Image credit: Xerava.com
China's Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, has announced that the Taiwan Food and Drug Administration (TFDA) has accepted the submission of a New Drug Application (NDA) for Xerava (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI).
In addition, the company has entered into an exclusive partnership agreement with TTY Biopharm for commercialization of Xerava in Taiwan. Under the partnership, which includes a 10-year term upon the launch of Xerava in Taiwan with possibility of extension, TTY will be responsible for all commercialization of the product in Taiwan.
Everest Medicines has exclusive rights to develop and commercialize Xerava in Greater China, South Korea, and the key markets of South East Asia, under a licensing agreement with Tetraphase Pharmaceuticals (a wholly owned subsidiary of La Jolla Pharmaceutical Company). Xerava was approved for the treatment of cIAI in adults in Singapore in April 2020 and is currently under regulatory review for cIAI in mainland China and the Hong Kong region.
