Everest Medicines (HKG: 1952) announced that its New Drug Application (NDA) for Xerava (eravacycline) for the treatment of complicated intra – abdominal infections (cIAI) has been accepted for review by the Taiwan Food and Drug Administration (TFDA).
Partnership Details
The China-based biopharma also entered into an exclusive partnership agreement with TTY Biopharm for the commercialization of Xerava in Taiwan. Under the 10-year partnership, which may be extended, TTY will be responsible for all commercial activities related to Xerava in Taiwan. TTY Biopharm, one of Taiwan’s largest local pharmaceutical companies, has a track record of successfully commercializing novel anti – infective products in the region, including Brosym (cefoperazone + sulbactam), Colistin (colimycin), and Cubicin (daptomycin).
Drug Background
Xerava (eravacycline) is a novel, fully synthetic, broad – spectrum, fluorocycline, parenteral antibiotic of the tetracycline class. It has demonstrated 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 cIAI in the US, EU, UK, and Singapore. The drug is under review for cIAI in Greater China and is also being developed for community – acquired bacterial pneumonia (CABP). Xerava was licensed from Tetraphase Pharmaceuticals, a subsidiary of La Jolla Pharmaceutical Company.-Fineline Info & Tech
