Antimicrobial Resistance (AMR) stands as one of the greatest threats to human health and the progress of modern medicine today. According to the World Health Organization (WHO), it ranks among the top 10 global public health threats, pushing healthcare systems towards growing uncertainty. Recent global statistics indicate that between 2020 and 2021, approximately 1.2 million people died annually as a direct result of drug-resistant pathogens, while the indirect death toll reached nearly 4.8 million. Experts warn that without effective preventive measures at both global and national levels, AMR could claim 10 million lives annually by 2050. This means that roughly every three minutes, someone could die from a common infection that cannot be treated with any currently available medication.

The write-up is a part of Without Borders Media Fellowship by MSF-GARDP Grant on Antimicrobial Resistance, which encourages independent, impartial, and neutral reporting on health and humanitarian crises. 

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What is cefiderocol and how does it work?

Cefiderocol is a siderophore cephalosporin antibiotic with an innovative mechanism of action against Gram-negative pathogens. In addition to entering cells by passive diffusion through porin channels, cefiderocol “fools” the bacteria by binding to iron and getting actively transported into bacterial cells via bacterial iron transporters.

Data from multinational surveillance studies demonstrate potent in vitro activity against a wide spectrum of Gram-negative pathogens including carbapenem-resistant A. baumannii, P. aeruginosa and Enterobacterales.

GARDP’s role in accelerating access to cefiderocol.

Working with CHAI and Shionogi, GARDP has entered into a license and technology transfer agreement to support wider access to cefiderocol. This is the first such license agreement for an antibiotic to treat serious bacterial infections between a pharmaceutical company and a non-profit organization. Under this agreement, GARDP has the rights to manufacture and commercialize cefiderocol through sub-licensees in 135 countries that normally face delayed access to newer antibiotics.

GARDP subsequently entered into a sublicense agreement with India-based Orchid Pharma Ltd (Orchid) to manufacture cefiderocol at its plant in Chennai, in India. This agreement has important access, environmental, and stewardship provisions, to help keep the product affordable for patients and health systems in low-resource settings.

The potential impact

The cefiderocol project represents a new model for bridging global access gaps for important antibiotics. Even though populations in LMICs face high mortality from drug-resistant bacterial infections, their access to new antibiotics is usually delayed by more than a decade. This delay has dire consequences given that the number of serious, life-threatening, infections caused by carbapenem-resistant bacteria that require newer antibiotics for optimal treatment, has been steadily growing across multiple regions, including South Asia and Latin America.

By addressing barriers that have historically limited the availability of important antibiotics, this innovative project aims to accelerate appropriate access to an affordable, quality-assured antibiotic for those who need it most.

Where does the project stand?

Until now, cefiderocol has been available in only a few high-income countries. Landmark licensing agreements are changing this, with more countries set to gain access to this important Reserve antibiotic over the coming years.

With GARDP’s support, efforts are underway to establish manufacturing capacity in India through Orchid in order to increase production and create a supply chain for LMICs. GARDP is also working to support sustainable introduction of cefiderocol in specific countries, providing technical support for registrations, stewardship and clinical use.  

Key milestones

Signed

2022 – Shionogi, GARDP and CHAI announced landmark license and collaboration agreements to treat bacterial infections by expanding access to cefiderocol in up to 135 countries.

Signed

2023 – GARDP and Orchid signed a sublicense agreement for manufacturing. It is a critical step in increasing access in LMICs, pending local authorization or national regulatory approval.    

COMPLETed

2024 – GARDP’s sublicensee, Orchid, successfully synthesized cefiderocol API (Active Pharmaceutical Ingredient) at laboratory scale.

Ongoing

2025 to 2027 – Construction of dedicated active pharmaceutical ingredient (API) and drug product facilities for cefiderocol by Orchid.

Resources

Statement

10 February 2026

Statement on Brazil’s draft National Action Plan for Antimicrobial Resistance

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Statement

23 March 2023

GARDP welcomes first-ever WHO list of antibiotics to be prioritized for paediatric development

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Partners

12 September 2023

Critical agreement paves way for new model to accelerate access to important antibiotics for serious bacterial infections

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Agreements

Cefiderocol license and technology transfer agreement

Cefiderocol manufacturing sublicense

Cefiderocol license agreement overview

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What is BWC0977 and how does it work?

BWC0977 is a pyrazino-oxazinone class antibacterial with broad-spectrum activity against both Gram-positive and Gram-negative pathogens. It targets both, DNA gyrase and topoisomerase IV, thus interfering with bacterial DNA replication. Because of the way BWC0977 binds to these DNA replication enzymes it may have lower potential for cross-resistance with known antibiotic classes.

