Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty
pharmaceutical company leveraging its novel formulation technology
platforms to develop and commercialize ready-to-use injectable and
infusible drug formulations, today announced that the United
Kingdom’s Medicines and Healthcare Regulatory Agency (MHRA) has
approved Ogluo® (glucagon) injection for the treatment of severe
hypoglycaemia in adults, adolescents, and children aged 2 years and
over with diabetes mellitus.
In February, the European Commission (EC) approved Ogluo. As the
EC decision was received after the end of the Brexit transition
period, Xeris was required to complete a further administrative
step in order to obtain a license in Great Britain. No
re-examination of clinical data by MHRA was required. The marketing
authorization is valid in the United Kingdom, all 27 countries of
the European Union, Iceland, Norway, and Liechtenstein.
As previously stated, the Company is actively seeking a partner
to commercialize Ogluo in the U.K., EU, and other regions, with a
targeted fourth quarter 2021 launch in select EU countries.
ABOUT GVOKE/OGLUO
Gvoke® PFS and Gvoke HypoPen® (glucagon injection), the first
prescription, ready-to-use, pre-mixed, pre-measured glucagon
injection, were approved by the FDA in September 2019 for use in
the United States. Gvoke is indicated for the treatment of severe
hypoglycemia in pediatric and adult patients with diabetes ages 2
years and above. Ogluo received a positive opinion from the
European Medicines Agency’s (EMA) Committee for Medicinal Products
for Human Use (CHMP) in December 2020 and the European Commission
(EC) granted the marketing authorization on 11 February 2021. Ogluo
is indicated for the treatment of severe hypoglycaemia in adults,
adolescents, and children aged 2 years and over with diabetes
mellitus.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR GVOKE
Gvoke is indicated for the treatment of severe hypoglycaemia in
adult and paediatric patients with diabetes ages 2 years and
above.
IMPORTANT SAFETY INFORMATION
Contraindications
Gvoke is contraindicated in patients with pheochromocytoma,
insulinoma, and known hypersensitivity to glucagon or to any of the
excipients in Gvoke. Allergic reactions have been reported with
glucagon and include anaphylactic shock with breathing difficulties
and hypotension.
Warnings and Precautions
Gvoke is contraindicated in patients with pheochromocytoma
because glucagon may stimulate the release of catecholamines from
the tumor. If the patient develops a dramatic increase in blood
pressure and a previously undiagnosed pheochromocytoma is
suspected, 5 to 10 mg of phentolamine mesylate, administered
intravenously, has been shown to be effective in lowering blood
pressure.
In patients with insulinoma, administration of glucagon may
produce an initial increase in blood glucose; however, Gvoke
administration may directly or indirectly (through an initial rise
in blood glucose) stimulate exaggerated insulin release from an
insulinoma and cause hypoglycemia. Gvoke is contraindicated in
patients with insulinoma. If a patient develops symptoms of
hypoglycemia after a dose of Gvoke, give glucose orally or
intravenously.
Allergic reactions have been reported with glucagon. These
include generalized rash, and in some cases, anaphylactic shock
with breathing difficulties and hypotension. Gvoke is
contraindicated in patients with a prior hypersensitivity
reaction.
Gvoke is effective in treating hypoglycemia only if sufficient
hepatic glycogen is present. Patients in states of starvation, with
adrenal insufficiency or chronic hypoglycemia, may not have
adequate levels of hepatic glycogen for Gvoke administration to be
effective. Patients with these conditions should be treated with
glucose.
Necrolytic migratory erythema (NME), a skin rash commonly
associated with glucagonomas has been reported post-marketing
following continuous glucagon infusion and resolved with
discontinuation of the glucagon. Should NME occur, consider whether
the benefits of continuous glucagon infusion outweigh the risks.
Glucagon administered to patients with glucagonoma may cause
secondary hypoglycemia.
Adverse Reactions
Most common (≥5%) adverse reactions associated with Gvoke are
nausea, vomiting, injection site edema (raised 1 mm or greater),
and hypoglycemia.
Drug Interactions
Patients taking beta-blockers may have a transient increase in
pulse and blood pressure when given OGLUO. In patients taking
indomethacin, Gvoke may lose its ability to raise blood glucose or
may even produce hypoglycemia. Gvoke may increase the anticoagulant
effect of warfarin.
