CHICAGO--(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, today announced an exclusive agreement with Clinigen Group plc (AIM: CLIN, ‘Clinigen’) to manage the supply and distribution of Gvoke™ outside of the United States where Gvoke is not currently licensed.
“In an effort to make ready-to-use Gvoke as accessible as possible to people with diabetes and in response to requests while our MAA is under review with the EMA, we have partnered with Clinigen, a distributor of unlicensed medicines. With Clinigen’s global infrastructure and expertise in the distribution of important unlicensed medicines, we can enable people with diabetes around the world to access Gvoke,” said Paul R. Edick, Chairman and CEO of Xeris. “It is especially important during this global health crisis that people with diabetes, who the CDC and others have identified as an at-risk population, have access to medicines like Gvoke, which can enable them to self-treat and avoid going to a busy hospital or medical center to receive care.”
All Gvoke product requests must be submitted by the treating physician on behalf of the patient. Healthcare professionals can obtain details about the Gvoke Managed Access Program by calling the Clinigen customer service team at +44 (0) 1283 494 340 or emailing firstname.lastname@example.org. Patients seeking medical information should contact their physician. Learn more at https://www.gvokeglucagon.com/hcp.
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.
About Clinigen Group plc
Clinigen Group plc is a global pharmaceutical and services company with a unique combination of businesses focused on providing ethical access to medicines. Its mission is to deliver the right medicine to the right patient at the right time through three areas of global medicine supply: clinical trial, unlicensed and licensed medicines. The Group has sites in North America, Europe, Africa and Asia Pacific. Clinigen has over 1,100 employees across five continents in 14 countries, with supply and distribution hubs and operational centers of excellence in key long-term growth regions. The Group works with 22 of the top 25 pharmaceutical companies, interacting with over 15,000 registered users across over 100 countries, and shipping approximately 6.4 million units in the year. For more information on Clinigen, please visit www.clinigengroup.com.
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 Annual Report on Form 10-K 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.