Galapagos receives ?4 M milestone for first clinical trial in
GlaxoSmithKline alliance
(Thomson Reuters ONE) - * First program from GSK arthritis alliance to reach clinic* Based on kinase target identified through Galapagos' target discovery platform* Galapagos receives ?4 M milestone payment from GSKMechelen, Belgium; 8 December 2009 - Galapagos NV (Euronext: GLPG)announced today that it has initiated clinical Phase I development ofthe first small molecule candidate from its arthritis alliance withGlaxoSmithKline (GSK). For entering the clinic with candidate drugGLPG0555, Galapagos receives a milestone payment of ?4 million cashfrom GSK. Since the start of the arthritis alliance in June 2006,Galapagos has received a total of ?35 million in payments from GSK.The orally-available, novel candidate drug GLPG0555 modifies kinasetarget GT622 and was identified through Galapagos' proprietary targetdiscovery platform. Candidate drug GLPG0555 has demonstratedexcellent activity in biochemical and animal models and hassuccessfully completed pre-clinical development."This alliance with GSK was Galapagos' first, adding a specialsignificance to today's clinical milestone. By funding an allianceprogram from target discovery to Phase I through success-basedpayments, we are achieving what we set out to do with our alliancestrategy. This trial marks the first of what we would hope to bemany programs from the arthritis alliance with GSK to enter theclinic," said Onno van de Stolpe, Chief Executive Officer ofGalapagos.With the initiation of the Phase I trial with GLPG0555, Galapagos nowhas four candidate drugs in clinical development (Phase I and PhaseII).Details of the Phase I clinical trialThe primary endpoints of this first-in-human trial will be todetermine the safety, tolerability, and pharmacokinetics of thecandidate drug GLPG0555. The double blind, single ascending andmultiple dose studies will be conducted in 34 healthy humanvolunteers in Belgium over the coming months.About Galapagos' arthritis alliance with GlaxoSmithKlineGSK and Galapagos initiated an arthritis alliance to discover anddevelop disease-modifying drugs for GSK's global R&D organization inJune 2006. In July 2007 and December 2008, GSK and Galapagosexpanded the alliance to include additional targets. GSK has anexclusive option to further develop and commercialize these compoundson a worldwide basis.About GalapagosGalapagos (Euronext: GLPG; OTC: GLPYY) is a drug discovery anddevelopment company with small molecule programs in bone and jointdiseases, bone metastasis, cachexia, anti-infectives and metabolicdiseases. It has established risk sharing alliances with GSK,Janssen Pharmaceutica, Eli Lilly and Merck and Co. Through analliance with MorphoSys, Galapagos is also developing new antibodytherapies in bone and joint diseases. Its division BioFocus offers afull suite of target-to-drug discovery products and services topharmaceutical and biotech companies and to patient foundations,encompassing target discovery and validation, screening and drugdiscovery through to delivery of pre-clinical candidates. Galapagoscurrently employs 495 people and operates facilities in sixcountries, with global headquarters in Mechelen, Belgium. More infoat: www.glpg.com.CONTACTGalapagos NVOnno van de Stolpe, CEOTel: +31 6 2909 8028ir(at)glpg.comThis 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 assimilar expressions. Such forward-looking statements may involveknown and unknown risks, uncertainties and other factors which mightcause the actual results, financial condition, performance orachievements of Galapagos, or industry results, to be materiallydifferent from any historic or future results, financial conditions,performance or achievements expressed or implied by suchforward-looking statements. Given these uncertainties, the reader isadvised not to place any undue reliance on such forward-lookingstatements. These forward-looking statements speak only as of thedate of publication of this document. Galapagos expressly disclaimsany obligation to update any such forward-looking statements in thisdocument to reflect any change in its expectations with regardthereto or any change in events, conditions or circumstances on whichany such statement is based, unless required by law or regulation.This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 08.12.2009 - 07:30 Uhr
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