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Galapagos Initiates Phase I Study for JAK Inhibitor GLPG0634, Acquires Full Rights to Compound From GSK

Aug. 06, 2010
 Galapagos NV (Euronext: GLPG) announced today that it has acquired from GlaxoSmithKline (GSK) the full rights to GLPG0634, a small molecule drug previously part of the Company's arthritis alliance with GSK. Galapagos is initiating a Phase I clinical trial with this selective JAK inhibitor.

GLPG0634 is an orally-available, novel candidate drug developed by Galapagos and selective against Janus kinase (JAK) 1 and 2 targets discovered in collaboration with GSK. GLPG0634 has demonstrated excellent activity in biochemical studies and in vivo models of rheumatoid arthritis, and has successfully completed pre-clinical development. Galapagos has received regulatory and ethical committee approval to initiate Phase I clinical studies for GLPG0634 and plans to begin dosing in healthy volunteers on Monday August 9, 2010.

Candidate drug GLPG0634 was formally part of Galapagos' arthritis alliance with GSK. Galapagos re-acquired the rights to GLPG0634 from GSK for an undisclosed amount and will initiate clinical development of this candidate without any further involvement from GSK. In a Phase I clinical study, Galapagos is investigating the safety and pharmacological profile of GLPG0634. Galapagos aims to maximize the value of GLPG0634 before seeking a partner for development.

"JAK inhibitors have shown great efficacy in rheumatoid arthritis trials recently. GLPG0634 has a competitive therapeutic profile and we believe that this is an attractive compound to take into development," said Onno van de Stolpe, CEO of Galapagos. "We are pleased that we have been able to acquire the rights to the molecule from GSK, and we look forward to the results of the clinical study, with the aim to out-license the program at a later stage."

Details of the GLPG0634 first-in-human Phase I clinical trial

The primary endpoints of this first-in-human trial will be to determine the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profile of the candidate drug GLPG0634. The double blind, placebo-controlled single and multiple ascending dose study will be conducted in at least 40 healthy human volunteers in Belgium over the coming months.

About JAKs

There are four known JAK enzymes: JAK1, 2, 3 and TYK2. These enzymes are critical components of signaling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in rheumatoid arthritis patients. Pathways triggered by the JAKs are dysregulated in inflammation, myeloproliferative diseases, and other liquid and solid cancers.
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 50 small molecule discovery/pre-clinical programs. Through risk/reward-sharing alliances with GlaxoSmithKline, Eli Lilly, Janssen Pharmaceutica, Merck & Co., Roche and Servier. Galapagos is eligible to receive EUR3.3 billion in downstream milestones, plus royalties. Together with its BioFocus and Argenta service operations, Galapagos has over 680 employees and operates facilities in six countries, with global headquarters in Mechelen, Belgium. More info at: www.glpg.com