Shionogi quests to slay antibiotic resistance with cefiderocol licensing and collaboration troika

Shionogi is teaming up with the Global Antibiotic Research and Development Partnership (GARDP) and the Clinton Health Access Initiative (CHAI) in a bid to boost antibiotic access worldwide. 

The troika hinges on the antibiotic cefiderocol, which is used to treat serious Gram-negative bacterial infections that may be resistant to other antibiotics, the partners explained in a release. Approved by the U.S. FDA in 2019 and the European Medicines Agency in 2020, cefiderocol recently found its way onto the World Health Organization’s (WHO’s) Model List of Essential Medicines, too.

Antimicrobial resistance is a mounting problem around the globe, and it’s expected to contribute to 700,000 deaths each year worldwide, WHO points out on its cefiderocol fact page. “If action is not taken, it is estimated that 10 million lives a year will be at risk from drug-resistant infections by 2050,” the organization warns.

Meanwhile, the problem could be even worse than expected, Shionogi, GARDP and CHAI argued, citing a recent study that found antibiotic resistance caused nearly 1.3 million deaths worldwide in 2019, almost double previous estimates.

Working with Shionogi, Swiss not-for-profit organization GARDP will produce and sell cefiderocol through sub-licensees in a “large range of countries that have delayed access (if any) to newer antibiotics,” the partners said. The license is expected to cover “all low-income countries, most lower middle- and upper middle-income countries,” as well as “select” high income countries. That’s 135 countries altogether, or about 75% of countries worldwide, the partners pointed out.

The license territory “includes a significant proportion of the world’s population living in areas most affected by antibiotic resistance,” the triumvirate added.

Getting the antibiotic to patients will require the partners to surmount several “technical, legal, regulatory and economic barriers,” which is where the Clinton Health Access Initiative comes in. CHAI, for its part, is well versed in working with the public and private sectors to “reshape markets and introduce medicines in countries around the world,” the partners added.

As for how that will look in practice, pricing models and distribution frameworks still need to be hammered out, Jennifer Cohn, global access project leader at GARDP, told Stat News.

Under the collaboration, Shionogi, GARDP and CHAI will coordinate with health ministries and other experts in a bid to bolster “hospital-based stewardship programs that ensure appropriate use,” which is especially important on the quest to avoid fueling resistance to cefiderocol.

The license deal marks the “first” for an antibiotic to treat serious bacterial infections “between a pharmaceutical company and a non-profit organization driven by public health priorities,” Shionogi said. What’s more, the project has a “broader purpose” insofar as it could “pave the way for antibiotic access more generally.”

Shionogi and GARDP will publish their license agreement in hopes that it could serve as a “baseline” for similar agreements moving forward.

Elsewhere, the U.K. could soon roll out a new Netflix-adjacent subscription-like model for Shionogi’s cefiderocol and Pfizer’s ceftazidime/avibactam, also known as Zavicefta, Pharmaphorum reports.

The country’s Department of Health, NHS England and NICE have wrapped up an evaluation of the two antibiotics, which the NHS in England would pay to access for a fixed annual fee of 10 million pounds sterling, calculated based on the value the meds present to the health service regardless of how much is used to treat patients, the news outlet explains.

The proposed contracts are still in the draft stages and would last for 10 years. They’re expected to be finalized in the coming weeks. Pfizer and Shionogi presented their drugs for consideration in the framework when it was unveiled back in 2019, Pharmaphorum added.