Orchid Pharma, a subsidiary of India’s Dhanuka Labs, has gained a sublicense to manufacture the antibiotic cefiderocol as part of an effort to expand access worldwide.
Cefiderocol is used to treat certain Gram-negative bacterial infections that may be resistant to other antibiotics. The drug was approved by the FDA in 2019 and the European Medicines Agency in 2020, and it's listed on the World Health Organization’s (WHO) Model List of Essential Medicines.
Collaborating in this access effort are the the Global Antibiotic Research and Development Partnership and the Clinton Health Access Initiative, according to a Tuesday release.
The groups, which launched their effort in 2022, are focused on providing the antibiotic to low- and middle-income countries.
“Our decades-long expertise in cephalosporins will be advantageous in manufacturing affordable and quality-assured cefiderocol,” Manish Dhanuka, managing director of Orchid Pharma, said in the release. “This will address the unmet needs of patients across low- and middle-income countries where antimicrobial resistance is spreading.”
As part of the agreement, Orchid must submit the product to the WHO medicines pre-qualification program. Products listed with the program are eligible for a collaborative procedure for accelerated registration, reducing the time for national regulatory approvals to 90 days in participating countries.
At least 1.27 million deaths were attributed to antimicrobial resistance (AMR) in 2019, according to a paper published in The Lancet. The WHO estimates that if no action is taken, more than 10 million lives a year could be at risk of AMR by 2050.
GSK collaborated with Shionogi on the development of cefiderocol, according to Shionogi. The British pharma giant is foregoing its royalties from sales on the medicine in low- and middle-income countries, Shionogi added.