CHICAGO & DUBLIN – (BUSINESS WIRE) – 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, announced today that the UK Medicines and Healthcare Regulatory Authority (MHRA) has the Ogluo® (glucagon) injection is approved for the treatment of severe hypoglycaemia in adults, adolescents and children aged 2 years and over with diabetes mellitus.
In February, the European Commission approved Ogluo. Since the EC decision was received after the end of the Brexit transition period, Xeris had to take another administrative step in order to obtain a license in Great Britain. No re-examination of clinical data by MHRA was required. The marketing authorization is valid in the United Kingdom, all 27 countries of the European Union, Iceland, Norway and Liechtenstein.
As previously mentioned, the company is actively seeking a partner to market Ogluo in the UK, EU and other regions. The start of the fourth quarter of 2021 is planned in selected EU countries.
ABOUT GVOKE / OGLUO
Gvoke® PFS and Gvoke HypoPen® (Glucagon Injection), the first prescription, ready-to-use, premixed, premeasured glucagon injection were approved by the FDA for use in the United States in September 2019. Gvoke is indicated for the treatment of severe hypoglycaemia in pediatric and adult patients with diabetes aged 2 years and over. Ogluo received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in December 2020 and the European Commission (EC) granted marketing authorization on February 11, 2021. Ogluo is indicated for the treatment of severe conditions hypoglycaemia in adults, adolescents and children 2 years and older with diabetes mellitus.
DISPLAY AND IMPORTANT SAFETY INFORMATION FOR GMOES
Gvoke is indicated for the treatment of severe hypoglycaemia in adult and pediatric patients with diabetes aged 2 years and over.
IMPORTANT SAFETY INFORMATION
Contraindications
Gvoke is contraindicated in patients with pheochromocytoma, insulinoma, and known hypersensitivity to glucagon or any of the excipients in Gvoke. Allergic reactions have been reported with glucagon and include anaphylactic shock with difficulty breathing and hypotension.
Warnings and Precautions
Gvoke is contraindicated in patients with pheochromocytoma because glucagon can stimulate the release of catecholamines from the tumor. If the patient develops a dramatic rise in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate given intravenously has been shown to be effective in lowering blood pressure.
In patients with insulinoma, administration of glucagon may cause an initial increase in blood sugar. However, administration of Gvoke can directly or indirectly (through an initial rise in blood sugar) stimulate excessive release of insulin from an insulinoma and cause hypoglycemia. Gvoke is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycemia after a dose of Gvoke, give glucose orally or intravenously.
Allergic reactions have been reported with glucagon. These include a generalized rash and, in some cases, anaphylactic shock with difficulty breathing and hypotension. Gvoke is contraindicated in patients with a previous hypersensitivity reaction.
Gvoke is only effective in treating hypoglycemia when there is sufficient hepatic glycogen. Hungry patients with adrenal insufficiency or chronic hypoglycemia may not have sufficient liver glycogen levels for Gvoke administration to be effective. Patients with these conditions should be treated with glucose.
Necrolytic migration erythema (NME), a rash often associated with glucagonomas, has been reported post-marketed after continuous infusion of glucagon and resolved with glucagon discontinuation. Should NME occur, determine whether the benefits of continuous infusion of glucagon outweigh the risks. Glucagon given to patients with glucagonoma can cause secondary hypoglycaemia.
Side effects
The most common (≥5%) side effects associated with Gvoke are nausea, vomiting, injection site edema (increased by 1 mm or more) and hypoglycaemia.
Drug interactions
Patients taking beta blockers may experience temporary increases in heart rate and blood pressure while taking OGLUO. In patients taking indomethacin, Gvoke may lose its ability to increase blood sugar or even cause hypoglycemia. Gvoke may increase the anticoagulant effects of warfarin.
Full prescribing information for Gvoke is available at www.xerispharma.com. Manufactured for Xeris Pharmaceuticals, Inc. by Pyramid Laboratories Inc., Costa Mesa, CA 92626.
