Xeris Biopharma Announces the Availability of Ogluo® in the UK Through Its Commercialization Partner, Tetris Pharma
CHICAGO–(BUSINESS WIRE)–Dec. 16, 2021– 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 firstname.lastname@example.org.
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.
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.
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.
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Source: Xeris Biopharma