Xeris’ Pharmaceuticals Glucagon Progresses Towards FDA Approval

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Xeris Pharmaceuticals, Inc. (“Xeris”) recently announced successful completion of both adult and pediatric clinical studies for its glucagon rescue pen. According to Xeris’ President and CEO Paul Edick:

Xeris is on-track to submit an NDA for our ready-to-use glucagon rescue pen for the treatment of severe hypoglycemia in late Q2 of this year.  We will use the data from the Phase 3b study to gain additional information regarding the entire treatment episode, including preparation and administration time of the current glucagon emergency kits versus our rescue pen auto-injector, for people with diabetes who may require glucagon in emergency situations.

Xeris also recently released results from a Human Factors usability and reliability study which, according to Xeris, demonstrated a 99% success rate for patients in administering full doses of glucagon with the rescue pen using a simple 2-step process.

Xeris notes that glucagon treatment is critical for persons susceptible to severe hypoglycemic events. Severe hypoglycemia, if untreated, can result in seizures, coma, brain damage, and if left unaddressed, even death. Along with insulin, glucagon helps maintain the glycemic control system which in turn keeps blood glucose at optimum levels within the body. The American Diabetes Association recommends glucagon be prescribed for persons facing increased risks of hypoglycemia. According to Xeris, due to limitations in current glucagon products and the difficulty involved in administration methods (especially in emergency situations), such treatments have been underutilized by persons at risk of suffering from severe hypoglycemic events.

According to Xeris, their rescue pen aims to provide ready-to-use, room-temperature stable, and injectable and infusible drug formulations. Xeris’ proprietary XeriSolTM and XeriJectTM formulations are currently being examined for administration in both subcutaneous and intramuscular delivery sites. Xeris states that unlike some injectable drug formulations provided as a powder that is later reconstituted with water at the time of administration, Xeris’ formulations are non-aqueous, ultra-concentrated and ultra-low volume, biocompatible solutions or pastes. Xeris also reports that their formulations are packaged in a ready-to-use compatible syringe, such as its rescue pen auto-injector, or other compatible devices, such as vials, pens, or pumps. 

Aaron Johnson
Aaron S. Johnson is an associate in the firm's Orange County office. His practice includes patent prosecution, IP litigation, and due diligence. Aaron received his Bachelor of Science in Civil Engineering from the University of California, Irvine. Aaron later received his Master of Science degree in Civil Engineering from the University of California, Berkeley, specifically within the Structural Engineering, Mechanics, and Materials Department (SEMM). Aaron's master's thesis involved research and analysis of seismic base isolation systems. While at UC Berkeley, Aaron worked as a graduate student instructor for first-year students majoring in mechanical and civil engineering. After graduating, Aaron worked as a structural engineer and earned his professional engineer license. Aaron earned his law degree from the University of California, Irvine, where he served as a teaching assistant for a first-year Lawyering Skills course and as a research Editor on the UC Irvine Law Review. Aaron also worked at the UCI Intellectual Property, Arts, and Technology Clinic. Mr. Johnson worked as a summer associate in 2016 before joining the firm as an associate in 2017.
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