BURTON-ON-TRENT, England, May 14, 2020 / B3C newswire / -- Clinigen Group plc (AIM: CLIN, ‘Clinigen’), the global pharmaceutical and services company, has signed an exclusive agreement with Xeris Pharmaceuticals, Inc. (NASDAQ: XERS, ‘Xeris’) to manage the supply and distribution of Gvoke™ (glucagon) injection, a treatment for diabetes, outside the US.
Under the terms of the supply and distribution agreement with Xeris, Clinigen will provide physicians and pharmacists with access to Gvoke™ on an unlicensed, on-demand basis for patients around the world, excluding the US.
Gvoke™ (glucagon) injection, is a ready-to-use, room-temperature stable liquid glucagon for the treatment of severe hypoglycaemia in paediatric and adult patients with diabetes ages two years and above. Gvoke™ received US regulatory approval in 2019 and is the first glucagon product approved that can be administered via a prefilled syringe (Gvoke™ PFS) or auto-injector (Gvoke HypoPen™), reducing the steps to prepare and administer glucagon in patients with low blood sugar levels.
Gvoke™ PFS is available in two doses: a 0.5 mg/0.1 mL dose for paediatric patients and a 1 mg/0.2 mL dose for adolescent and adult patients. Xeris anticipates Gvoke HypoPen™ to be available in July 2020 and will also be in two doses: a 0.5 mg/0.1 mL dose for paediatric patients and a 1 mg/0.2 mL dose for adolescent and adult patients.
James Winterman, Executive Vice President of Unlicensed Medicines, Clinigen, said: “We look forward to working with Xeris to make Gvoke™ available on an unlicensed basis outside the US. Diabetes affects millions of people around the world, and Gvoke™ could be a critical medicine for treating hypoglycaemia. This agreement demonstrates our commitment in partnering with pharmaceutical companies to provide physicians and pharmacists access to important medicines to improve the quality of patients’ lives around the world.”
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 two 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 Clinigen Group
Clinigen Group plc (AIM: CLIN) 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 now has over 1,100 employees across five continents in 14 countries, with supply and distribution hubs and operational centres 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, shipping approximately 6.4 million units in the year.
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.
Clinigen Group plc
James Winterman, Executive Vice President, Unlicensed Medicines
+44 (0) 1283 495010
Melanie Toyne-Sewell / Phillip Marriage / Nathan Billis
+44 (0) 20 7457 2020
Keywords: Adult; Child; Humans; Diabetes Mellitus; Glucagon; Blood Glucose; Hypoglycemia; Physicians; Pharmacy; Pharmacists; Disease Management
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