Endo Announces Agreement with MAIA Pharmaceuticals to Distribute Bivalirudin Injection in Ready-to-Use Vials

2023-05-24

Only ready-to-use (RTU) liquid format of bivalirudin expected to begin shipping in summer 2023 RTU bivalirudin injection does not require reconstitution, dilution or mixing, which helps increase efficiency for hospitals and healthcare providers DUBLIN, May 24, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that its subsidiary Endo Ventures Limited has executed an agreement with MAIA Pharmaceuticals, Inc. to distribute bivalirudin injection in a ready-to-use 250 mg/50 mL single-use vial in the U.S. Endo will commercialize the FDA-approved product through its Par Sterile Products business and expects to begin shipping in summer 2023. "Hospital providers have told us what they need—ready-to-use medications that allow them to focus on patients rather than preparation," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "Through this partnership with MAIA Pharmaceuticals, we are proud to answer that call with the only ready-to-use liquid format of bivalirudin." "Like Endo, MAIA is laser-focused on delivering meaningful solutions to support healthcare providers as they deliver quality patient care," said Brian Cooney, Sr. Director, Corporate Development at MAIA Pharmaceuticals. "We are pleased to partner with Endo to provide ready-to-use bivalirudin, which requires no reconstitution, no dilution and no mixing." Ready-to-use, or RTU, products streamline operations for hospitals by eliminating the need to prepare or transfer the product before patient administration. This may reduce waste and costs, optimize convenience and workflow and reduce the chance for preparation error—all of which support quality patient care. About Endo Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at or connect with us on LinkedIn. About MAIA Pharmaceuticals Founded in 2013 and headquartered in Princeton, New Jersey, MAIA Pharmaceuticals is a specialty pharmaceutical company that identifies, develops, manufactures and markets innovative and niche generic products. Cautionary Note Regarding Forward-Looking Statements Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation including, but not limited to, the statements by Messrs. Sims and Cooney, any statements relating to product launch, commercialization, sales, supply or distribution, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "intend," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect the Company's current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the outcome of the Company's contingency planning and restructuring activities; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust related matters; any actual or contingent liabilities; settlement discussions or negotiations; the Company's liquidity, financial performance, cash position and operations; the risks and uncertainties associated with chapter 11 proceedings; the time, terms and ability to confirm a sale of the Company's businesses under Section 363 of the U.S. Bankruptcy Code; the risk that the Company's chapter 11 cases may be converted to cases under chapter 7 of the Bankruptcy Code; the adequacy of the capital resources of the Company's businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company's businesses; the unpredictability of the Company's financial results; the Company's ability to discharge claims in chapter 11 proceedings; negotiations with the holders of the Company's indebtedness and its trade creditors and other significant creditors; the risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in chapter 11 proceedings; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; and the Company's ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by the Company, as well as the Company's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission. Company Codes: OTC-BB:ENDPQ, OTC-PINK:ENDPQ, OtherOTC:ENDPQ