Galapagos achieves clinical Proof-of-Mechanism milestone in GSK alliance
(Thomson Reuters ONE) -
   ·        GLPG0778 shows statistically significant and selective effects on
biomarkers in healthy volunteers
   ·        Further information available on safety, tolerability and dosing
profile
   ·        Galapagos receives ? single-digit millions milestone payment
Mechelen, Belgium; 19 December 2011 - Galapagos NV (Euronext: GLPG) announced
today that investigational medicine GLPG0778, which is part of its immuno-
inflammatory alliance with GlaxoSmithKline, has shown selective effects on a
biomarker in a Phase I Proof-of-Mechanism study in healthy volunteers. The
study also provided information on the safety and pharmacokinetic (PK) profile
of GLPG0778.
Galapagos conducted the Phase I study in 45 healthy volunteers divided into 5
cohorts, receiving in total 4 different dosages for 2 weeks. GPLG0778 showed
dose-dependent, statistically-significant and selective suppression of an
induced inflammatory response in the volunteers, indicating specific inhibition
of the medicine's target in vivo. In addition to measuring the biomarker
response, the study also provided information on the safety, tolerability and PK
of GLPG0778. GSK has determined that these results meet the criteria of
clinical Proof of Mechanism, thereby triggering a ? single-digit millions
payment to Galapagos. Â GSK now has 90 days to evaluate these results and
determine whether to exercise its exclusive option to in-license GLPG0778 and
its corresponding back-up compounds, including GLPG0555.
"GLPG0778 is Galapagos' second candidate drug to show targeted activity in
clinical trials this year and our first alliance program to deliver clinical
Proof-of Mechanism results," said Onno van de Stolpe, CEO of Galapagos. Â "We
believe GLPG0778's biomarker and safety profile support its further development
in a Phase II clinical study in a patient population."
About Galapagos' immuno-inflammation alliance with GlaxoSmithKline
Galapagos and GSK initiated an alliance to discover and develop disease-
modifying drugs for GSK's global R&D organization in June 2006. Subject to
achievement of certain milestone events Galapagos has the potential to receive
more than ?200 million in total milestone payments, plus up to double-digit
royalties from GSK. GSK has an exclusive option to further develop and
commercialize compounds from the alliance on a worldwide basis. Since the start
of the immuno-inflammation alliance, Galapagos has received more than ?64
million in payments from GSK.
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 GLPG0634, as
well as one of the largest pipelines in biotech, with seven programs in
development and over 50 discovery programs. The Galapagos Group has about 800
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(at)glpg.com
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Source: Galapagos NV via Thomson Reuters ONE
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