Xerava approval marks the first product to be commercialized by Everest in China
Everest plans to commercially launch Xerava in China in Q3, 2023
, March 16, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today that the National Medical Products Administration (NMPA) of China has approved its New Drug Application (NDA) for Xerava (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) in adult patients. The Company plans to commercially launch Xerava in China in the third quarter this year.
"We are very excited to receive NMPA approval for Xerava and launch the product as the first product Everest will commercialize in China," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "This will lead Everest's transformation from a biotech to a fully-integrated biopharmaceutical company. We expect to have three or more product approvals in 2023-2024, including Nefecon to be approved and commercialized later this year. Together with Xerava, these products will help Everest develop into a full commercial-stage company."
"The approval of Xerava by NMPA reinforces the importance of addressing the urgent need for innovative antibiotic treatment options in China as multidrug-resistant bacteria infection continues to pose clinical challenges in China," said Sunny Zhu, Chief Medical Officer for Infectious Diseases at Everest Medicines. "We are encouraged by the continued regulatory success of Xerava across our territories in Asia, demonstrating Everest's superior capabilities to effectively advance innovative treatment options on behalf of patients in need. In the infectious disease space, we have other best-in-class product candidates in the pipeline. We plan to file NDA for Taniborbactam in China this year for complicated urinary tract infection and we plan to initiate phase III clinical study in the second half of this year for EVER206, a novel polymyxin derivative with potentially better safety profile compared to current options. We hope to advance these two drug candidates quickly so that our portfolio of three innovative antibiotics could help address the significant unmet medical needs in China."
Xerava has been approved and commercialized in Singapore. It was also approved in Hong Kong and is currently under regulatory review for cIAI in the Taiwan region. Since 2020, Xerava has been recommended in multiple global treatment guidelines issued by Infectious Disease Society of America's (IDSA) and European Society of Clinical Microbiology and Infectious Diseases (ESCMID) as a treatment choice for multi-drug resistant gram-negative bacterial infections including Carbapenem resistant organisms. In addition, it was included in an expert consensus on the multi-disciplinary management of intra-abdominal infections by the Chinese Society of Surgery of Chinese Medical Association, Infectious Diseases Society for Evidence-based and Translational Medicine of Chinese Research Hospital Association and the Editorial Board of Chinese Journal of Surgery. In Feb. 2023, Xerava was also recommended in the Guidelines for the diagnosis, treatment, prevention and control of infections caused by carbapenem-resistant gram-negative bacilli.
"Xerava, with a broad bacterial spectrum coverage, shows high antibacterial potency in vitro, and has strong antibacterial activity against major clinical resistant pathogens such as ESBLs, CRE, CRAB, VRE, MRSA, etc.," said Professor Wang Minggui, head of the Institute of Antibiotics at Huashan Hospital affiliated to Fudan University. "Xerava has been recommended by many guidelines in China and abroad, and its domestic launch will definitely help the treatment of resistant pathogens' infections in China."
Everest Medicines has exclusive rights to develop and commercialize Xerava in Greater China, South Korea, and certain markets of South East Asia, under a licensing agreement with Tetraphase Pharmaceuticals, Inc. (a wholly owned subsidiary of Innoviva, Inc.).
About Xerava® (eravacycline)
Xerava® (eravacycline) is a novel, fully synthetic, broad-spectrum, fluorocycline, parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative and Gram-positive pathogens that have acquired multidrug resistance (MDR) and are prevalent in China. Xerava is currently approved for the treatment of complicated intra-abdominal infections (cIAI) in the US, EU, UK, Singapore and Hong Kong and the medicine is currently under review for cIAI in Taiwan region. Xerava was licensed from Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of Innoviva, Inc.
About Complicated Intra-Abdominal Infections
Complicated intra-abdominal infections (cIAI) are a type of major hospital- or community-acquired infection which extend beyond the source organ into the peritoneal space and can result from perforation of or damage to the gastrointestinal tract. cIAI diagnoses include intra-abdominal abscess, stomach or intestinal perforation, peritonitis, appendicitis, cholecystitis, or diverticulitis. cIAI is caused by different bacterial pathogens, including Gram-negative aerobic bacteria, Gram-positive bacteria, and anaerobic bacteria. In 2018, there were 2.9 million cIAI patients in China alone, with increasing rates of infections caused by drug-resistant bacteria, which limits the effectiveness of currently available antibiotics.
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.
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SOURCE Everest Medicines