Xeris Biopharma Announces the Availability of Ogluo® in the UK Through Its Commercialization Partner, Tetris Pharma
December 16 2021 - 7:00AM
Business Wire
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a
biopharmaceutical company developing and commercializing unique
therapies for patient populations in endocrinology, neurology, and
gastroenterology, today announced that its commercialization
partner, Tetris Pharma (Tetris), has launched Ogluo® (glucagon
injection) in the United Kingdom and it is now available by
prescription for the treatment of severe hypoglycemia in adults,
adolescents, and children aged 2 years and over with diabetes
mellitus.
In July, Xeris announced a licensing agreement with Tetris for
the commercialization of Ogluo (European brand name of Gvoke®) in
the European Union area, the UK, and Switzerland (the Territory).
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, starting with the UK.
Tetris aims for Ogluo to be launched in several countries across
Europe during 2022.
“Just as Gvoke has the potential to change lives for people in
the US with diabetes, we are delighted that Ogluo is now accessible
to people in the UK and will be available in other European
countries in 2022,” said Paul R. Edick, Chairman and CEO of Xeris.
“Having a product that is ready-to-use will be a real benefit to
both people with diabetes and their caregivers in the case of a
severe hypoglycemic event.”
Xeris estimates there are approximately five million people with
diabetes and at risk of severe hypoglycemia in the UK, with only an
estimated 10-20% having a prescription for glucagon.
Healthcare professionals can obtain details about Ogluo® by
emailing medinfo@tetrispharma.com.
ABOUT GVOKE® (US) / OGLUO® (EU)
Gvoke® (glucagon injection), the first prescription,
ready-to-use, pre-mixed, pre-measured glucagon injection, was
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® (glucagon injection) 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. The
United Kingdom’s Medicines and Healthcare products Regulatory
Agency (MHRA) approved Ogluo on April 29, 2021. Ogluo is indicated
for the treatment of severe hypoglycemia in adults, adolescents,
and children aged 2 years and over with diabetes mellitus.
About Tetris
Tetris Pharma is a UK-based ‘niche specialty’ pharmaceutical
company with extensive experience of launching products, not only
in the UK, but across Europe. Our vision is to build a pan-European
pharmaceutical company that specializes in marketing a range of
prescription products in areas of unmet clinical need. Tetris has a
team of highly experienced and complementary individuals, with
international expertise across a range of therapeutic areas and
in-depth understanding of the complexities of the EU environment
allowing them to maximise sales potential.
About Xeris Biopharma
Xeris (Nasdaq: XERS), is a biopharmaceutical company developing
and commercializing unique therapies for patient populations in
endocrinology, neurology, and gastroenterology. Xeris has two
commercially available products, Gvoke®, a ready-to-use liquid
glucagon for the treatment of severe hypoglycemia, and Keveyis®,
the first and only FDA-approved therapy for primary periodic
paralysis. In addition to Recorlev® for the treatment of 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 potential of Xeris’
products and product candidates, the timing or likelihood of
expansion into additional markets, including, the United Kingdom in
the fourth quarter of 2021 and additional countries within the
Territory by mid-2022, future performance of Tetris under the
agreements and anticipated results and potential benefits of the
commercialization partnership, the potential utility of Xeris’
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 Xeris’ business operations,
Xeris’ reliance on third-party suppliers for Gvoke®/Ogluo®, the
regulatory approval of Xeris’ product candidates, Xeris’ 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 nonpublic information
and for complying with disclosure obligations under Regulation
FD.
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Xeris Investor Contact Allison Wey Senior Vice President,
Investor Relations and Corporate Communications
awey@xerispharma.com 312-736-1237
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