Mechelen, Belgium; 15 April 2011 - Galapagos NV (Euronext: GLPG) announced today that it will discontinue its Phase II clinical trial for GLPG0259 in rheumatoid arthritis. This decision is based on the outcome of a planned interim analysis which did not support the continuation of GLPG0259's development for rheumatoid arthritis.
An Interim Review Committee of key opinion leaders in the field of rheumatology analyzed unblinded safety and efficacy data from the first 30 patients. Twenty patients received GLPG0259 and ten patients received placebo for a twelve week period. No serious adverse events or safety signals were reported. However, the committee recommended that study be discontinued due to limited efficacy potential of the compound in the Phase II trial. Galapagos intends to complete a full analysis of the data package prior to making a decision on the next steps for GLPG0259, including the position of the compound in other indications.
Galapagos will focus resources on its clinical programs in rheumatoid arthritis, cancer metastasis and cachexia, and on accelerating development of other candidate drugs in its broad portfolio. The Company has a large discovery pipeline in rheumatoid arthritis, including four novel mode-of-action molecules currently in late stage discovery under its rheumatoid arthritis research programs with Janssen Pharmaceutica NV.
"The innovative trial design used in this Phase II trial enabled quick determination regarding GLPG0259's potential efficacy in RA. We will now focus on accelerating the development of our other programs and continue to leverage our unique discovery platform to bring novel modes-of-action to the clinic," said Onno van de Stolpe, CEO of Galapagos. "Galapagos remains on-track to deliver the remainder of its operational objectives in 2011 as well as meet full year financial guidance of at least €150 million in revenues, profitability and positive cash flow in 2011."
About Galapagos' rheumatoid arthritis research programs with Janssen Pharmaceutica NV
In October 2007 Galapagos and Janssen Pharmaceutica NV signed two rheumatoid arthritis (RA) research agreements. Under the RA option agreement, Janssen has the exclusive option to license a program for €60 million upon delivery of a Phase IIa results package to Janssen by Galapagos. As part of this agreement, Galapagos is eligible to receive further potential milestones of €776 million and up to double-digit royalties on global sales for each program licensed by Janssen. Galapagos also has an alliance agreement with Janssen, which provides Janssen with option rights to acquire worldwide, commercial licenses to novel small-molecules from Galapagos' internal programs involving RA therapeutic targets. Besides GLPG0259, Galapagos currently has four programs in late stage discovery under its two research agreements with Janssen.
Galapagos will conduct its annual R&D Update during a conference call open to the public tomorrow, 15 April 2011, at 14.00 Central European Time (CET), which will also be webcast (view webcast). To participate in the conference call or the question and answer session following the presentation, please call +32 2290 1791 ten minutes prior to commencement. The archived webcast also will be available for replay shortly after the close of the call.
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 six programs in development and over 50 discovery programs. Through risk/reward-sharing alliances with GlaxoSmithKline, Eli Lilly, Janssen Pharmaceutica, Roche and Servier, Galapagos is eligible to receive up to €2.5 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
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
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