XBiotech Announces Successful Completion of EMA GMP Inspection

ID: 1463297
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(Thomson Reuters ONE) -




Manufacturing Operations Found to be in Compliance with GMP Guidelines

AUSTIN, Texas, Oct. 12, 2016 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT),
developer of next-generation True Human(TM) 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(TM) Therapeutic Antibodies
Unlike previous generations of antibody therapies, XBiotech''s True Human(TM)
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(TM) 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.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements, including declarations
regarding management''s beliefs and expectations that involve substantial risks
and uncertainties. In some cases, you can identify forward-looking statements by
terminology such as "may," "will," "should," "would," "could," "expects,"
"plans," "contemplate," "anticipates," "believes," "estimates," "predicts,"
"projects," "intend" or "continue" or the negative of such terms or other
comparable terminology, although not all forward-looking statements contain
these identifying words. Forward-looking statements are subject to inherent
risks and uncertainties in predicting future results and conditions that could
cause the actual results to differ materially from those projected in these
forward-looking statements. These risks and uncertainties are subject to the
disclosures set forth in the "Risk Factors" section of certain of our SEC
filings. Forward-looking statements are not guarantees of future performance,
and our actual results of operations, financial condition and liquidity, and the
development of the industry in which we operate, may differ materially from the
forward-looking statements contained in this press release. Any forward-looking
statements that we make in this press release speak only as of the date of this
press release. We assume no obligation to update our forward-looking statements
whether as a result of new information, future events or otherwise, after the
date of this press release.

Contact
Ashley Otero
aotero(at)xbiotech.com
512-386-2930






This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: XBiotech, Inc via GlobeNewswire






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Date: 10/12/2016 - 09:12
Language: English
News-ID 1463297
Character count: 3417
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Firma: XBiotech, Inc
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