Xeris Pharmaceuticals Signs Exclusive Agreement With Clinigen to Supply & Distribute Gvoke™ Outside the U.S on a Named Pati...
May 14 2020 - 3:00AM
Business Wire
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 an exclusive agreement
with Clinigen Group plc (AIM: CLIN, ‘Clinigen’) to manage the
supply and distribution of Gvoke™ outside of the United States
where Gvoke is not currently licensed.
“In an effort to make ready-to-use Gvoke as accessible as
possible to people with diabetes and in response to requests while
our MAA is under review with the EMA, we have partnered with
Clinigen, a distributor of unlicensed medicines. With Clinigen’s
global infrastructure and expertise in the distribution of
important unlicensed medicines, we can enable people with diabetes
around the world to access Gvoke,” said Paul R. Edick, Chairman and
CEO of Xeris. “It is especially important during this global health
crisis that people with diabetes, who the CDC and others have
identified as an at-risk population, have access to medicines like
Gvoke, which can enable them to self-treat and avoid going to a
busy hospital or medical center to receive care.”
All Gvoke product requests must be submitted by the treating
physician on behalf of the patient. Healthcare professionals can
obtain details about the Gvoke Managed Access Program by calling
the Clinigen customer service team at +44 (0) 1283 494 340 or
emailing medicinesaccess@clinigengroup.com. Patients seeking
medical information should contact their physician. Learn more at
https://www.gvokeglucagon.com/hcp.
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,
and 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 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 Clinigen Group plc
Clinigen Group plc is a global pharmaceutical and services
company with a unique combination of businesses focused on
providing ethical access to medicines. Its mission is to deliver
the right medicine to the right patient at the right time through
three areas of global medicine supply: clinical trial, unlicensed
and licensed medicines. The Group has sites in North America,
Europe, Africa and Asia Pacific. Clinigen has over 1,100 employees
across five continents in 14 countries, with supply and
distribution hubs and operational centers of excellence in key
long-term growth regions. The Group works with 22 of the top 25
pharmaceutical companies, interacting with over 15,000 registered
users across over 100 countries, and shipping approximately 6.4
million units in the year. For more information on Clinigen, please
visit www.clinigengroup.com.
Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Xeris Pharmaceuticals, Inc., including
statements regarding the timing of the commercial launch of Gvoke
HypoPen™, the availability of supply of Gvoke PFS for the balance
of 2020, the availability of Gvoke PFS for home delivery, the
acceptance of Gvoke™ in the marketplace, and other statements
containing the words “plans”, “expects”, “anticipates”, "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 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 Annual Report on Form 10-K 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/20200514005105/en/
Xeris Investor Contact Allison Wey Senior Vice President,
Investor Relations and Corporate Communications
awey@xerispharma.com 312-736-1237
Xeris Biopharma (NASDAQ:XERS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Xeris Biopharma (NASDAQ:XERS)
Historical Stock Chart
From Sep 2023 to Sep 2024