Everest Medicines Announces Acceptance of New Drug Application by China NMPA for Xerava(TM) for the Treatment of Complicated Intra-abdominal Infections
SHANGHAI, March 22, 2021 /PRNewswire/ — Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced today that the China National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for Xerava™ (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) in patients in China.
Xerava™ is a novel, fully synthetic, broad-spectrum parenteral antibiotic of the tetracycline class. It was approved for the treatment of cIAI in adults in Singapore in April 2020 and is currently approved for the treatment of cIAI in the US and EU.
"This marks the first NDA submission in China for Everest Medicines, representing an important step forward in our infectious disease clinical program, as well as our overall corporate mission to advance innovative and first-in-class medicines for patients in Greater China and other parts of Asia," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "We remain committed to rapidly progressing clinical development of important treatments, like Xerava™ , for patients in the region and look forward to our first potential product approval in China."
In September 2020, Xerava™ was included in the Infectious Disease Society of America’s (IDSA) updated clinical guidelines on the treatment of antimicrobial resistant gram-negative infections and in March 2021, it was included in an expert consensus on the multidisciplinary management of intra-abdominal infections by the Chinese Society of Surgery of Chinese Medical Association, Infectious Diseases Society for Evidence-based and Chinese Research Hospital Association and the Editorial Board of Chinese Journal of Surgery.
Under a licensing agreement with Tetraphase Pharmaceuticals (now a wholly owned subsidiary of La Jolla Pharmaceutical Company), Everest Medicines has exclusive rights to develop and commercialize Xerava™ in Greater China, South Korea, and the key markets of South East Asia, including Indonesia, Malaysia, Philippines, Thailand, Singapore and Vietnam.
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, with increasing rates of infections caused by drug-resistant bacteria, which limits the effectiveness of currently available antibiotics.
About Xerava™ (eravacycline)
Xerava™ is a novel, fully synthetic, broad-spectrum 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 and EU. The Company received approval in Singapore for eravacycline in cIAI in April 2020. Xerava™ was licensed from Tetraphase Pharmaceuticals, now a wholly owned subsidiary of La Jolla Pharmaceutical Company. For more information, please visit https://www.xerava.com/.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company’s therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com.
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