2021-03-30/Operation
TAIPEI, Taiwan, March 30th, 2021－TaiGen Biotechnology Company, Limited (“TaiGen”) announced today that they have signed a transfer agreement for Taigexyn® (Nemonoxacin), a novel broad-spectrum antibiotic, with Zhejiang Medicine Company, Limited (“ZMC”) in China. The agreement, worth upwards of USD 45~50 million, will become effective after approved by the regulatory authorities of both mainland China and Taiwan, and by the shareholders meeting of ZMC.
Under the terms of the agreement, in exchange for ZMC payments to TaiGen in 2021 and 2022 totaling up to USD 45~50 million, TaiGen will transfer China rights of Nemonoxacin to ZMC. As per the agreement, ZMC will make payments according to the achievement of various milestones such as completion of patent ownership transfer, Marketing Authorization Holder (MAH) approval for IV formulation to ZMC as well as the approval of any patent life extensions.
This agreement was being given careful consideration and in response to the implementation of Measures for the Administration of Drug Registration and Measures for the Supervision and Administration of Drug Production in 2020 thereby it was clear that only either TaiGen or ZMC could be nominated as the MAH in any joint application.
After a thorough risk/benefit analysis, especially considering the cost of quality management and drug safety monitoring of manufacturing, distribution, sales, and patient use, TaiGen and ZMC entered into discussions and decided that ZMC will serve as the MAH of Nemonoxacin and be responsible for the manufacturing, quality control, sales and safety monitoring of Nemonoxacin in the territories of China, Hong Kong and Macao.
Facing the threat of pricing pressures for first-line quinolone antibiotics due to patent cliff and entry of generics, TaiGen has shifted focus to target second-line therapeutics of significantly higher value. Towards this end, TaiGen has recently discovered a novel and broad-spectrum antibiotic candidate that satisfies its profile and will be an anchor of TaiGen’s drug discovery pipeline. In vitro antimicrobial susceptibility tests have demonstrated this candidate to be potent and highly effective against numerous wild type and drug resistant Gram-positive as well as Gram-negative bacteria. The candidate is expected to be suitable to address moderate to severe pneumonia, nosocomial infection and infections caused by ventilator, intubation in the hospital setting.