About glucagon
Glucagon is a metabolic hormone secreted by the pancreas that increases blood sugar levels by causing the liver to quickly convert glycogen (the stored form of glucose) into glucose, which is then released into the bloodstream. Glucagon and insulin are two important hormones in a blood sugar control system that keep blood sugar at the right level in healthy individuals. In people with diabetes who depend on insulin, this control system is disturbed and insulin must be injected to avoid high blood sugar levels (hyperglycaemia). The opposite effect, or low blood sugar (hypoglycemia), is also widespread in this population due to impaired glucagon secretion. Severe hypoglycemia is a serious condition and can lead to seizures, coma, possible brain injury, and, if left untreated, death.
Glucagon is the standard for the treatment of severe hypoglycemia. According to the American Diabetes Association, glucagon should be prescribed to all individuals at increased risk of clinically significant hypoglycemia, defined as blood sugar <54 mg / dL (3.0 mmol / L). By leveraging XeriSol ™, one of Xeris' two proprietary formulation technology platforms, Xeris can provide the first ready-to-use, room temperature stable liquid glucagon for people with diabetes and other conditions to prevent or treat various forms of Xeris hypoglycemia and improve glucose control.
About severe hypoglycemia
Hypoglycemic events of any severity are a daily problem for people with diabetes. Mild or moderate hypoglycemia can occur several times a month. Severe hypoglycemia is characterized by severe cognitive impairment that requires external assistance for recovery and can be extremely frightening for patients and caregivers. Severe hypoglycemia can lead to cardiovascular disease, seizures, coma and, if left untreated, death. These severe hypoglycemic events can occur several times a year. Such events require emergency assistance from another person or carer, such as a family member, friend, or co-worker.
About Xeris Pharmaceuticals, Inc.
Xeris (Nasdaq: XERS) is a specialty pharmaceutical company providing innovative solutions to simplify the experience delivering critical therapies that people around the world rely on every day. With a novel technology platform enabling ready-to-use, room temperature stable formulations of injectable and infusible therapies, the company is expanding a portfolio of solutions in various therapeutic categories, including its first commercial US product, Gvoke®. Proprietary XeriSol ™ and XeriJect ™ formulation technologies have the potential to offer significant advantages over traditional product formulations, including eliminating the need for reconstitution, allowing long-term stability at room temperature, significantly reducing injection volume and eliminating the need for an intravenous route (IV) infusion. Xeris technology aims to make new product formulations easier for patients, caregivers and physicians to use and reduce costs for payers and the healthcare system.
Xeris is headquartered in Chicago, IL. For more information, please visit www.xerispharma.com or follow us on Twitter, LinkedIn or Instagram.
Forward-Looking Statements
All statements in this press release about future expectations, plans, and prospects for Xeris Pharmaceuticals, Inc., including statements about the market and therapeutic potential of its products and product candidates, expectations about clinical data, or results from planned clinical trials, when or the likelihood of regulatory approvals Approve and market its product candidates, the timing or likelihood of expansion into additional markets, the timing or likelihood of identifying potential development and commercialization partnerships, the potential benefits of its formulation platforms, and other statements that contain the words “will”. “” continue “and similar expressions would constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from those expressed in such forward-looking statements, including, without limitation, the effect of COVID -19 in relation to its business operations, reliance on third party vendors for Gvoke® and Ogluo®, regulatory approval of its product candidates, ability to market and sell its products if approved, and other factors set out in the “Risk Factors” section of the Quarterly Report on Form 10-Q last filed with the Securities and Exchange Commission and discussion of potential risks, uncertainties, and other important factors in subsequent filings by Xeris with the Securities and Exchange Commission, all contained in this press release Forward-looking statements speak only as of the date of this press release, and Xeris expressly disclaims any obligation to update any forward-looking statements as a result of new information, future events, or otherwise.
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