Japanese pharmaceutical company Shionogi & Co. has entered into an exclusive licensing agreement with Link Medical Products, part of Clinigen, the global specialty pharmaceutical services group, for the development and commercialisation of cefiderocol in Australia and New Zealand.
The Therapeutic Goods Administration (TGA) regulatory authority in Australia accepted the market authorisation application for cefiderocol and the application is under evaluation.
Under the terms of the agreement, Link will in-license cefiderocol from Shionogi and obtain exclusive rights for its development and commercialization in Australia and New Zealand. Shionogi will receive an upfront payment, milestone payments based on development progress, and royalties from Link.
In Europe, cefiderocol is commercially available under the brand name Fetcroja for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. In the US, cefiderocol is available under the brand name Fetroja and is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia (HABP/VABP) and complicated urinary tract infections (cUTIs) caused by certain susceptible Gram-negative microorganisms.
In Japan, cefiderocol is commercially available under the brand name Fetroja and received manufacturing and marketing approval from the Ministry of Health, Labour and Welfare for various infections caused by strains resistant to carbapenem antibiotics among sensitive strains of Escherichia coli, Citrobacter species, Klebsiella pneumoniae, Enterobacter species, Serratia marcescens, Proteus species, Morganella morganii, Pseudomonas aeruginosa, Burkholderia species, Stenotrophomonas maltophilia, and Acinetobacter species.
