SHANGHAI, Sept. 20, 2023 /PRNewswire/ — Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing, manufacturing, and commercializing transformative pharmaceutical products and vaccines in Greater China and other parts of Asia, announced today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recommended Priority Review for cefepime-taniborbactam for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, based on the criteria of “innovative drugs for the prevention and treatment of major infectious diseases and rare diseases that meet urgent clinical needs.”
“Currently, the clinical challenges from multi-drug resistant infections are severe. The recommendation of priority review by CDE for cefepime-taniborbactam underscores the important clinical value of the medicine. It shows that cefepime-taniborbactam has a clinical advantage to address urgent and unmet medical needs in China. We will work closely with the Regulatory Agency to bring this innovative medicine to Chinese patients as quickly as possible,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “Our leading product in the infectious disease space XERAVA® has commercially launched in China. Cefepime-taniborbactam will strengthen Everest’s infectious disease portfolio, which is a key therapeutic area that will help drive our future growth.”
Our partner Venatorx Pharmaceuticals announced in August that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for cefepime-taniborbactam and granted Priority Review of the NDA with a Prescription Drug User Fee Act (PDUFA) target action date of Feb. 22, 2024. The cefepime-taniborbactam NDA filing was supported by results from the pivotal Phase 3 study, CERTAIN-1, evaluating the efficacy and safety of cefepime-taniborbactam compared to meropenem in adults with cUTI, including acute pyelonephritis. Cefepime-taniborbactam was superior to meropenem for the primary efficacy endpoint of composite microbiologic and clinical success at the Test of Cure (TOC) visit (Day 19-23) in the microbiological intent-to-treat (microITT) population. Cefepime-taniborbactam was well-tolerated and no new safety findings were identified.
Cefepime-taniborbactam is an investigational intravenous (IV) beta-lactam/beta-lactamase inhibitor antibiotic being developed by Venatorx Pharmaceuticals for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis.
Cefepime, a fourth-generation cephalosporin, is a widely used beta-lactam (BL) antibiotic with more than two decades of proven safety and clinical utility against susceptible gram-negative and gram-positive bacteria. Taniborbactam is a beta-lactamase inhibitor (BLI) that, in combination with cefepime, may offer a potential treatment option for patients with serious infections caused by difficult-to-treat resistant gram-negative bacteria, most notably carbapenem-resistant Enterobacterales (CRE) and carbapenem-resistant Pseudomonas aeruginosa (CRPA). Many of these organisms are also multidrug-resistant (MDR), further limiting treatment options. Cefepime-taniborbactam has been granted Qualified Infectious Disease Product (QIDP), Fast Track designation, and Priority Review by the U.S. Food and Drug Administration.
Under an exclusive licensing agreement with Venatorx Pharmaceuticals, Everest Medicines has the rights to develop and commercialize cefepime-taniborbactam in Greater China, South Korea, and some southeast Asian countries.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing, manufacturing, and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development, and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal diseases, infectious diseases, and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.
This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief, or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal, and social conditions. The Company or any of its affiliates, directors, officers, advisors, or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events, or circumstances after the date of this news release, except as required by law.