Mechelen, Belgium; 11 January 2011 - Galapagos NV (Euronext: GLPG) announced today progress achieved in its arthritis alliance with GlaxoSmithKline (GSK). Galapagos completed first-in-human trials with GLPG0555 in healthy volunteers. Galapagos also initiated clinical Phase I development for a second candidate drug, GLPG0778, which triggered a milestone payment of €7.4 million.
Initial Phase I results for the first candidate drug in the alliance, GLPG0555, showed no changes in vital signs and laboratory parameters for dosing up to 14 consecutive days in healthy volunteers. GLPG0555 was well tolerated with no severe adverse events reported.
In late December 2010, Galapagos initiated a first-in-human trial for GLPG0778, which is being conducted in healthy volunteers over the coming months. This second candidate drug, which inhibits kinase target GT623, has demonstrated excellent activity and safety in biochemical and animal models, and has successfully completed pre-clinical development.
"We are pleased to report progress on candidate drugs in our arthritis alliance with GSK," said Onno van de Stolpe, CEO of Galapagos. "Today's announcement increases our clinical rheumatoid arthritis portfolio to four candidate drugs, with a balanced risk profile of known and novel modes of action."
Details of GLPG0555 Phase I clinical trials
The primary endpoints of the first-in-human trials were to determine the safety, tolerability and PK profile of candidate drug GLPG0555. The double-blind, single ascending and multiple dose studies were conducted in 35 healthy human volunteers.
A double-blind, multiple ascending dose study for GLPG0555 is currently being conducted in up to 40 healthy human volunteers to further assess the safety, PK and biomarker profile. Furthermore, Galapagos is preparing to investigate a novel capsule formulation for later stage trials.
Details of GLPG00778 first-in-human trial
The primary endpoints of the first-in-human trial for GLPG0778 will be to determine the safety, tolerability and PK. The secondary endpoint will be to explore biomarker effects of this candidate drug. The placebo-controlled, double-blind, single ascending and multiple dose studies are being conducted in 40 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. GSK and Galapagos expanded the alliance on three occasions to include additional targets and increase the number of programs. Following the latest expansion in December 2009, Galapagos is eligible to receive more than €200 million in milestones, plus up to double-digit royalties from GSK. GSK has an exclusive option to further develop and commercialize these compounds on a worldwide basis. Since the start of the arthritis alliance, Galapagos has received a total of €54.7 million in payments from GSK.
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size biotechnology company specialized in the discovery and development of small molecule and antibody therapies with novel modes-of-action. The Company is progressing one of the largest pipelines in biotech, with seven clinical and over 50 discovery programs. Through risk/reward-sharing alliances with GlaxoSmithKline, Lilly, Janssen Pharmaceutica, Merck & Co., Roche and Servier, Galapagos is eligible to receive up to €3.3 billion in downstream milestones, plus royalties. The Galapagos Group has over 800 employees and operates facilities in seven countries, with global headquarters in Mechelen, Belgium. More info at: www.glpg.com
CONTACT
Galapagos NV
Elizabeth Goodwin, Director 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.