Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented
biopharmaceutical company committed to improving patient lives by
developing and commercializing innovative products across a range
of therapies, today announced that it has entered into an exclusive
worldwide license agreement for Amgen to develop, manufacture, and
commercialize a subcutaneous formulation of teprotumumab using
Xeris’ XeriJect® technology in Thyroid Eye Disease (TED) - a
serious, progressive and potentially vision-threatening rare
autoimmune disease. Teprotumumab-trbw is known as TEPEZZA® in the
United States.
“We are very excited that our partner is moving forward with
licensing the XeriJect technology to further the development of the
XeriJect subcutaneous teprotumumab to potentially enhance the
patient experience and delivery of the treatment for Thyroid Eye
Disease. This agreement to license XeriJect further validates the
potential value of our technology to enable large molecule
subcutaneous injections that provide a more patient friendly
regimen that is effective, safe, and more convenient, with
potential for improved adherence,” said Paul R. Edick, Chairman and
CEO of Xeris. “We will move quickly to support our partner in this
important development program.”
Under the terms of the License Agreement, Xeris has the
potential to receive $75 million in development and regulatory
milestones, plus sales-based milestones, as well as escalating
single-digit royalties based on future sales of TEPEZZA using the
XeriJect technology.
About XeriJect®
XeriJect formulations are innovative, ready-to-use, viscoelastic
pharmaceutical suspensions that have the potential to improve drug
delivery, lower treatment burden and improve patients' lives across
a broad range of therapeutic categories. XeriJect suspensions
maximize drug loadings at >400mg/mL, enable small volume
subcutaneous injections and do not settle on storage. The
suspensions use FDA-approved excipients and leverage known
manufacturing processes. XeriJect formulation technology is well
suited for drugs and biologics including large molecules such as
proteins, monoclonal antibodies, and vaccines. The technology is
protected by an extensive patent estate, trade secrets and
know-how, and it is available for licensing.
About Xeris
Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical
company committed to improving patients’ lives by developing and
commercializing innovative products across a range of therapies.
Xeris has three commercially available products; Gvoke®, a
ready-to-use liquid glucagon for the treatment of severe
hypoglycemia, Keveyis®, for a proven therapy for primary periodic
paralysis, and Recorlev® for the treatment of endogenous Cushing’s
syndrome. Xeris also has a robust pipeline of development programs
to extend the current marketed products into important new
indications and uses and bring new products forward using its
proprietary formulation technology platforms, XeriSol™ and
XeriJect®, supporting long-term product development and commercial
success.
Xeris Biopharma Holdings is headquartered in Chicago, IL. For
more information, visit www.xerispharma.com, or follow us on X,
LinkedIn, or Instagram.
Forward-Looking Statements
Any statements in this press release other than statements of
historical fact are forward-looking statements. Forward-looking
statements include, but are not limited to, statements about future
expectations, plans and prospects for Xeris Biopharma Holdings,
Inc., including the development and potential of XeriJect®
subcutaneous TEPEZZA®, the expectations regarding future product
development efforts between Xeris and Amgen, Xeris’ potential
entitlements to milestone and royalty payments from Amgen, the
potential utility of its formulation platforms such as XeriJect,
the market and therapeutic potential of its products and product
candidates, and other statements containing the words “will,”
“would,” “continue,” “expect,” “should,” “anticipate” and similar
expressions, constitute forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995.
These forward-looking statements are based on numerous assumptions
and assessments made in light of Xeris’ experience and perception
of historical trends, current conditions, business strategies,
operating environment, future developments, geopolitical factors
and other factors it believes appropriate. By their nature,
forward-looking statements involve known and unknown risks and
uncertainties because they relate to events and depend on
circumstances that will occur in the future. The various factors
that could cause Xeris’ actual results, performance or
achievements, industry results and developments to differ
materially from those expressed in or implied by such
forward-looking statements, include, but are not limited to, its
financial position and need for financing, including to fund its
product development programs or commercialization efforts, whether
its products will achieve and maintain market acceptance in a
competitive business environment, its reliance on third-party
suppliers, including single-source suppliers, its reliance on third
parties to conduct clinical trials, the ability of its product
candidates to compete successfully with existing and new drugs, and
its and collaborators’ ability to protect its intellectual property
and proprietary technology. No assurance can be given that such
expectations will be realized and persons reading this
communication are, therefore, cautioned not to place undue reliance
on these forward-looking statements. Additional risks and
information about potential impacts of financial, operational,
economic, competitive, regulatory, governmental, technological, and
other factors that may affect Xeris can be found in Xeris’ filings,
including its most recently filed Quarterly Report on Form 10-Q
filed with the Securities and Exchange Commission, the contents of
which are not incorporated by reference into, nor do they form part
of, this communication. Forward-looking statements in this
communication are based on information available to us, as of the
date of this communication and, while we believe our assumptions
are reasonable, actual results may differ materially. Subject to
any obligations under applicable law, we do not undertake any
obligation to update any forward-looking statement whether as a
result of new information, future developments or otherwise, or to
conform any forward-looking statement to actual results, future
events, or to changes in expectations.
About TEPEZZA
INDICATION
TEPEZZA is indicated for the treatment of Thyroid Eye Disease
regardless of Thyroid Eye Disease activity or duration.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Infusion Reactions: TEPEZZA may cause infusion reactions.
Infusion reactions have been reported in approximately 4% of
patients treated with TEPEZZA. Reported infusion reactions have
usually been mild or moderate in severity. Signs and symptoms may
include transient increases in blood pressure, feeling hot,
tachycardia, dyspnea, headache, and muscular pain. Infusion
reactions may occur during an infusion or within 1.5 hours after an
infusion. In patients who experience an infusion reaction,
consideration should be given to premedicating with an
antihistamine, antipyretic, or corticosteroid and/or administering
all subsequent infusions at a slower infusion rate.
Preexisting Inflammatory Bowel Disease: TEPEZZA may cause
an exacerbation of preexisting inflammatory bowel disease (IBD).
Monitor patients with IBD for flare of disease. If IBD exacerbation
is suspected, consider discontinuation of TEPEZZA.
Hyperglycemia: Increased blood glucose or hyperglycemia
may occur in patients treated with TEPEZZA. In clinical trials, 10%
of patients (two-thirds of whom had preexisting diabetes or
impaired glucose tolerance) experienced hyperglycemia.
Hyperglycemic events should be controlled with medications for
glycemic control, if necessary. Assess patients for elevated blood
glucose and symptoms of hyperglycemia prior to infusion and
continue to monitor while on treatment with TEPEZZA. Ensure
patients with hyperglycemia or preexisting diabetes are under
appropriate glycemic control before and while receiving
TEPEZZA.
Hearing Impairment Including Hearing Loss: TEPEZZA may
cause severe hearing impairment including hearing loss, which in
some cases may be permanent. Assess patients’ hearing before,
during, and after treatment with TEPEZZA and consider the
benefit-risk of treatment with patients.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥5% and greater
than placebo) are muscle spasm, nausea, alopecia, diarrhea,
fatigue, hyperglycemia, hearing impairment, dysgeusia, headache,
dry skin, weight decreased, nail disorders, and menstrual
disorders.
Please see Full Prescribing Information or
visit TEPEZZAhcp.com for more information.
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version on businesswire.com: https://www.businesswire.com/news/home/20240109335095/en/
Allison Wey Senior Vice President, Investor Relations and
Corporate Communications awey@xerispharma.com
Xeris Biopharma (NASDAQ:XERS)
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