XBiotech Announces Successful Completion of EMA GMP Inspection
October 12 2016 - 9:10AM
XBiotech Inc. (NASDAQ:XBIT), developer of next-generation True
Human™ therapeutic antibodies, today announced a successful GMP
(Good Manufacturing Practices) inspection by the European Medicines
Agency (EMA). The EMA’s Competent Authorities of France [The French
Agency for the Safety of Health Products], conducted the inspection
in connection with the Xilonix Marketing Authorization Application.
XBiotech’s production operations were deemed to be in general
compliance with the principles and guidelines of good manufacturing
practice as laid down in Commission Directive 2003/94/EC. The
findings allow the French Agency to recommend to the EMA XBiotech’s
current facility for the commercial manufacture of Xilonix.
XBiotech is pioneering a new manufacturing
process using disposable bioreactor technologies. These
manufacturing technologies reduce capital costs and operating
complexity while improving flexibility of biological manufacturing
compared to existing clean-in-place technologies. XBiotech CEO,
John Simard, commented, “The confirmation of GMP compliance is an
important step for our manufacturing platform and commercialization
capabilities.”
The GMP inspection was performed as part of the
evaluation of the Company’s Marketing Authorization Application for
Xilonix for the treatment of advanced colorectal cancer. The
Company expects EMA decision on the Marketing Application as early
as the end of 2016.
About True Human™ Therapeutic
AntibodiesUnlike previous generations of antibody
therapies, XBiotech’s True Human™ antibodies are derived without
modification from individuals who possess natural immunity to
certain diseases. With discovery and clinical programs across
multiple disease areas, XBiotech’s True Human antibodies have the
potential to harness the body’s natural immunity to fight disease
with increased safety, efficacy and tolerability.
About XBiotech XBiotech is
a fully integrated global biosciences company dedicated to
pioneering the discovery, development and commercialization of
therapeutic antibodies based on its True Human™ proprietary
technology. XBiotech currently is advancing a robust pipeline of
antibody therapies to redefine the standards of care in oncology,
inflammatory conditions and infectious diseases. Headquartered in
Austin, Texas, XBiotech also is leading the development of
innovative biotech manufacturing technologies designed to more
rapidly, cost-effectively and flexibly produce new therapies
urgently needed by patients worldwide. For more information, visit
www.xbiotech.com.
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Contact
Ashley Otero
aotero@xbiotech.com
512-386-2930
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