The potential impact

At the time that GARDP and Bugworks signed the agreement for the co-development of BWC0977 IV formulation in May 2024, BWC0977’s first in human trials (phase 1) clinical development was being supported by CARB-X. By providing critical support at this relatively early stage in drug development, GARDP ensures that BWC0977’s development aligns with global public health needs and includes access as a critical component from the get-go. In June 2025 GARDP and Bugworks expanded the agreement to include the co-development of BWC0977 oral formulation.

As part of this, GARDP holds manufacturing and commercialization rights for IV and oral formulations of BWC0977 in 146 countries, almost all of which are low- and middle-income countries (LMICs).

Rights in 146 countries

Where does the project stand today?

The IV formulation is currently undergoing a phase 1 trial. IV formulations are well suited for use in hospital environments where patients with serious, drug-resistant infections require urgent, effective care.

At the same time, preparations for the oral formulation to enter a phase 1 clinical trial are ongoing. This version will offer a much-needed step-down option from IV therapy, especially vital for last-mile settings. It also has the potential, with proper stewardship, to serve as a stand-alone treatment in low-resource settings for patients battling extensively drug-resistant serious bacterial infections. Oral treatments for extensively drug-resistant Gram-negative infections are a global unmet medical need.

Key milestones

Signed

2024 –  GARDP signed the collaboration and license agreement with Bugworks to develop an intravenous form of the investigational compound BWC0977.

SIGNED

2025 – GARDP signed the collaboration agreement with Bugworks to include the oral form of BWC0977.

ONGOING

2024 to present – GARDP is providing technical and financial support to Bugworks for the co-development of BWC0977. GARDP was involved in the development of a new BWC0977 IV formulation currently being tested in the ongoing phase 1 IV trial, and also for a new oral formulation to be used in the upcoming phase 1 oral trial.

Resources

Media Coverage

9 August 2023

Bugworks and GARDP collaborate to accelerate development of novel antibiotic to treat serious infections

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Partners

28 July 2023

GARDP and Bugworks join forces to accelerate development of a novel antibiotic to treat serious bacterial infections

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Press Release

9 June 2022

GARDP supports Bugworks in assessing safety of new antibiotic compound

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Agreements

Bugworks-GARDP collaboration and license agreement overview

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A fifth of blood cultures from patients with infections acquired in a healthcare setting in South Africa will yield an organism. Carbapenem-resistant Enterobacterales (CREs), specifically Klebsiella pneumoniae are the most predominant Gram-negative bacteria (GNB) isolated among bloodstream infections (BSI). Additionally, the multidrug-resistant nature of these organisms is not only a threat to patients but it also poses a big public health challenge to current treatments and highlights the need for the development of new antimicrobials. Therefore, CRE have been placed on the critical priority list by the World Health Organization (WHO). We aimed to provide a holistic overview of the GERMS-SA CRE BSI surveillance data from 01 July 2015–31 December 2021.

Authors

Husna Ismail, Thembekile Buhle Christna Zwane, Elloise Du Toit, Renata Maria Augusto da Costa, François Franceschi, Olga Perovic

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1 May 2025 

Nearly a million people are dying in India each year from drug-resistant infections, many of which go untreated due to lack of access to the right antibiotics. A new study1 lays bare the scale of the problem, revealing that in 2019, just 7.8% of people in India received appropriate treatment for life-threatening carbapenem-resistant Gram-negative (CRGN) bacterial infections.

The study, led by researchers from the Global Antibiotic Research & Development Partnership (GARDP) and academic collaborators, is the first to quantify the treatment gap for antimicrobial-resistant infections in low- and middle-income countries (LMICs). Drawing on mortality data and pharmaceutical sales figures from India and seven other LMICs, the team estimated that there were more than a million CRGN infections in India in 2019, but only 83,468 courses of suitable antibiotics administered.

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“My mother went into hospital well and healthy but died a week after giving birth to my sister,” says Mirfin. “While recovering from a C-section, she picked up an infection which was resistant to the available antibiotics in the hospital. It rapidly led to sepsis. I’ve always believed that my mother’s death could have been avoided if they’d had the right antibiotics to treat her infection.”

The tragedy was a turning point for Mirfin, who was 18 at the time. He decided to study to become a clinical pharmacist. Since his home country of Zambia didn’t have a pharmacy school, he got a scholarship for his undergraduate studies in Tanzania. He later specialized in infectious diseases and public health in the United States before going back to Zambia. Mirfin has since become one of the leading global voices on the importance of accessing effective antibiotics and advocating for ways to prevent antimicrobial resistance.

As the co-founder of ReAct Africa, Mirfin and his team have supported many African governments in developing and implementing their national action plans on antimicrobial resistance.

Mirfin is particularly proud of the growing band of young volunteers he has helped to nurture over the years. Through ReAct Africa, young people, mostly students, are taught about AMR and how to bring about change through using antibiotics appropriately, and how to prevent infections. They in turn take the knowledge they’ve learnt deep into the community – from schools and clinics to churches and campuses, often relaying their message through art, poetry and theatre. Students have also formed One Health clubs. The programme has cascaded into a range of African countries, such as Kenya, Tanzania and Liberia.

