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Galapagos NV (GLPG.BR), GlaxoSmithKline (GSK) Anti-Inflammatory Drug Pact Hits A Roadblock


2/28/2014 9:45:45 AM

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Galapagos provides status update for GSK2586184 in GSK's psoriasis, lupus, and ulcerative colitis clinical studies

MECHELEN, Belgium, Feb. 28, 2014 (GLOBE NEWSWIRE) -- Galapagos NV (Euronext: GLPG) announced today that GSK has updated the development status for GSK2586184, involving three clinical studies in psoriasis, lupus, and ulcerative colitis.

GSK2586184 is a selective JAK1 inhibitor which was discovered and developed within Galapagos' inflammation alliance with GSK. GSK in-licensed the molecule in February 2012, gaining worldwide rights to further development and commercialization. Galapagos is eligible, without further financial investment from Galapagos, to receive from GSK up to €34M in additional milestones, plus up to double-digit royalties on global commercial sales of all therapeutic indications of GSK2586184.

All dosing of patients in the Phase 2 study in psoriasis has completed. Topline efficacy and safety results from this study are expected in the first half of 2014. Galapagos is eligible to receive a milestone payment from GSK in the event that GSK achieves a successful Proof-of-Concept in patients treated with GSK2586184. The psoriasis study was designed to recruit 64 patients, with treatment up to 12 weeks.

The Phase 2 study in systemic lupus erythematosis has been stopped at the planned first interim analysis by GSK due to a lack of effect. GSK notified Galapagos that the pre-defined stopping criteria were clearly met, triggering GSK to discontinue the lupus study with GSK2586184.

GSK has put the exploratory Phase 1/2 study in ulcerative colitis on hold. This study is designed to recruit up to 15 ulcerative colitis patients on treatment with GSK2586184.

Further details of the GSK studies with GSK2586184 can be found at www.clinicaltrials.gov.

About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action, with a large pipeline comprising of six Phase 2 studies (three led by GSK), one Phase 1 study, six pre-clinical, and 20 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications. In the field of inflammation, AbbVie and Galapagos signed a worldwide license agreement whereby AbbVie will be responsible for further development and commercialization of GLPG0634 after Phase 2B. GLPG0634 is an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, currently in Phase 2B studies in RA and in Phase 2 in Crohn's disease. Galapagos out-licensed the selective JAK1 inhibitor GSK2586184, (formerly GLPG0778) to GlaxoSmithKline in 2012. It is currently in Phase 2 for psoriasis and ulcerative colitis. GLPG0974 is the first inhibitor of FFA2 to be evaluated clinically for the treatment of IBD; this program is currently in a Proof-of-Concept Phase 2 study. GLPG1205 is a first-in-class molecule that targets inflammatory disorders and has completed Phase 1. AbbVie and Galapagos signed an agreement in CF where they work collaboratively to develop and commercialize oral drugs that address two mutations in the CFTR gene, the G551D and F508del mutation. Potentiator GLPG1837 is at the pre-clinical candidate stage. The Galapagos Group, including fee-for-service companies BioFocus, Argenta and Fidelta, has around 800 employees and operates facilities in five countries, with global headquarters in Mechelen, Belgium. Further information at: www.glpg.com

CONTACT

For media and investor inquiries:
Elizabeth Goodwin, Head of Corporate Communications & Investor Relations
Tel: +31 6 2291 6240
ir@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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