Research & Development
Xeris Pharmaceuticals Enters Into an Exclusive License and Supply Agreement with Tetris Pharma to Commercialize Ogluo in Europe
19 July 2021 - - US-based specialty pharmaceutical company Xeris Pharmaceuticals, Inc. (NASDAQ: XERS) has inked an exclusive agreement with UK-based 'niche speciality' pharmaceutical company Tetris Pharma Ltd. for the commercialization of Ogluo in the European Economic Area, United Kingdom, and Switzerland for the treatment of severe hypoglycaemia in adults, adolescents, and children aged two years and over with diabetes mellitus, the company said.

Under the terms of the applicable agreements, Xeris will be responsible for product supply and Tetris will be responsible for the commercialization of Ogluo in the Territory.

Subject to the terms and conditions set forth in the agreements, Xeris will receive up to USD 71m in payments tied to the first commercial sale and other time-, launch- and sales-related milestones and collect a royalty on net sales.

Xeris estimates there are more than five m patients on insulin and at risk of severe hypoglycaemia in the Territory, with only an estimated 10-20% having a prescription for glucagon.

Gvoke PFS and Gvoke HypoPen (glucagon injection), the first prescription, ready-to-use, pre-mixed, pre-measured glucagon injection, were approved by the FDA in September 2019 for use in the United States.

Gvoke is indicated for the treatment of severe hypoglycaemia in paediatric and adult patients with diabetes ages 2 years and above.

Ogluo received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in December 2020 and the European Commission granted the marketing authorisation on 11 February 2021.

The United Kingdom's Medicines and Healthcare products Regulatory Agency approved Ogluo (glucagon) injection on April 29, 2021. Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.

Gvoke is indicated for the treatment of severe hypoglycaemia in adult and paediatric patients with diabetes ages 2 years and above.

Gvoke is contraindicated in patients with pheochromocytoma, insulinoma, and known hypersensitivity to glucagon or to any of the excipients in Gvoke.

Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension.

Gvoke is contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumour.

If the patient develops a dramatic increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.

In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, Gvoke administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycaemia.

Gvoke is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycaemia after a dose of Gvoke, give glucose orally or intravenously.

Allergic reactions have been reported with glucagon. These include generalized rash, and in some cases, anaphylactic shock with breathing difficulties and hypotension. Gvoke is contraindicated in patients with a prior hypersensitivity reaction.

Gvoke is effective in treating hypoglycaemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycaemia, may not have adequate levels of hepatic glycogen for Gvoke administration to be effective.

Patients with these conditions should be treated with glucose.

Necrolytic migratory erythema, a skin rash commonly associated with glucagonomas, has been reported post-marketing following continuous glucagon infusion and resolved with discontinuation of the glucagon.

Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks. Glucagon administered to patients with glucagonoma may cause secondary hypoglycaemia.

Most common adverse reactions associated with Gvoke are nausea, vomiting, injection site edema (raised 1 mm or greater), and hypoglycaemia.

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given Ogluo.

In patients taking indomethacin, Gvoke may lose its ability to raise blood glucose or may even produce hypoglycaemia. Gvoke may increase the anticoagulant effect of warfarin.

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 (hypoglycaemia), is also prevalent in this population due to dysregulated glucagon secretion.

Severe hypoglycaemia is a serious condition and can lead to seizures, coma, potential brain injury and, if untreated, death.

Glucagon is the standard of care for treating severe hypoglycaemia. According to the American Diabetes Association, glucagon should be prescribed for all individuals at increased risk of clinically significant hypoglycaemia, defined as blood glucose
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