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Galapagos initiates Phase 1 trial as part of its alliance with Janssen Pharmaceutica NV

02 July 2013 at 07:30 CET

Mechelen, Belgium; 2 July 2013 - Galapagos NV (Euronext: GLPG) announced today that it has initiated a First-in-Human (FIH) Phase 1 study with GLPG1205 as part of its alliance with Janssen Pharmaceutica NV.  This achievement triggered a milestone payment of 6.6 million to Galapagos, which will contribute to H1 2013 revenues.

In 2007, Galapagos announced an alliance agreement with Janssen Pharmaceutica NV providing the option to worldwide, commercial licenses to certain Galapagos internal inflammatory disease programs.  These programs include a novel target for inflammatory disorders that was identified and validated by Galapagos using its proprietary target discovery engine.  Subsequent Galapagos research led to the discovery of GLPG1205, a first-in-class molecule that enters the clinic for inflammatory disorders.  Galapagos will be responsible for execution of Phase 1 and Phase 2A studies with GLPG1205.

"With GLPG1205, Galapagos has moved another proprietary molecule with a novel mode-of-action into the clinic.  This program has the potential to unlock a new class of drugs to treat inflammatory disorders.  Consistent with our strategy of bringing innovative molecules to the clinic, this is the fourth First-in-Human study with a novel mode-of-action," said Onno van de Stolpe, CEO of Galapagos.  "The alliance with Janssen is the second where Galapagos has brought programs from target to the clinic.  Today's achievement brings Galapagos' pipeline to five clinical programs, and we are pleased we will be driving the Phase 1 and 2A studies forward with this potential new therapy in inflammatory disease."

The aim of this FIH study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral single and multiple ascending doses of GLPG1205.  The randomized, double-blind, placebo-controlled, single center study will be conducted in 40 healthy volunteers in Belgium.  In the first part of the study, single ascending doses will be evaluated.  In the second part, the new compound will be administered daily for 14 days.  Galapagos expects to disclose topline results from the study by the end of this year.

About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action, with a large pipeline of five clinical, six pre-clinical, and 30 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications.
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 about to enter Phase 2 studies in Crohn's disease.  AbbVie and Galapagos signed a worldwide license agreement whereby AbbVie will be responsible for further development and commercialization after Phase 2B.  Galapagos has another selective JAK1 inhibitor in Phase 2 in lupus and psoriasis, GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in 2012).  GLPG0187 is a novel integrin receptor antagonist currently in a Phase 1B patient study in metastasis.  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 is currently in a First-in-Human Phase 1 study.
The Galapagos Group, including fee-for-service companies BioFocus, Argenta and Fidelta, has 800 employees and operates facilities in five countries, with global headquarters in Mechelen, Belgium.  Further information at: www.glpg.com

CONTACT

Galapagos NV
Piet Wigerinck, Chief Scientific Officer

Tel: +32 477 62 7103

Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
ir@glpg.com

Galapagos forward-looking statements
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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