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Galapagos NV (GLPG.BR) to Present GLPG0634 Phase II POC Results at EULAR


6/5/2012 8:57:32 AM

MECHELEN, BELGIUM--(Marketwire - June 05, 2012) - Galapagos NV (EURONEXT BRUSSELS: GLPG) announced today that it will give an oral presentation on 9 June 2012 at the EULAR Annual European Congress of Rheumatology. Galapagos will present the results from the Phase II Proof of Concept study for GLPG0634, a selective inhibitor of Janus kinase 1 (JAK1), in rheumatoid arthritis patients.

The Proof of Concept results for GLPG0634 will be presented Saturday at The European League Against Rheumatism (EULAR) taking place 6 to 9 June 2012 in Berlin:

Efficacy and Safety of GLPG0634, a Selective JAK1 Inhibitor, after Short-term Treatment of Rheumatoid Arthritis; Results of a Phase IIa Trial (9 June, 9:50 - 10:00 AM, Hall 1.1)

The presented data demonstrate that GLPG0634 is highly active with a rapid onset of action and a very good safety profile when given for 28 days to patients with moderate to severe rheumatoid arthritis, insufficiently controlled by methotrexate alone.

The full abstract can be accessed through the EULAR conference website: www.eular.org

Details of the Phase II clinical study

The clinical Proof of Concept Phase II study for GLPG0634 involved 36 patients with active rheumatoid arthritis, showing an insufficient response to the standard-of-care treatment, methotrexate (MTX). The aim of this study was to evaluate the efficacy and safety of GLPG0634 in patients with active rheumatoid arthritis. Three groups of 12 patients with moderate to severe disease received either a 200 mg once-daily or a 100 mg twice-daily dose regimen of GLPG0634 or placebo, for a period of four weeks, while continuing to take their stable background therapy of MTX and other low-dose anti-inflammatory drugs. The primary efficacy endpoint was the ACR20 response rate, the standard primary endpoint for early RA clinical studies. Secondary endpoints included improvements in ACR50, ACR70 and DAS28 rates. The safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG0634 in RA patients were also evaluated.

About candidate drug GLPG0634

GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitor with selectivity for JAK1 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 studies with an early onset of action. GLPG0634 differentiates from other JAK inhibitors in development by specifically targeting JAK1, a strategy which could result in a better efficacy and safety profile. GLPG0634 is a fully proprietary program. Upon successful completion of the RA Phase IIb studies, Abbott will license the program and will assume sole responsibility for Phase III clinical development and global manufacturing.

About EULAR

The annual EULAR congresses are a major event in the calendar of world rheumatology. The aim is to provide a forum of the highest standard for scientific (both clinical and basic), educational and social exchange between professionals involved in rheumatology, liaising with patient organisations, in order to achieve progress in the clinical care of patients with rheumatic diseases. More info at: www.eular.org

About Galapagos

Galapagos (EURONEXT BRUSSELS: GLPG) (PINKSHEETS: 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 four 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

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.

This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that:

(i) the releases contained herein are protected by copyright and other applicable laws; and

(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Galapagos NV via Thomson Reuters ONE

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CONTACT

Galapagos NV
Piet Wigerinck
CSO
Tel: +32 477 62 7103

Elizabeth Goodwin
Director Investor Relations
Tel: +31 6 2291 6240
Email Contact


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