Xeris to develop an ultra-concentrated,
ready-to-use, subcutaneous injection of teprotumumab
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 a research
collaboration and option agreement with Horizon Therapeutics plc
(Nasdaq: HZNP). Under the terms of the agreement, Xeris will use
its proprietary formulation technology platform, XeriJect™, to
develop an ultra-concentrated, ready-to-use, subcutaneous injection
of teprotumumab and Horizon will have an option to license the
Xeris technology. Teprotumumab is the first and only medicine
approved by the U.S. Food and Drug Administration (FDA) for the
treatment of Thyroid Eye Disease (TED) – a serious, progressive and
potentially vision-threatening rare autoimmune disease.
Teprotumumab-trbw is known as TEPEZZA® in the United States.
Xeris will receive an upfront payment, and may be entitled to
receive development milestones, regulatory milestones, and
sales-based milestones, as well as royalties based on future sales
if the commercial license option is exercised. Specific financial
terms of the agreement were not disclosed.
“We are excited to announce our collaboration with Horizon for
the development of a subcutaneous formulation of teprotumumab using
our XeriJect technology to potentially enhance the patient
experience and delivery of the treatment for Thyroid Eye Disease,”
said Paul R. Edick, Chairman and CEO of Xeris. “This partnership
demonstrates 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.”
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®, the first and only FDA-approved 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
Twitter, LinkedIn, or Instagram.
Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Xeris Biopharma Holdings, Inc., including
the development of a subcutaneous formulation of teprotumumab, the
market and therapeutic potential of Xeris’ products and product
candidates, expectations regarding clinical data or results from
planned clinical trials, the timing of clinical trials, the timing
or likelihood of regulatory approval and commercialization of its
product candidates, the timing or likelihood of expansion into
additional markets, the potential utility of its proprietary
formulation technology platforms, the potential to receive
milestone payments if Horizon exercises its option and other
statements containing the words “will,” “would,” “continue,” 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, 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. Various factors 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, including the impact of
COVID-19 on our business operations and clinical activities, our
ability to fund our product development programs or
commercialization efforts, and whether our products will achieve
and maintain market acceptance. No assurance can be given that our
expectations will be realized and persons reading this
communication are, therefore, cautioned not to place undue reliance
on these forward-looking statements. Additional information about
economic, competitive, governmental, technological, and other
factors that may affect Xeris is set forth in the "Risk Factors"
section of the most recently filed Quarterly Report on Form 10-Q
filed with the U.S. Securities and Exchange Commission, the
contents of which are not incorporated by reference into, nor do
they form a part of, this communication. Forward-looking statements
in this communication are based upon information available to
Xeris, as of the date of this communication and, while believed to
be reasonable, actual results may differ materially. Subject to any
obligations under applicable law, Xeris does 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.
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 managed with medications for
glycemic control, if necessary. Monitor patients for elevated blood
glucose and symptoms of hyperglycemia while on treatment with
TEPEZZA. Patients with preexisting diabetes should be under
appropriate glycemic control before receiving TEPEZZA.
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, 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/20221122005608/en/
Allison Wey Senior Vice President, Investor Relations and
Corporate Communications awey@xerispharma.com 312-736-1237
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