Mechelen, Belgium; 8 December 2009 – Galapagos NV (Euronext: GLPG) announced today that it has initiated clinical Phase I development of the first small molecule candidate from its arthritis alliance with GlaxoSmithKline (GSK). For entering the clinic with candidate drug GLPG0555, Galapagos receives a milestone payment of €4 million cash from 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 kinase target GT622 and was identified through Galapagos’ proprietary target discovery platform. Candidate drug GLPG0555 has demonstrated excellent activity in biochemical and animal models and has successfully completed pre-clinical development.
“This alliance with GSK was Galapagos’ first, adding a special significance to today’s clinical milestone. By funding an alliance program from target discovery to Phase I through success-based payments, we are achieving what we set out to do with our alliance strategy. This trial marks the first of what we would hope to be many programs from the arthritis alliance with GSK to enter the clinic,” said Onno van de Stolpe, Chief Executive Officer of Galapagos.
With the initiation of the Phase I trial with GLPG0555, Galapagos now has four candidate drugs in clinical development (Phase I and Phase II).
Details of the Phase I clinical trial
The primary endpoints of this first-in-human trial will be to determine the safety, tolerability, and pharmacokinetics of the candidate drug GLPG0555. The double blind, single ascending and multiple dose studies will be conducted in 34 healthy human volunteers in Belgium over the coming months.
About Galapagos’ arthritis alliance with GlaxoSmithKline
GSK and Galapagos initiated an arthritis alliance to discover and develop disease-modifying drugs for GSK’s global R&D organization in June 2006. In July 2007 and December 2008, GSK and Galapagos expanded the alliance to include additional targets. GSK has an exclusive option to further develop and commercialize these compounds on a worldwide basis.
Galapagos (Euronext: GLPG; OTC: GLPYY) is a drug discovery and development company with small molecule programs in bone and joint diseases, bone metastasis, cachexia, anti-infectives and metabolic diseases. It has established risk sharing alliances with GSK, Janssen Pharmaceutica, Eli Lilly and Merck and Co. Through an alliance with MorphoSys, Galapagos is also developing new antibody therapies in bone and joint diseases. Its division BioFocus offers a full suite of target-to-drug discovery products and services to pharmaceutical and biotech companies and to patient foundations, encompassing target discovery and validation, screening and drug discovery through to delivery of pre-clinical candidates. Galapagos currently employs 495 people and operates facilities in six countries, with global headquarters in Mechelen, Belgium. More info at: www.glpg.com.
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
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.