Shionogi to provide global access to its antibiotics, with focus on poor countries, as resistance fears grow
As the world faces a growing challenge of pathogens resistant to antibiotics, Shionogi and the GARDP have committed to an execution of a license and technology transfer agreement with the Clinton Health Access Initiative (CHAI).
According to Shionogi, the collaboration agreement will aim to increase access to antibiotics for countries around the world, with an emphasis on lower- and middle-income nations. The agreement will focus on cefiderocol, an antibiotic for the treatment of serious Gram-negative bacterial infections.
Despite bumps in the road in getting the drug off the ground, cefiderocol was eventually added to the WHO’s model list of essential medicines and does target several Gram-negative WHO priority pathogens. The drug was eventually approved by the FDA in 2019 and by the EMA in 2020.
“Shionogi is committed to ensuring that cefiderocol is accessible worldwide as a potential treatment option for certain highly resistant Gram-negative infections,” said Takuko Sawada, SVP of the integrated disease care division at Shionogi, in a statement.
According to Shionogi, the agreement will see GARDP manufacture and commercialize cefiderocol through sub-licensees to around 135 countries that have delayed access to newer antibiotics. The license includes all low-income countries, lower middle- and upper middle-income countries, and select high-income countries. The deal also includes a significant proportion of the world’s population living in areas most affected by antibiotic resistance.
Financial details of the deal were not disclosed.
The agreement also includes provisions to work with ministries of health and other experts to strengthen hospital-based stewardship programs that ensure appropriate use. These provisions are especially important to avoid fueling resistance to cefiderocol.
While the drug is now approved, it did go through quite a ride to get the greenlight. In 2019, investigators provided positive data for the drug to treat cases of complex urinary tract infections, but an FDA review flagged an imbalance of deaths between the antibiotic and a control arm — with a “higher mortality in cefiderocol-treated patients was observed in a trial in critically ill patients with a variety of infections due to carbapenem-resistant organisms.”
Shionogi itself is fresh off a deal partnering with F2G, a self-described “rare fungal disease company,” to push F2G’s olorofim through clinical trials and regulatory action in Europe and Asia. Shionogi paid F2G $100 million upfront, followed by up to $380 million in downstream milestones and double-digit royalties on potential sales.
Despite all the partnerships and deals, Shionogi $SGIOF is still feeling the bite of the bear market as the company sees its stock down 30% since the beginning of the year.