Nanocort(R) demonstrates safety and good response in Phase I/II trial

Nanocort(R) demonstrates safety and good response in Phase I/II trial

MECHELEN, BELGIUM -- (Marketwire) -- 10/27/08 --

Results to be presented today at the 2008 American College ofRheumatology Annual Scientific Meeting in San Francisco, USA

Galapagos NV (Euronext: GLPG) announces that Nanocort has demonstratedsafety as well as a faster and more pronounced decrease in rheumatoidarthritis disease symptoms compared to reference medication. These resultswere obtained in an investigator driven double-blind, placebo controlledPhase I/II trial completed earlier this year at the RheumatologyDepartment of the Radboud University Nijmegen Medical Center in theNetherlands. The trial results will be further discussed during the "LateBreaking"poster presentation today at the 2008 American College of RheumatologyAnnual Scientific Meeting in San Francisco. Galapagosin-licensed Nanocort from Enceladus in April 2008.

The Phase I/II trial enrolled 22 patients with active rheumatoidarthritis, and its purpose was to evaluate the safety of a single,intravenous administration of Nanocort. A secondary aim of the trialwas to study the pharmacokinetics of this agent and compare thetherapeutic effect of a single, intravenous dosage of Nanocort withthat of a single intramuscular administration of an equipotent doseof the corticosteroid methylprednisolone acetate. The trial datademonstrated that Nanocort was well tolerated and had only limitedadverse events. Although the study was not powered to showsignificant effects on clinical outcomes, patients receiving Nanocortshowed faster and more pronounced decreases in disease symptoms.While therapeutic response was observed in both treatment groups,good response occurred only in patients receiving Nanocort.

"We are pleased that the Phase I/II trial results for Nanocort arepresented at an important scientific meeting organized by theAmerican College of Rheumatology, a stringent peer review body inthis indication area. The investigators report that Nanocortdemonstrated safety in this clinical trial, encouraging us toinitiate further clinical trials to explore efficacy in chronicinflammatory disease areas. Based on the data presented by theinvestigators today, Galapagos is updating its future developmentplans for Nanocort," said Onno van de Stolpe, CEO of Galapagos.

The poster presentation, "Long-circulating Liposomal Prednisoloneversus Pulse Intramuscular Methylprednisolone in Patients with ActiveRheumatoid Arthritis" - Dr Pilar Barrera, principal investigator -L10, board #453, will be held by Bart Metselaar, CEO of Enceladus, atthe 2008 American College of Rheumatology Annual Scientific Meetingin San Francisco today at 9 AM PST. The abstract, including datatable, can be found online at www.rheumatology.org/annual, Abstracts,Search 2008, Advanced Search, type "Metselaar" in author namecategory.

About Nanocort

Nanocort is a novel pharmaceutical for the treatment of RA flares andother inflammatory conditions requiring glucocorticoid therapy suchas multiple sclerosis and inflammatory bowel disease. Nanocort iscomposed of prednisolone, a widely used corticosteroid enclosed insmall lipid vesicles (liposomes). Glucocorticoids are a commontreatment for RA and many other inflammatory disorders, but their useas a free drug is limited due to systemic side effects. In theNanocort treatment, the glucocorticoid is largely confined to theliposome in the blood stream. After administration, the Nanocortliposomes selectively accumulate at sites of inflammation where theydeliver long-lasting high concentrations of glucocorticoids. As aresult, Nanocort may be able to significantly reduce frequency ofadministration and the toxicities of the glucocorticoid compared toother therapies.

About Galapagos

Galapagos (Euronext Brussels: GLPG; Euronext Amsterdam: GLPGA; OTC:GLPYY) is a drug discovery company with pre-clinical programs in boneand joint diseases and bone metastasis. Its BioFocus DPI divisionoffers a full suite of target-to-drug discovery products and servicesto pharmaceutical and biotech companies, encompassing targetdiscovery and validation, screening and drug discovery through todelivery of pre-clinical candidates. BioFocus DPI also providesadenoviral reagents for rapid identification and validation of noveldrug targets, compound libraries for drug screening as well aschemogenomics and ADMET database products to select targets andcompounds. Galapagos currently employs about 500 people and operatesfacilities in six countries, with global headquarters in Mechelen,Belgium. More information about Galapagos and BioFocus DPI can befound at www.glpg.com and www.biofocusdpi.com.

CONTACTGalapagos NVOnno van de Stolpe, CEOTel: +31 6 2909 8028ir@glpg.com

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