In global access push, Orchid Pharma picks up license to manufacture antibiotic from GSK and Shionogi
12 Sep 2023
License out/inDrug Approval
Preview
Source: FiercePharma
India's Orchid Pharma has gained a sublicense agreement to manufacture GSK and Shionogi's cefiderocol as part of a global effort to expand antibiotic access worldwide.
Orchid Pharma, a subsidiary of India’s Dhanuka Labs, has gained a sublicense to manufacture the antibiotic cefiderocol from GSK and Shionogi 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.
Also collaborating in the access effort are the the Global Antibiotic Research and Development Partnership and the Clinton Health Access Initiative, according to Shionogi's 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, the Japanese drugmaker said. The British pharma giant is foregoing its royalties from sales on the medicine in low- and middle-income countries, Shionogi added.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
-Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.