Shionogi shows how a biotech firm can tackle AMR

Policymakers and public health leaders have been playing a dangerous game when it comes to how they are preparing, or rather are not preparing, for the looming bacterial pandemic. Recognizing the urgency of antimicrobial resistance (AMR), biotech firms have been stepping in to take the lead.

“Antimicrobial resistance really is a silent pandemic,” said Gareth Morgan, the Head of Global Portfolio Management and AMR Policy at Shionogi Inc. “It is responsible for nearly 1.3 million deaths globally; more than HIV/AIDS or malaria. It is a big number. If you talk about HIV or malaria, people, of course, perk up and talk about the need for action. That same level of activation really needs to be seen when it comes to addressing AMR.”

Industry leaders have been ringing the alarm for some time now. For example, Michael Dudley of Qpex Biopharma discussed the lack of AMR investment during the BIO International Convention in June 2022, saying, “Over the last 10 years, [in the US,] there was $26 billion put into oncology. But in AMR over the last 10 years there’s only been a $1.6 billion investment.”

Yet, investment in AMR R&D is declining, not increasing. “Right now, our system rewards volume, not value,” according to Sen. Michael Bennet (D-CO), who calls for a pandemic-style “strategic partnership between biotech and the federal government.” Bennet is a co-sponsor of The PASTEUR Act, which would enable public-private partnerships to combat the threat of new AMR infections.

Unfortunately, such legislation is all too rare and is still only a proposal. Until policy gets rolling, companies have had to find creative and innovative solutions to solve the problem of producing and distributing new AMR drugs.

Reaching more patients together

When it comes to those on the frontlines of the fight against AMR, you are more likely to see small to mid-sized biotech companies taking the reins and working to address this pressing public health emergency. Companies like Shionogi, headquartered in Japan, are a perfect example. Shionogi’s July 13 collaboration agreement with the Global Antibiotic Research and Development Partnership (GARDP) and the Clinton Health Access Initiative (CHAI) exemplifies how serious they are about their mission. This collaboration aims to accelerate access to Shionogi’s innovative new antibiotic cefiderocol in low- and middle-income countries.

The collaboration agreement would “significantly transform the landscape of access to antibiotics for countries around the world,” according to their press release. “Under this agreement, GARDP will manufacture and commercialize cefiderocol through sub-licensees in a large range of countries that have delayed access (if any) to newer antibiotics.”

The agreement will provide and expand “access to cefiderocol, an antibiotic for the treatment of serious Gram-negative bacterial infections, which may be resistant to other antibiotic treatments,” the release said.

“Making effective medicines available on a global scale is a big challenge for a mid-size pharma company like Shionogi,” explained Morgan, “We knew that we needed to partner with other organizations to expand manufacturing and distribution in order to get cefiderocol to the global market that needs it. That is where GARDP and CHAI come in as synergistic partners to address the issue.”

“Too often, antibiotic resistance is presented as a problem for the future,” said Manica Balasegaram, Executive Director of GARDP. “In fact, resistant bacterial infections are already costing lives and taking a heavy toll on health systems around the world. We can change that by supporting accelerated access to antibiotics in regions with the highest burden of resistance—that is, where antibiotic access is often neglected and should be prioritized. Thanks to essential support from our funding partners, and in collaboration with Shionogi and CHAI, GARDP is accelerating global access now, so that doctors and patients who urgently need antibiotics can get them. Antibiotic development and delivery go hand-in-hand in GARDP’s efforts to fight antibiotic resistance.”

“Appropriate diagnosis and treatment of bacterial infections, which would include access to innovative medications like cefiderocol, can improve the treatment of life-threatening infections,” said David Ripin, Chief Science Officer and Executive Vice President of Infectious Diseases at CHAI. “CHAI is excited to be a part of this partnership that will ensure that this innovative antibiotic is affordable and available to patients when and where they need it.”

Innovative antibiotic

Ultimately, this new collaboration would not be possible if it were not for Shionogi’s innovative product: cefiderocol, which is an important treatment option when it comes to combating AMR.

“Cefiderocol is a novel antibiotic when you look at how it works,” explained Morgan, “Bacteria need iron, it is an essential micronutrient that allows them to grow and replicate. Problematic Gram-negative bacteria actively transport iron across their outer membranes. Cefiderocol binds to iron and when the bacteria transport the iron across their outer membrane, they bring the cefiderocol into the periplasmic space where it binds to penicillin-binding proteins, thereby disrupting cell wall synthesis and killing the bacteria. It is really a novel and unique molecule.”

A commitment to collaboration on AMR

The effort to distribute cefiderocol is typical of Shionogi’s efforts against AMR. “Shionogi has been very active in the AMR space for a good number of years now,” Morgan said. “We signed the Davos Declaration on Antibiotic Resistance in 2016 and were one of the original signatories on the industry roadmap, which outlined how the industry would work to address AMR. We’re also a founding member of the AMR Industry Alliance, which brings together biotech, diagnostics, generics, and research-based pharmaceutical companies to address AMR. And we’re also a founding member of the AMR Action Fund, the world’s largest public-private partnership, which is working to drive a billion dollars of funding toward the development of new AMR therapeutics. That is all to say that AMR is not something we take lightly; this is an area that we have worked very diligently in for a long time.”

The firm’s collaboration is not only landmark for its scope—aiming to expand education and access to an innovative new antibiotic—it is also innovative in its ability to work across the private and public non-profit sectors to combat AMR on a global scale.

The collaboration is based on Shionogi’s comprehensive and sustainable six-point list for real and concerted action in addressing AMR:

  • Create a predictable and sustainable market for AMR products through economic incentives, such as pull incentives and new value assessments for reimbursement.
  • Harmonize global regulations for the development and approval of new antibiotics.
  • Establish clinical trial networks to help execute clinical studies more efficiently.
  • Ensure appropriate use of antibiotics through regulation of animal use, stewardship, and timely surveillance of resistance epidemiology.
  • Make effective medicines available for patients in need directly or via alliance partners.
  • Reduce environmental impact from the manufacture of antibiotics.

With so much disheartening news about AMR, it is exciting to see companies leading the way towards a safer and healthier future through technology, collaboration, and problem-solving. It gives us all hope that we may one day reach a future without the threat of an AMR pandemic looming overhead.

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