Everest Medicines Initiates Submission of New Drug Application in Hong Kong for XeravaTM for the Treatment of Complicated Intra-abdominal Infections

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Sep 29, 2021, 05:39 ET

SHANGHAI, Sept. 29, 2021 /PRNewswire/ -- Everest Medicines Limited (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asia, announced today the submission of a New Drug Application (NDA) to the Department of Health, the Hong Kong Special Administrative Region, China, for Xerava™ (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) in adult patients in Hong Kong.

"cIAI remains as a major bacterial infectious diseases in clinics and the increasing multi-drug resistance bacterial related infection presents a significant and growing public health concern in mainland China, Hong Kong and other parts of Asia with a limited choices of effective treatment options" said Sunny Zhu, Chief Medical Officer for Infectious Diseases at Everest Medicines. "We're excited to initiate this NDA submission for Xerava™ in Hong Kong to bring this new and innovative therapeutic option to patients. This submission has the potential to advance Xerava™ availability in the third regional territory for Everest, building on our previous approval in Singapore and ongoing review in mainland China."

Xerava™ is currently approved for the treatment of complicated intra-abdominal infections (cIAI) in the US, EU, UK and Singapore, and is currently under regulatory review for cIAI in mainland 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.

About Complicated Intra-Abdominal Infections

Complicated intra-abdominal infection (cIAI) is 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 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 and Singapore and the medicine is currently under review for cIAI in mainland China. Everest is also developing Xerava™ for the treatment of community-acquired bacterial pneumonia (CABP). 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 Asia 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 in Asia and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of ten 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.

SOURCE Everest Medicines