
Paris research site, located at 102 Avenue Gaston Roussel
93230 Romainville, France, starting at 13.00 CET on 19 March
2010.
Galapagos management will
present the R&D strategy, the latest information on
Galapagos’ discovery and development programs and
an update to its clinical and pre-clinical portfolio. Those
who wish to attend the meeting in person should confirm
their attendance via email to ir@glpg.com.
Galapagos will also hold
a conference and live audio webcast of this meeting starting
at 13.00 CET on 19 March 2010. Click
here to access the live audio webcast. To participate
in the conference call, please call +32 2290 1791
ten minutes prior to commencement. A question and answer
session will follow the presentation of the results. The
archived webcast also will be available for replay shortly
after the live presentation.
About MAPKAPK5 and candidate drug GLPG0259
Target MAPKAPK5 is a new starting point for the treatment
of rheumatoid arthritis (RA). Galapagos discovered and validated
the key role of this target in the RA disease process, using
its proprietary target discovery technology. MAPKAPK5 had
not been previously associated with RA; however, Galapagos
has shown that it plays a key role in inflammation and in
the breakdown of collagen in human cartilage. The candidate
drug GLPG0259 inhibits MAPKAPK5 in human cells, and demonstrates
excellent bone protection and reduced inflammation in a
standard RA animal model.
GLPG0259 is a novel mechanism-of-action
inhibitor of the protein kinase MAPKAPK5. It is a compound
in Galapagos’ internal RA program, which is part of
an option agreement with Janssen Pharmaceutica. Upon the
completion of a dose finding Phase II clinical trial for
GLPG0259, Janssen has the exclusive option to license the
program for €60 million, with further potential milestones
to Galapagos of €776 million and up to double-digit
royalties on global sales.
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size biotechnology
company specialized in the discovery and development of
small molecule and antibody therapies with novel modes-of-action.
The Company is progressing one of the largest pipelines
in biotech, with four clinical and over 40 small molecule
discovery/pre-clinical programs. Through risk/reward-sharing
alliances with GlaxoSmithKline, Eli Lilly, Janssen Pharmaceutica,
Merck & Co. and Roche, Galapagos is eligible to receive
up to €3 billion in downstream milestones, plus royalties.
Together with the service operations of BioFocus and Argenta,
Galapagos now has more than 640 employees 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
Elizabeth Goodwin, Director
Investor Relations
Tel: +31 6 2291 6240
ir@glpg.com
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