PR97843

SINGAPORE, Sept. 20, 2022 /PRNewswire=KYODO JBN/ --

•        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/ -- 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

Beta lactamase inhibitor of class A and class C serine Beta 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.