XBiotech Inks Clinical Manufacturing Deal
2022年2月2日 - 11:00PM
XBiotech Inc. (NASDAQ: XBIT) announced today that it executed
Manufacturing Agreement with Janssen Research & Development,
LLC to manufacture clinical product, including Bermekimab, a True
Human monoclonal antibody sold to Janssen by XBiotech in December
2019.
XBiotech discovers and develops therapeutics
based on antibodies it identifies from donors with natural human
immunity against disease. XBiotech has also developed a unique
manufacturing technology and has a state-of-the-art production
facility at its headquarters in Austin, Texas.
The Company’s manufacturing technology and
production facilities support commercialization of the Company’s
internally discovered candidate drugs. Contract drug manufacturing
services to third parties have not been an integral part of the
Company’s business strategy. However, with the sale to Janssen of
bermekimab in 2019, XBiotech committed to provide manufacturing
services during a transitional period to Janssen and has been
manufacturing bermekimab under contract since the sale. The new
agreement will extend XBiotech’s manufacturing support until
December, 2023.
John Simard, XBiotech’s Chairman and CEO,
stated, “We are pleased to be able to continue to support Janssen
in its development of bermekimab. While contract manufacturing is
not a core business, manufacturing bermekimab fits well into our
system and revenue generated extends our runway for the development
of our up and coming therapeutics.”
About XBiotechXBiotech is
a fully integrated, global biopharmaceutical company dedicated to
pioneering the discovery, development and commercialization of
therapeutic antibodies. XBiotech currently is advancing a pipeline
of therapies by harnessing naturally occurring antibodies from
patients with immunity to certain diseases. Utilizing natural human
immunity as a source of new medicines offers the potential to
redefine the standards of care for a wide range of diseases. The
discovery and manufacturing techniques which enable this were
designed by and are exclusive to XBiotech. Headquartered in Austin,
Texas, XBiotech also leads the development of innovative,
proprietary manufacturing technology to reduce the cost and
complexity of biological drug production. For more information,
visit www.xbiotech.com.
About True Human™ Therapeutic
AntibodiesXBiotech’s True Human™ antibodies are the only
available antibodies derived without modification from humans who
possess natural immunity to certain diseases. (Unlike all
commercially available antibodies, which are called “Humanized” or
“Fully Human,” XBiotech’s True Human™ antibodies are directly
sourced from the natural human immune response for specific
diseases without modification). XBiotech’s True Human antibodies
have the potential to harness the body’s natural immunity to fight
disease with unprecedented safety, efficacy, and tolerability.
Cautionary Note on Forward-Looking
StatementsThis 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 XBiotechWenyi
Weiwwei@xbiotech.comTel. 512-386-2934
XBiotech (NASDAQ:XBIT)
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から 1 2024 まで 1 2025