Galapagos discontinues Phase II trial for GLPG0259, focuses resources on other rheumatoid arthritis programs
(Thomson Reuters ONE) -
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.
Conference call and webcast presentation
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.
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 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
CONTACT
Galapagos NV
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
ir(at)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
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Source: Galapagos NV via Thomson Reuters ONE
[HUG#1506751]
Unternehmensinformation / Kurzprofil:
Datum: 15.04.2011 - 07:30 Uhr
Sprache: Deutsch
News-ID 53572
Anzahl Zeichen: 6816
contact information:
Town:
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Kategorie:
Business News
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