Clinigen Group has signed an exclusive agreement with Xeris Pharmaceuticals to manage the supply and distribution of Gvoke 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.
“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,” James Winterman, Executive Vice President of Unlicensed Medicines, Clinigen, said.