A. Menarini Asia-Pacific Holdings Pte. Ltd., and SciClone Pharmaceuticals (Holdings) Limited have entered into an exclusive licensing agreement to develop and commercialize Vaborem (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 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 is a fixed dose combination of a carbapenem and a novel boronic acid ß-lactamase inhibitor of class A and class C serine ß-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. 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.

To facilitate access to patients in China, SciClone will conduct local clinical trials and pursue applicable regulatory filings approvals in China.