Vaborem®a proprietary combination of meropenem and vaborbactam, is expected to treat the growing prevalence of carbapenem-resistant Klebsiella pneumoniae (CRKP) infections in China
The agreement combines the innovation of Melinta, the cross-regional expertise of Menarini in the registration and commercialization of this asset, and the development and commercial presence of SciClone in China
Menarini will receive a total payment of up to €115 million, which includes milestone payments and tiered royalties on net sales, over the term
SINGAPORE, September 20, 2022 /PRNewswire/ — A. Menarini Asia-Pacific Holdings Pte. Ltd., part of the Menarini Group, and SciClone Pharmaceuticals (Holdings) Limited have entered into an exclusive license agreement to develop and commercialize Vaborem® (meropenem and vaborbactam) in the People’s Republic of China (China). This initiative serves to expand options for addressing the public health threat of antimicrobial resistant infections, particularly carbapenem-resistant Enterobacteriaceae (CRE). Currently, Vaborem® is used to treat patients in the European Union for a variety of indications, including complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI) and hospital acquired pneumonia (PAH) and is approved in The United States of America to treat ITUc.
Vaborem® is a fixed dose combination of a carbapenem and a novel boronic acid β-lactamase inhibitor of class A and class C serine β-lactamases. It protects meropenem from degradation by serine carbapenemases, restoring its activity against carbapenem-resistant strains and has been specifically developed to inhibit CRE, including the commonly found carbapenemase-producing bacterium Klebsiella pneumoniae (KPC).
CRE infections, which have become a serious concern worldwide, have been listed by the World Health Organization as one of three critical pathogens requiring new antimicrobial options. These infections are currently associated with high mortality rates as well as increased length and cost of hospitalization. According to the China Antimicrobial Surveillance Network (CHINET), the incidence of carbapenem-resistant Klebsiella pneumoniae (CRKP) infections has increased sharply over the past 10 years. Currently, there are few drugs available for CRE infections, and existing treatments are often associated with significant toxicities and suboptimal pharmacokinetics.
“We are delighted to partner with Menarini to develop and commercialize Vaborem® in China and bring better treatment options to patients with serious illnesses. This partnership recognizes SciClone’s capabilities in product development and commercialization and also helps us solidify our strategic focus on infectious diseases. We are keen to work with overseas partners to introduce international and advanced treatment options in China and to provide patients around the world with our own innovative, high-quality medicines,” said Hong ZhaoPresident and CEO of SciClone.
Under the licensing agreement, Menarini will receive payments consisting of milestones and tiered royalties on sales. SciClone will be responsible for driving and funding local clinical development and commercialization of Vaborem®. To facilitate patient access ChinaSciClone will conduct local clinical trials and pursue applicable regulatory filing approvals in China.
“This is an important step for Menarini to continue providing patients with treatments for life-threatening conditions. The collaboration with SciClone will facilitate better access to anti-infective drugs and address the growing threat of antimicrobial resistance. focused goals shared with Melinta,” said Maurizio Luongo, Managing Director of Menarini Asia-Pacific. “Menarini will continue to enhance its offerings by sourcing innovative assets and expanding its geographic coverage through both direct presence and external partnerships,” he added.
Menarini acquired the exclusive rights from Melinta in 2018 to market and sell Vaborem® (meropenem and vaborbactam) in 68 countries in EuropeCommonwealth of Independent States and Asia-Pacific.
“Our mission is to provide innovative therapies to people affected by acute and life-threatening illnesses. We are delighted that our first-class product, through our collaboration with Menarini, is well positioned to help make a difference for patients in China who need our therapy,” said Christine Anne MillerPresident and CEO of Melinta Therapeutics.
About Menarini Asia Pacific
Menarini Asia-Pacific is part of the Menarini Group, the world’s largest Italian biopharmaceutical company with a heritage of over 135 years and over 17,000 employees in over 140 countries. In Asia Pacific, Menarini has a direct presence in 13 major healthcare markets with over 3,500 employees and strives to be a leading provider of healthcare solutions and services to reinvigorate lives. Menarini Asia-Pacific operates across the entire value chain including clinical development, regulatory activity, marketing and sales with a diverse portfolio of proprietary and partner brands in consumer healthcare and prescription drugs. For more information on Menarini Asia-Pacific, please visit: https://www.menariniapac.com/
About SciClone Pharmaceuticals
SciClone Pharmaceuticals (Holdings) Limited (“SciClone Pharmaceuticals”, HKEX: 6600) is a global biopharmaceutical company with an integrated platform for the development and commercialization of innovative therapies for cancer and serious infections. With a strategic transformation focused on innovation, SciClone Pharmaceuticals has established a product portfolio with differentiated advantages, including a number of potential first-class and first-class products/pipelines. True to the Group’s original aspiration of “Sciclone gives hope for life”, SciClone is dedicated to improving the health of patients by providing leading healthcare products and services with standards of global care. For more information on SciClone, please visit: http://www.sciclone.com/
About Melinta Therapeutics
Melinta Therapeutics, LLC provides innovative therapies for people affected by acute and life-threatening illnesses. Our portfolio currently includes six commercial-stage products: Baxdela® (delafloxacin), Kimyrsa® (oritavancin), Minocin® (minocycline) for injection, Orbactiv® (oritavancin), TOPROL-XL® (metoprolol succinate) and Vabomere® (meropenem and vaborbactam). Melinta has also entered into a license agreement with Cidara Therapeutics securing the rights to commercialize and distribute development candidate rezafungin in United States.
With an unparalleled commitment to providers and the patients they serve, Melinta ensures that everyone who needs their therapies can receive them. Melinta focuses its expanding portfolio on serving patients with unmet need to have the most significant impact. Melinta is dedicated to innovation while remaining rooted in what matters most: patients. For more information on Melinta, please visit: https://melinta.com/
SOURCE A. Menarini Asia-Pacific Holdings Pte. ltd.