[PRNewswire] Menarini and SciClone Sign Exclusive Licensing Agreement to

Develop and Commercialize Vaborem(R) in China to Treat Antimicrobial Resistant Infections

- Vaborem(R), a patented combination of meropenem and vaborbactam, is expected to address the rising prevalence of carbapenem-resistant Klebsiella pneumoniae (CRKP) infections in China

- The deal brings together Melinta's innovation, Menarini's cross-regional expertise in registration and marketing this asset, and SciClone's development and commercial presence in China

- Menarini will receive a total payment of up to €115 million, which includes milestone payments and tiered royalty on net sales, during the term

(SINGAPORE, Sept. 20, 2022 PRNewswire=연합뉴스) A. Menarini Asia-Pacific Holdings Pte. Ltd., part of The Menarini Group, and SciClone Pharmaceuticals (Holdings) Limited have entered into an exclusive licensing agreement to develop and commercialize Vaborem(R) (meropenem and vaborbactam) in the People's Republic of China (China). This initiative serves to expand options to address the public health threat of antimicrobial resistant infections, specifically carbapenem-resistant Enterobacterales (CRE). Currently, Vaborem(R) is being 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 (HAP) and is approved in the United States of America to treat cUTI.

Vaborem(R) 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 Klebsiella pneumoniae Carbapenemase (KPC)-producing bacteria.

CRE infections, which have become a serious concern worldwide, have been listed by the World Health Organization as one of the three critical pathogens in need of new antimicrobial options. These infections are currently associated with high rates of mortality as well as increased length of hospital stay and costs. According to China Antimicrobial Surveillance Network (CHINET), the incidence of carbapenem-resistant Klebsiella pneumoniae (CRKP) infections has experienced a steep increase in the last 10 years. As of now, there are few drugs available against CRE infections, and existing treatments are often associated with significant toxicities and suboptimal pharmacokinetic parameters.

"We are excited to partner with Menarini to develop and commercialize Vaborem(R) in China and bring better treatment options to patients with severe ailments. This partnership recognizes SciClone's capabilities in product development and commercialization and also helps us consolidate our strategic focus on infectious diseases. We are keen on working with overseas partners to introduce international and advanced treatment options in China and to provide patients around the world with our own high-quality innovative drugs," said Hong Zhao, President and Chief Executive Officer of SciClone.

Under the License Agreement, Menarini will receive payments including milestones and tiered royalty on sales. SciClone will be responsible for conducting and funding local clinical development as well as commercialization of Vaborem(R). To facilitate access to patients in China, SciClone will conduct local clinical trials and pursue applicable regulatory filings approvals in China.

"This is an important step for Menarini to further provide patients with treatments for life-threatening conditions. The collaboration with SciClone will facilitate greater access to anti-infective medicines and address the rising threat of anti-microbial resistance. It also reflects the patient-centric goals shared with Melinta," said Maurizio Luongo, Chief Executive Officer of Menarini Asia-Pacific. "Menarini will continue to enhance its offerings by sourcing innovative assets and to expand its geographical coverage by both direct presence and external partnerships," he added.

Menarini acquired the exclusive rights from Melinta in 2018 to market and sell Vaborem(R) (meropenem and vaborbactam) in 68 countries in Europe, the Commonwealth of Independent States and Asia-Pacific.

"Our mission is to provide innovative therapies to people impacted by acute and life-threatening illnesses. We are pleased that our first-in-class product, through our collaboration with Menarini, is well positioned to help make a difference for those patients in China who need our therapy," said Christine Ann Miller, President and Chief Executive Officer of Melinta Therapeutics.

About Menarini Asia-Pacific

Menarini Asia-Pacific is a 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 more than 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 invigorate lives. Menarini Asia-Pacific, operates across the value chain, including clinical development, regulatory activity, marketing and sales with a diverse portfolio of proprietary and partnered brands in consumer health and prescription medicines. For additional information regarding 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 severe infection. With an innovation-driven strategic transformation, SciClone Pharmaceuticals has established a product portfolio with differentiated advantages, including a number of first-in-class and best-in-class potential products/pipelines. Staying true to the Group's original aspiration of "Sciclone gives life hope", SciClone is dedicated to improving patients' health by providing top-tier healthcare products and services with global standards of care. For more information regarding SciClone, please visit: http://www.sciclone.com/

About Melinta Therapeutics

Melinta Therapeutics, LLC provides innovative therapies to people impacted by acute and life-threatening illnesses. Our portfolio currently includes six commercial-stage products: Baxdela(R) (delafloxacin), Kimyrsa(R) (oritavancin), Minocin(R) (minocycline) for Injection, Orbactiv(R) (oritavancin), TOPROL-XL(R) (metoprolol succinate) and Vabomere(R) (meropenem and vaborbactam). Melinta also has a licensing agreement in place with Cidara Therapeutics securing the rights to market and distribute development candidate rezafungin in the United States.

With an unsurpassed commitment to providers and the patients they serve, Melinta works to ensure that all people who need their therapies can receive them. Melinta focuses its expanding portfolio on serving patients with an unmet need to make the most meaningful impact. Melinta is dedicated to innovation while staying grounded in what matters most: patients. For additional information regarding Melinta, please visit: https://melinta.com/

Source: A. Menarini Asia-Pacific Holdings Pte. Ltd.

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