Melinta Therapeutics and Xediton Pharmaceuticals Announce Licensing Agreement to Commercialize Anti-Infective Products in Canada

2023-05-15
引进/卖出上市批准优先审批
PARSIPPANY, N.J. & OAKVILLE, Ontario--(BUSINESS WIRE)-- Melinta Therapeutics, LLC (Melinta) and Xediton Pharmaceuticals Inc (Xediton) today announced they have entered into an exclusive commercialization and licensing agreement for BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), ORBACTIV® (oritavancin) and VABOMERE® (meropenem and vaborbactam), four novel anti-infective products. Under the terms of the agreement, Xediton is responsible for the registration and commercialization of these products in Canada. “We are very pleased to partner with Melinta to bring these life-saving products to Canada. We believe these products will address unmet needs and will be of tremendous benefit to Canadian patients, particularly in our fight to combat the global threat of antimicrobial resistance. We look forward to the approval and commercialization of BAXDELA, KIMYRSA, ORBACTIV and VABOMERE,” said George Gafrey, President of Xediton. “These products have been approved by the United States Food and Drug Administration for indications that include the treatment of infections caused by organisms on Canada’s Pathogens of Interest List. This will make our subsequent submissions to Health Canada potentially eligible for Priority Review, an expedited regulatory pathway here in Canada.” “Xediton shares our commitment to ensure that all patients who need our life-saving therapies can get them,” said Christine Ann Miller, President and Chief Executive Officer of Melinta. “We’re thrilled to enter into this partnership with Xediton, a recognized leader in specialty care pharmaceuticals in Canada. We are confident that Xediton brings the right amount of energy and experience to effectively bring our novel anti-infective portfolio to market throughout this region. Xediton has built an impressive business model over the years in both registering and commercializing hospital-based products licensed from the US and we look forward to supporting their continued efforts for commercializing our portfolio as well.” About Melinta Therapeutics Melinta Therapeutics provides innovative therapies to people impacted by acute and life-threatening illnesses. Our portfolio currently includes six commercial-stage products: Baxdela® (delafloxacin), Kimyrsa® (oritavancin), Minocin® (minocycline) for Injection, Orbactiv® (oritavancin), RezzayoTM (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and Vabomere® (meropenem and vaborbactam).With an unsurpassed commitment to providers and the patients they serve, we work to ensure that all people who need our therapies can receive them. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. For additional information, including product and respective important safety information, please visit . About Xediton Pharmaceuticals Xediton Pharmaceuticals is a privately-held specialty pharmaceutical company with a focus on meeting the needs of patients, physicians and partners. Xediton Pharmaceuticals is committed to developing, partnering and making available new and established medicines to promote the health of Canadians. Located in the Greater Toronto Area, Canada, Xediton Pharmaceuticals has products in Oncology, Anti-Infectives, Pain, CNS, GI, Ophthalmology, Renal and CV and has built strong strategic alliances with Global and International Healthcare and pharmaceutical companies. For more information, please visit .
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