GVOKE Pre-Filled Syringe (PFS) is available for home delivery through PillPack by Amazon Pharmacy
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, reinforces the importance of Gvoke PFS for people with diabetes and encourages healthcare professionals to discuss having glucagon on hand with their at-risk patients.
“We know this is an incredibly tense time for all, and in particular, the diabetes community. Stress and erratic schedules increase the risk of a severe hypoglycemic event1-2. Given that the U.S. healthcare system is being overwhelmed with the COVID-19 crisis, access to hospitals may be limited in the event of severe low blood sugar requiring rescue. Therefore, people with diabetes need access to a ready-to-use glucagon option they can use correctly. Usability studies have demonstrated 99% of people, both trained and untrained, were able to use Gvoke pre-filled syringe successfully3,” said Paul R. Edick, Chairman and CEO. “The urgency of ensuring that all healthcare professionals are aware of the importance of Gvoke PFS, a liquid glucagon option that is prefilled, premixed and ready-to-use, is paramount.”
Mr. Edick continued, “We recognize the importance of making Gvoke easy and convenient to get, especially now. In addition to having Gvoke PFS available at the chain and local pharmacies, we have a home delivery option through PillPack by Amazon Pharmacy.”
Patients can request a prescription online, and pharmacists at PillPack by Amazon Pharmacy will reach out to their doctor for a prescription. Gvoke PFS will be shipped to their home at no additional cost, just the cost of their copay. Please note, currently this option is available for people with commercial insurance only. Learn more at https://www.gvokeglucagon.com/ordering-gvoke.
In response to the recommendations of the public health officials and government agencies, Xeris has quickly shifted from face‐to‐face interactions with healthcare professionals to virtual field calls and educational webinars for the next few weeks. This will allow Xeris to continue to service the needs of its customers in this critical time that people need easier access to glucagon, while helping reduce the spread of COVID‐19, preserve healthcare resources, and protect the health of our employees and their families.
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.
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.
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 2 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 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.
Any statements in this press release about future expectations, plans and prospects for Xeris Pharmaceuticals, Inc., including statements regarding the timing of the commercial launch of Gvoke HypoPen™, the availability of supply of Gvoke PFS for the balance of 2020, the availability of Gvoke PFS for home delivery, the acceptance of Gvoke™ in the marketplace, and other statements containing the words “plans”, “expects”, “anticipates”, "will," "would," "continue," and similar expressions constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, without limitation, the regulatory approval of its product candidates, its ability to market and sell its products, if approved, and other factors discussed in the "Risk Factors" section of the most recently filed Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in Xeris’ subsequent filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Xeris expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
The Company intends to use the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.
1. Kedia N. Diabetes Metabolic Syndrome and Obesity: Targets Therapy. 2011; 4:337-346. 2. Geller AI et al. JAMA Intern Med. 2014;174(5):678-686. 3. Brett Newswanger, Steven Prestrelski & Anthony D. Andre (2019) Human factors studies of a prefilled syringe with stable liquid glucagon in a simulated severe hypoglycemia rescue situation, Expert Opinion on Drug Delivery, 16:9, 1015-1025, 4. Frier BM. Nat Rev Endocrinol. 2014; 10:711–722. 5. American Diabetes AssociationDiabetes Care 2020; 43 (Suppl. 1): S66-S76.
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Senior Vice President, Investor Relations and Corporate Communications
Source: Xeris Pharmaceuticals, Inc.