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GLPG0634 single center Proof of Concept results to be presented at American College of Rheumatology Annual meeting

MECHELEN, BELGIUM -- (Marketwire) -- 11/11/12 -- Galapagos NV (EURONEXT BRUSSELS: GLPG) announced today that the single center Proof of Concept results from 2011 in rheumatoid arthritis with selective JAK1 inhibitor GLPG0634 will be presented during the American College of Rheumatology (ACR) Annual meeting in Washington, D.C. Furthermore, the Company will present a poster on Phase I results with excellent safety at higher doses of GLPG0634, showing that no maximum tolerated dose was reached. The oral presentation will form part of the session entitled: "Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy: Safety & Efficacy of Janus Activated-Kinase (JAK) Inhibitors." The presentation will highlight the differentiated safety and efficacy profile of GLPG0634 in 36 rheumatoid arthritis patients treated for 28 days in a single center study in Moldova:

Selective JAK1 Inhibition in the Treatment of Rheumatoid Arthritis: Proof of Concept with GLPG0634 (13-Nov, 3:30 PM, Ballroom C, Abstract #2489)

The poster data demonstrate that GLPG0634 shows selective JAK1 inhibition, good safety and maintained JAK1-related biomarker response for up to 10 days after dosing of 300 mg and 450 mg in healthy volunteers. Biomarker data also show that JAK1 is inhibited throughout the day for once-daily dosing of GLPG0634 in healthy volunteers. As 450 mg is the highest dose ever investigated, no maximum tolerated dose for GLPG0634 was attained:

Once Daily Higher Dose Regimens of GLPG0634 in Healthy Volunteers Are Safe and Provide Continuous Inhibition of JAK1 but not JAK2 (12-Nov, 9:00 AM - 6:00 PM, Poster Hall B, Abstract #1331) The full abstracts can be accessed through the ACR website. The poster will be available in PDF format on Galapagos' website: www.glpg.com.

About candidate drug GLPG0634

GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitor with selectivity for JAK1 currently in Phase II and being developed by Galapagos. JAKs are critical components of signaling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in rheumatoid arthritis patients. JAK inhibitors have shown long-term efficacy in rheumatoid arthritis trials with an early onset of action. Galapagos aims to differentiate GLPG0634 from other JAK inhibitors in development by specifically targeting JAK1, a strategy which could result in a cleaner safety profile.

About Galapagos

Galapagos (EURONEXT BRUSSELS: GLPG) (PINKSHEETS: GLPYY) is a mid-size clinical stage biotechnology company specialized in the discovery and development of small molecule and antibody therapies with novel modes-of-action. The Company is progressing its JAK1 inhibitor GLPG0634, as well as one of the largest pipelines in biotech, with four programs in development and over 30 discovery programs. The Galapagos Group has over 800 employees and operates facilities in six countries, with global headquarters in Mechelen, Belgium. More info at: www.glpg.com

This release may contain forward-looking statements, including, without limitation, statements containing the words "believes," "anticipates," "expects," "intends," "plans," "seeks," "estimates," "may," "will," "could," "stands to," and "continues," as well as similar expressions. Such forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless required by law or regulation.

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Source: Galapagos NV via Thomson Reuters ONE

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Galapagos NV
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