XBiotech Announces Agreement to Sell True Human Antibody Bermekimab Targeting IL-1a to Janssen
December 07 2019 - 3:05AM
XBiotech Inc. (NASDAQ: XBIT) announced today that it has entered
into a definitive agreement with Janssen Biotech, Inc., a Janssen
Pharmaceutical Company of Johnson & Johnson, to sell XBiotech’s
novel antibody (bermekimab) that neutralizes interleukin-1 alpha
(IL-1⍺). IL-1⍺ promotes disease-causing inflammation in a wide
range of medical conditions. Janssen will acquire all rights to
bermekimab under the terms of the agreement, and XBiotech will be
free to use its True Human Antibody discovery program to develop
new antibody therapeutics that target IL-1⍺ to treat
non-dermatological diseases. XBiotech plans to re-enter clinical
development expeditiously with a next generation anti-IL-1⍺
therapeutic.
Following the acquisition, XBiotech will use its
proprietary manufacturing technology to produce clinical supplies
of bermekimab for Janssen under a supply agreement. In addition,
XBiotech will contract with Janssen to provide clinical trial
operation services to complete two ongoing Phase II clinical
studies evaluating bermekimab in Hidradenitis Suppurativa and
Atopic Dermatitis.
Upon closing, Janssen will make a cash payment
of $750 million to XBiotech. In addition, XBiotech may receive up
to $600 million in potential milestone payments. XBiotech expects
to generate additional revenue from the manufacturing supply
agreement and clinical services agreement with Janssen over the
next two years.
XBiotech plans to use a portion of the proceeds
from this transaction to fund discovery and development of its next
generation True Human anti-IL-1⍺ antibody program. Additionally, a
portion of the revenue will be dedicated to advancing other
antibody therapeutics in XBiotech’s pipeline. The Company is also
planning to use part of the proceeds in a capital transaction, such
as a stock repurchase, subject to board review and approval.
John Simard, XBiotech’s President & CEO,
stated, “We are proud that Janssen has chosen bermekimab as an
agent it believes could have an important impact. We believe their
acquisition will enable recognition and increase awareness of the
full potential of this first-in-class therapeutic. This transaction
also provides us the opportunity to showcase our powerful True
Human antibody discovery platform, which we are now utilizing to
pursue next generation anti-Il-1⍺ antibody therapeutics to treat
multiple areas of unmet need outside of dermatology.”
The acquisition of bermekimab provides further
validation of the foundational science behind targeting IL-1a as a
means to block disease-causing inflammation. Clinical and
pre-clinical research suggests blocking IL-1a may be used to treat
a number of chronic and acute inflammatory conditions, including
skin disease, heart disease, heart attack, stroke, rheumatological
disease, gastrointestinal diseases, and cancer.
Simard further stated, “The cash infusion from
the bermekimab transaction will enable XBiotech to accelerate our
True Human antibody pipeline. The Company will also have sufficient
cash to support a significant capital transaction, which could
provide for a non-dilutive liquidity event for our valued
shareholders who have supported XBiotech’s pioneering work.”
The transaction is subject to customary closing
conditions, including clearance under the Hart-Scott-Rodino
Antitrust Improvements Act, and is expected to close shortly after
HSR approval.
About XBiotech XBiotech 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, and thereby have not been shown to
cause immunogenicity.) 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 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, including with respect to XBiotech’s strategic
ambitions, regarding the expected timing of closing of the
transaction with Janssen, filings and approvals relating to the
transaction, the amount and timing of potential future milestone
payments by Janssen, the mechanism of action and potential safety
and efficacy of bermekimab, the anticipated timing of clinical
studies with bermekimab, the progression and results of such
studies, statements regarding the regulatory pathway for bermekimab
and the timing of regulatory filings, and statements regarding any
capital allocation decisions, including as to potential share
repurchases. 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.
ContactAshley
Oteroaotero@xbiotech.com512-386-2930
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