Please see full Prescribing Information for Gvoke on
www.xerispharma.com. Manufactured for Xeris Pharmaceuticals, Inc.
by Pyramid Laboratories Inc., Costa Mesa, CA 92626.
About Glucagon
Glucagon is a metabolic hormone secreted by the pancreas that
raises blood glucose levels by causing the liver to rapidly convert
glycogen (the stored form of glucose) into glucose, which is then
released into the bloodstream. Glucagon and insulin are two
critical hormones in a glycemic control system that keep blood
glucose at the right level in healthy individuals. In people with
diabetes who are dependent on insulin, this control system is
disrupted, and insulin must be injected to avoid high levels of
blood glucose (hyperglycemia). The opposite effect, or low blood
glucose (hypoglycemia), is also prevalent in this population due to
dysregulated glucagon secretion. Severe hypoglycemia is a serious
condition and can lead to seizures, coma, potential brain injury
and, if untreated, death.
Glucagon is the standard of care for treating severe
hypoglycemia. According to the American Diabetes Association,
glucagon should be prescribed for all individuals at increased risk
of clinically significant hypoglycemia, defined as blood glucose
<54 mg/dL (3.0 mmol/L). Leveraging XeriSol™, one of Xeris’ two
proprietary formulation technology platforms, Xeris has the
potential to provide the first ready-to-use, room-temperature
stable liquid glucagon for use by people with diabetes and other
conditions to prevent or manage various forms of hypoglycemia and
improve glucose control.
About Severe Hypoglycemia
Hypoglycemic events of any severity are a daily concern for
people with diabetes. Mild or moderate hypoglycemia can occur
multiple times a month. Severe hypoglycemia is characterized by
severe cognitive impairment, requiring external assistance for
recovery, and can be extremely frightening for patients and
caregivers. Severe hypoglycemia can result in cardiovascular
disease, seizure, coma, and, if left untreated, death. These severe
hypoglycemic events can occur multiple times a year. Such events
require emergency assistance from another person or caregiver such
as a family member, friend, or co-worker.
About Xeris Pharmaceuticals, Inc.
Xeris (Nasdaq: XERS) is a specialty pharmaceutical company
delivering innovative solutions to simplify the experience of
administering important therapies that people rely on every day
around the world. With a novel technology platform that enables
ready-to-use, room-temperature stable formulations of injectable
and infusible therapies, the company is advancing a portfolio of
solutions in various therapeutic categories, including its first
U.S. commercial product, Gvoke®. Its proprietary XeriSol™ and
XeriJect™ formulation technologies have the potential to offer
distinct advantages over conventional product formulations,
including eliminating the need for reconstitution, enabling
long-term, room-temperature stability, significantly reducing
injection volume, and eliminating the requirement for intravenous
(IV) infusion. With Xeris’ technology, new product formulations are
designed to be easier to use by patients, caregivers, and health
practitioners and help reduce costs for payers and the healthcare
system.
Xeris 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 Pharmaceuticals, Inc., including
statements regarding the market and therapeutic potential of its
products and product candidates, expectations regarding clinical
data or results from planned 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 timing or likelihood of identifying
potential development and commercialization partnerships, the
potential utility of its formulation platforms 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.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including, without limitation, the impact of COVID-19 on
its business operations, its reliance on third-party suppliers for
Gvoke® and Ogluo®, the regulatory approval of its product
candidates, its ability to market and sell its products, if
approved, and other factors discussed in the "Risk Factors" section
of the most recently filed Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission, as well as discussions of
potential risks, uncertainties, and other important factors in
Xeris’ subsequent filings with the Securities and Exchange
Commission. Any forward-looking statements contained in this press
release speak only as of the date hereof, and Xeris expressly
disclaims any obligation to update any forward-looking statements,
whether as a result of new information, future events or
otherwise.
The Company intends to use the investor relations portion of its
website as a means of disclosing material non-public information
and for complying with disclosure obligations under Regulation
FD.
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version on businesswire.com: https://www.businesswire.com/news/home/20210429006009/en/
Xeris Investor Contact Allison Wey Senior Vice President,
Investor Relations and Corporate Communications
awey@xerispharma.com 312-736-1237
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