Chicago-based Xeris designed Ogluo (Gvoke PFS and Gvoke HypoPen in the U.S.) to be a ready-to-use, pre-mixed, pre-measured glucagon injection for treating severe hypoglycemia in adults, adolescents and children two years of age and older with diabetes mellitus.
Ogluo received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2020 before the European Commission granted marketing authorization on Feb. 11, 2021. The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Ogluo on April 29 of this year.
Under the commercialization agreement, Xeris will be responsible for product supply and Tetris will be responsible for commercializing Ogluo in a territory comprised of the European economic area, the United Kingdom and Switzerland, according to a news release.
Subject to terms and conditions set forward, Xeris will receive up to $71 million in payments tied to the first commercial sale and other time-, launch- and sales-related milestones while collecting a royalty on net sales.
“We were seeking and found, in Tetris, a partner for whom success with Ogluo would be absolutely critical to their European expansion and to their future as a company. We also are excited by their entrepreneurial approach and understanding of the importance of ready-to-use glucagon and specifically, how Ogluo can impact the lives of patients and caregivers,” Xeris chairman & CEO Paul R. Edick said in the release. “Like in the U.S., very few diabetes patients on insulin in the EU and UK have glucagon on hand in case of a severe hypoglycemia event. The Tetris team is dedicated to getting Ogluo in the hands of patients on insulin.”
Tetris Pharma CEO Shafiq Choudhary added that the company expects to launch Ogluo in the UK by the end of the year before launching in at least seven additional countries by mid-2022.
“We are delighted to have acquired the pan-European license for Ogluo, a ready-to-use auto-injector of glucagon to help rescue patients from the debilitating and potentially life-threatening consequences of severe hypoglycemia,” Choudhary said. “As the incidence and prevalence of diabetes continues to rise globally, we are committed to bringing this important and ready-to-use product to patients at risk of suffering from severe low blood sugar levels.”