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 it has entered
into an exclusive distribution agreement with Megapharm Ltd.
(“Megapharm”), a leading Israel-based pharmaceutical company, for
the commercialization in Israel and the Palestinian Authority of
Xeris’ Gvoke® (glucagon injection) for the treatment of severe
hypoglycemia in adults and children with diabetes ages 2 years and
above. Gvoke® is the world’s first and only ready-to-use liquid
glucagon.
Under the terms of the agreement, Megapharm will be responsible
for registration and marketing of Gvoke® in Israel and the
Palestinian Authority, as well as named patient services supply,
and Xeris will be responsible for manufacturing, product supply,
quality assurance and control, regulatory support, and maintenance
of IP. Gvoke® is expected to be available in Israel in 2022. Gvoke®
will also be available in Israel prior to registration on a named
patient basis starting in early 2021.
“This agreement represents a major milestone in our business
development strategy to expand our international distribution for
Gvoke® so that more insulin taking patients with diabetes can have
access to it,” said Paul R. Edick, Chief Executive Officer and
Chairman of Xeris. “Megapharm is a well-respected marketing company
with a track record of successfully commercializing innovative
products in Israel, and we look forward to working with them.”
Miron Drucker, CEO of Megapharm, said, “We are proud to
establish this partnership with Xeris to bring Gvoke® to the
diabetes communities in Israel and the Palestinian Authority.”
About GVOKE®
Xeris received U.S. regulatory approval in 2019 for GVOKE®
(glucagon) injection, its ready-to-use, room-temperature stable
liquid glucagon for the treatment of severe hypoglycemia in
pediatric and adult patients with diabetes ages 2 years and above.
The Company continues to evaluate additional applications to
address needs in severe hypoglycemia and related conditions.
Important Safety Information and a link to full prescribing
information may be found at https://www.gvokeglucagon.com.
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
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.
About Megapharm Ltd.
Megapharm Ltd. is a leading Israeli private pharma marketing
company, founded in 1989, exclusively representing a number of
major American, European and Japanese pharmaceutical companies.
Megapharm provides its partners with a full set of commercial
capabilities, including registration, market access and sales and
marketing. Megapharm has demonstrated dynamic sales growth by
developing a strong company presence and expertise in selected
therapeutic areas (i.e. Oncology, Hematology, CNS, Orphan and
metabolic drugs) and a proven track record of obtaining national
reimbursement and inclusion of its products in Health Funds in
Israel. Additional information can be found at:
www.megapharm.co.il.
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
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 a potential
development and commercialization partnership, 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®, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201222005114/en/
Xeris Investor Contact Allison Wey Senior Vice President,
Investor Relations and Corporate Communications
awey@xerispharma.com 312-736-1237 Megapharm Business
Development Guy Schmidt Head of Business Development
guy.schmidt@megapharm.co.il +972 9 7604596
Xeris Biopharma (NASDAQ:XERS)
Historical Stock Chart
From Apr 2024 to May 2024
Xeris Biopharma (NASDAQ:XERS)
Historical Stock Chart
From May 2023 to May 2024