Xeris Pharmaceuticals Reinforces the Importance of GVOKE PFS for People With Diabetes - Seite 2

As previously disclosed, Xeris has no business exposure to China. Regarding Gvoke PFS, the Company believes it has four to five months of finished goods on hand; four to five months of product currently being manufactured; and, an additional six to nine months of components and API. Therefore, the Company has commercial supply for the balance of 2020. In addition, the external components of Gvoke HypoPen, Xeris’ liquid glucagon in an autoinjector, are being manufactured in Taiwan with the cartridges made in the U.S. and final assembly to be in the U.S. To date, there have been no work interruptions of manufacturing of Gvoke HypoPen components in Taiwan.

About Severe Hypoglycemia

Hypoglycemic events of any severity are a daily concern for people with diabetes. Mild or moderate hypoglycemia can occur multiple times a month. Severe hypoglycemia is characterized by severe cognitive impairment, requiring external assistance for recovery, and can be extremely frightening for patients and caregivers. Severe hypoglycemia can result in cardiovascular disease, seizure, coma, and, if left untreated, death. These severe hypoglycemic events can occur multiple times a year. Such events require emergency assistance from another person or caregiver such as a family member, friend, or co-worker.

About Glucagon

Glucagon is a metabolic hormone secreted by the pancreas that raises blood glucose levels by causing the liver to rapidly convert glycogen (the stored form of glucose) into glucose, which is then released into the bloodstream. Glucagon and insulin are two critical hormones in a glycemic control system that keep blood glucose at the right level in healthy individuals. In people with diabetes who are dependent on insulin, this control system is disrupted, and insulin must be injected to avoid high levels of blood glucose (hyperglycemia). The opposite effect, or low blood glucose (hypoglycemia), is also prevalent in this population due to dysregulated glucagon secretion. Severe hypoglycemia is a serious condition and can lead to seizures, coma, potential brain injury and, if untreated, death⁴.

Glucagon is the standard of care for treating severe hypoglycemia. According to the American Diabetes Association⁵, glucagon should be prescribed for all individuals at increased risk of clinically significant hypoglycemia, defined as blood glucose <54 mg/dL (3.0 mmol/L). Leveraging XeriSol, one of Xeris’ two proprietary formulation technology platforms, Xeris has the potential to provide the first ready-to-use, room-temperature stable liquid glucagon for use by people with diabetes and other conditions to prevent or manage various forms of hypoglycemia and improve glucose control.