MECHELEN, BELGIUM--(Marketwire - December 03, 2012) - Galapagos NV (EURONEXT BRUSSELS: GLPG)
today that it has opened its Investigational New Drug application for
with the US Food and Drug Administration.
Galapagos intends to conduct a Phase 1 drug interaction study in the
States, which is expected to be completed in the first quarter of
Acceptance of the IND was based on a review by the FDA of the GLPG0634
package, including chemical/pharmaceutical data, preclinical data up
formal 13-week toxicology studies and currently completed clinical studies.
"This is an important step in our clinical development plan for GLPG0634,"
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
studies in rheumatoid arthritis patients next year, and intend to
study centers in our Phase 2b program."
About Investigational New Drug (IND) Application
United States Federal law requires a pharmaceutical company to
exemption to ship an experimental drug across state lines, usually to
investigators, before a marketing application for the drug has been
The IND is the means by which the sponsor technically obtains this
The FDA reviews the IND for safety to assure that research subjects will
subjected to unreasonable risk. The IND application contains
three broad areas: animal pharmacology and toxicology studies,
protocols and investigator information, and manufacturing information.
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
The Galapagos Group has over 800 employees and operates facilities
countries, with global headquarters in Mechelen, Belgium. More
This release may contain forward-looking statements, including,
limitation, statements containing the words "believes,"
"expects," "intends," "plans," "seeks," "estimates," "may," "will,"
"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,
or achievements of Galapagos, or industry results, to be materially
from any historic or future results, financial conditions,
achievements expressed or implied by such forward-looking statements.
these uncertainties, the reader is advised not to place any undue
such forward-looking statements. These forward-looking statements speak
of the date of publication of this document. Galapagos expressly
obligation to update any such forward-looking statements in this
reflect any change in its expectations with regard thereto or any
events, conditions or circumstances on which any such statement is based,
required by law or regulation.
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Source: Galapagos NV via Thomson Reuters ONE