Everest Medicines Announces Approval of Clinical Trial Application by China NMPA for Phase 3 Trial of Xerava(TM) for Community-Acquired Bacterial Pneumonia

Everest Medicines, 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 Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People's Republic of China has approved a Clinical Trial Application (CTA) for XeravaTM (eravacycline) for the treatment of community-acquired bacterial pneumonia (CABP). With this CTA, Everest Medicines plans to conduct a Phase 3 trial in China evaluating the efficacy and safety of eravacycline in treating adult patients with CABP.

Eravacycline is a novel, fully synthetic, broad-spectrum parenteral antibiotic of the tetracycline class. It is approved for the treatment of complicated intra-abdominal infections (cIAI) in the US and EU, was approved for the treatment of cIAI in adults in Singapore in April 2020 and is currently under regulatory review for cIAI in China.

"This approval allows us to advance the clinical development of eravacycline in lung infections in order to further enhance its clinical value for unmet medical needs in China and Asia," said Sunny Zhu, Chief Medical Officer for Infectious Diseases at Everest Medicines. "In 2019, there were 28.1 million cases of CABP in China. Lung infections present a major disease burden in China, while multi-drug resistant (MDR) bacterial infections remain a critical challenge in China and around the world. Eravacycline's in-vitro, in-vivo and clinical data obtained to date make a strong case for its therapeutic potential in CABP and other infectious disease areas. We look forward to initiating and progressing this Phase 3 trial as we work to bring this novel treatment to patients in China."

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 Community Acquired Bacterial Pneumonia 

CABP is defined as an acute bacterial infection of the pulmonary parenchyma associated with chest pain, cough, sputum production, difficulty breathing, chills, rigors, fever, or hypotension and is accompanied by the presence of a new lobar or multilobar infiltrate on a chest radiograph. Common typical bacterial pathogens that cause CABP include Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, and Moraxella catarrhalis as well as Atypical bacterial pathogens such as Chlamydophila pneumoniae, Mycoplasma pneumoniae, and Legionella pneumophila. In 2019, there were as many as 28.1 million cases of CABP in China. The mortality rate and drug resistance rate have shown high correlation with increasing age of the patients. The unmet medical needs are expected to continue to rise with aging population globally. 

About Everest Medicines

Everest Medicines is a bio pharmaceuticals 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. 

About Xerava™ (eravacycline)

Xerava™ (eravacycline) 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. Everest Medicines received approval of Xerava™ in Singapore for cIAI in April 2020 and the medicine is currently under review for cIAI in 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.