Tetris will be acquired by Arecor and
continue to commercialize Ogluo in the UK and EEA
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a
biopharmaceutical company developing and commercializing unique
therapies for patient populations in endocrinology and neurology,
today announced that Tetris Pharma—its commercialization partner
for Ogluo in the UK, EEA, and Switzerland—will be acquired by
Arecor Therapeutics (AIM: AREC), a UK-based, publicly traded,
globally focused biopharmaceutical company, contingent upon a
successful capital offering by Arecor Therapeutics. Under the terms
of the proposed acquisition, Arecor Therapeutics has agreed to
acquire Tetris Pharma and will continue to commercialize Ogluo in
the UK and EEA.
“We look forward to working with Arecor as our commercial
partner if the proposed acquisition is completed. Arecor is a
diversified and well capitalized company with a key focus on the
diabetes space. Having our ready-to-use glucagon, Ogluo,
commercialized in the UK and EEA by Arecor would be a very positive
step forward in our view,” said Paul R. Edick, Xeris’ Chairman and
CEO. “We are working expeditiously with Tetris and Arecor to affect
a smooth transition of commercial activities and will continue to
support the commercial efforts going forward.”
In July 2021, Xeris announced an exclusive agreement with Tetris
Pharma Limited (“Tetris”) for the commercialization of Ogluo® in
the European Economic Area, United Kingdom, and Switzerland (the
“Territory”) for the treatment of severe hypoglycemia in adults,
adolescents, and children aged 2 years and over with diabetes
mellitus. Under the terms of the applicable agreements, Xeris is
responsible for product supply and Tetris is responsible for the
commercialization of Ogluo in the Territory. Tetris Pharma has,
conditional upon completion of the Acquisition, entered into an
amendment to its exclusive 16-year minimum term license and supply
agreements with Xeris for the sale and distribution of Ogluo® in
the EEA, UK, and Switzerland. Pursuant to the license, a
mid-single-digit royalty on net sales is payable to Xeris over the
license period. In addition, further one-off commercial milestone
payments are payable to Xeris in the event that net revenues exceed
pre-defined targets in any single calendar year.
About Gvoke® (US) /Ogluo® (EU)
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
hypoglycaemia 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 authorisation on 11 February 2021. The
United Kingdom’s Medicines and Healthcare products Regulatory
Agency (MHRA) approved Ogluo® (glucagon) injection on April 29,
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 tumour. 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 hypoglycaemia. Gvoke is contraindicated in
patients with insulinoma. If a patient develops symptoms of
hypoglycaemia 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 hypoglycaemia only if sufficient
hepatic glycogen is present. Patients in states of starvation, with
adrenal insufficiency or chronic hypoglycaemia, 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 hypoglycaemia.
Adverse Reactions
Most common (≥5%) adverse reactions associated with Gvoke are
nausea, vomiting, injection site edema (raised 1 mm or greater),
and hypoglycaemia.
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 hypoglycaemia. 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 (hypoglycaemia), is also prevalent in this population due
to dysregulated glucagon secretion. Severe hypoglycaemia 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
hypoglycaemia. According to the American Diabetes Association,
glucagon should be prescribed for all individuals at increased risk
of clinically significant hypoglycaemia, defined as blood glucose
<54 mg/dL (3.0 mmol/L). Leveraging XeriSol™, one of Xeris’ two
proprietary formulation technology platforms, Xeris was able to
develop 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 hypoglycaemia and improve
glucose control.
About Severe Hypoglycaemia
Hypoglycemic events of any severity are a daily concern for
people with diabetes. Mild or moderate hypoglycaemia can occur
multiple times a month. Severe hypoglycaemia is characterized by
severe cognitive impairment, requiring external assistance for
recovery, and can be extremely frightening for patients and
caregivers. Severe hypoglycaemia 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
Xeris (Nasdaq: XERS) is a biopharmaceutical company developing
and commercializing unique therapies for patient populations in
endocrinology and neurology. 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
statements regarding the market and therapeutic products and
product candidates, the potential or likelihood of future payments
under the Tetris Agreement, the timing or likelihood of expansion
into additional markets, including, the EEA, future performance of
Tetris under the Tetris Agreement and anticipated results and
potential benefits of the commercialization partnership, , the
potential utility of its formulation platforms, the timing or
effects of the potential acquisition of Tetris 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. The factors described in the context of such
forward-looking statements in this communication 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. Although it is believed
that the expectations reflected in such forward-looking statements
are reasonable, no assurance can be given that such expectations
will prove to have been correct and persons reading this
communication are therefore cautioned not to place undue reliance
on these forward-looking statements which speak only as at the date
of this communication. 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
Securities and Exchange Commission, the contents of which are not
incorporated by reference into, nor do they form part of, this
communication. Any 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 true when made, may
ultimately prove to be incorrect. 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. All subsequent written and oral
forward-looking statements attributable to Xeris or any person
acting on behalf of any of them are expressly qualified in their
entirety by this paragraph.
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version on businesswire.com: https://www.businesswire.com/news/home/20220801005241/en/
Investor Contact Allison Wey Senior Vice President,
Investor Relations and Corporate Communications
awey@xerispharma.com 312-736-1237
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