MECHELEN, BELGIUM--(Marketwire - December 03, 2012) - Galapagos NV (EURONEXT BRUSSELS: GLPG)
announced
today that it has opened its Investigational New Drug application for
GLPG0634
with the US Food and Drug Administration.
Galapagos intends to conduct a Phase 1 drug interaction study in the
United
States, which is expected to be completed in the first quarter of
2013.
Acceptance of the IND was based on a review by the FDA of the GLPG0634
data
package, including chemical/pharmaceutical data, preclinical data up
to the
formal 13-week toxicology studies and currently completed clinical studies.
"This is an important step in our clinical development plan for GLPG0634,"
said
Piet Wigerinck, CSO of Galapagos. "The FDA has reviewed all
the GLPG0634 pre-clinical and clinical data to date and found these
supportive of the conduct of
our first clinical trial within the United States. We will follow up
with
studies in rheumatoid arthritis patients next year, and intend to
include US
study centers in our Phase 2b program."
About Investigational New Drug (IND) Application
United States Federal law requires a pharmaceutical company to
obtain an
exemption to ship an experimental drug across state lines, usually to
clinical
investigators, before a marketing application for the drug has been
approved.
The IND is the means by which the sponsor technically obtains this
exemption.
The FDA reviews the IND for safety to assure that research subjects will
not be
subjected to unreasonable risk. The IND application contains
information in
three broad areas: animal pharmacology and toxicology studies,
clinical
protocols and investigator information, and manufacturing information.
About Galapagos
Galapagos (EURONEXT BRUSSELS: GLPG) (PINKSHEETS: GLPYY) is a mid-size
clinical stage biotechnology company specialized in the discovery and
development of small molecule and antibody therapies with
novel modes-of-action. The Company is progressing its JAK1 inhibitor
GLPG0634, as well as one of the largest pipelines
in biotech, with four programs in development and over 30 discovery
programs.
The Galapagos Group has over 800 employees and operates facilities
in six
countries, with global headquarters in Mechelen, Belgium. More
info at:
www.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,"
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different
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achievements expressed or implied by such forward-looking statements.
Given
these uncertainties, the reader is advised not to place any undue
reliance on
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only as
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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.
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Source: Galapagos NV via Thomson Reuters ONE
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