Galapagos Achieves Clinical Proof-of-Mechanism Milestone in GSK Alliance

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 EUR single-digit millions payment to Galapagos. 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. "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 EUR200 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 EUR64 million in payments from GSK.