Galapagos opens IND for GLPG0634 in the US
(Thomson Reuters ONE) -
Mechelen, Belgium; 3 December 2012 - Galapagos NV (Euronext: 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: GLPG; OTC: 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
CONTACT
Galapagos NV
Dr Piet Wigerink, Chief Scientific Officer
Tel. +32 477 627103
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
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.
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Source: Galapagos NV via Thomson Reuters ONE
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