Many of these young ‘AMR champions’, together with policymakers, healthcare workers and researchers also gather at the annual AMR conferences in Zambia, hosted by ReAct Africa and the South Centre. The conference pulses with excitement and energy as people talk about what they are doing to improve infection prevention and control, prevent misuse of antibiotics and increase access to effective antibiotics.

They also discuss ways to best engage politicians, intergovernmental organizations and the global community to counter AMR in Africa, which is disproportionately affected by AMR.

Mirfin has put AMR firmly on the African agenda and onto the global stage. He has become a sought-after speaker in global conferences and working groups and often writes on gaps in access to antibiotics and diagnostics, AMR as a health security issue and other vital issues. He has also supported the World Bank and Africa CDC and other organisations in their work in Africa and Asia.

For Mirfin, life has turned full circle. “My mother’s death was devastating. But it inspired me to commit to this field. Antibiotic resistance causes so much illness and death. It drains money from families as people become too ill to work. It also leaves people feeling desperate as they often can’t afford some of the third or fourth generation antibiotics that could work, if they are available at all. People often resign themselves to die,” says Mirfin.

This is an untenable situation, which needs change, and constant attention, especially in Sub-Saharan Africa, which is particularly hard-hit by drug-resistant infections. While more funding and commitment is needed, Mirfin is not giving up the fight.

“We’ve been strong advocates, not just at a country or regional level, but globally. We have worked with intergovernmental organisations and the Africa CDC on stemming AMR. Our young people – as the doctors, nurses and pharmacists of tomorrow – are playing their part. We have been the voice of the Global South, and we want to get even stronger.”

Mirfin’s mother would have been proud. He has honoured her memory through his dedication towards a better outcome for this generation and those to come.

This story was made in collaboration with ReAct Africa. 

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For Bhakti Chavan, this was not a hypothetical question but a reality. At 23 years old and living in Mumbai, India, Bhakti was diagnosed with extensively drug-resistant tuberculosis (XDR TB). TB is caused by Mycobacterium tuberculosis, which like other bacteria as well as viruses, fungi and parasites, can develop defenses over time, rendering antimicrobial medicines less and less effective.

In the case of Bhakti, none of the first- or second-line treatments would work. Instead, she would have to get daily injections of novel antibiotics and take 7-8 combinations of antibiotics as pills over several months. Bhakti suffered from horrible side effects ranging from nausea to blurred vision and depression, and she was nearly completely isolated from her friends.

“It’s physical, financial, social,” she said.

After eight months of intensive treatment, Bhakti stopped receiving injections but continued taking antibiotics in the form of pills. In July 2019, Bhakti finally finished her treatment, nearly two full years after it began.

“In my case, I was very fortunate to get a timely diagnosis and have access to novel medicines provided by Médicins Sans Frontières (MSF). But there are many patients who are misdiagnosed for years, and they don’t get access to those medicines.”

Her experience instilled her with a passion for advocacy and antimicrobial R&D. She now works for a biotech company, where she contributes to the development of novel therapeutics and diagnostics to combat antimicrobial resistance (AMR). Bhakti is also part of the WHO Task Force of AMR Survivors.

“AMR exists – it’s not a future pandemic. Without any prior history, I got infected with drug-resistant TB. If it can happen to me, it can happen to anybody,” says Bhakti.

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Tori Kinamon was a talented 19-year-old college gymnast in the US when she felt a pain in her left hamstring. Her trainer suspected she’d strained it, while an X-ray didn’t detect anything abnormal. The student health department suggested she go home and rest.

But Tori was worried. Within days the pain was excruciating.

“It was so painful that I couldn’t walk. My leg was red and swollen. I had night sweats, a fever and my blood pressure plummeted.”

Tori phoned her mom. Concerned, she took her straight to hospital. “I think she knew something was terribly wrong,” says Tori. Doctors thought she had cellulitis and put her on broad-spectrum antibiotics. Within 24 hours she wasn’t showing any improvement.

Finally, imaging studies showed a large abscess in her hamstring muscle.

“The bacteria were in my bloodstream and then travelled to my hamstring. They set up shop there and multiplied rapidly to the point where I had an 18-centimetre abscess and an associated infection of the hamstring muscle. It was a very deep and severe infection, probably because it was not intervened upon earlier.”

Tori’s road to recovery was tough. It took a month in hospital and several surgeries to drain the wound and clear away the Methicillin-resistant Staphylococcus aureus (MRSA) infection, which is caused by a type of staph bacteria that has become resistant to many of the antibiotics used to treat ordinary staph infections.

Tori credits an effective antibiotic as being key to her eventual recovery.

“I had a great outcome because we had an extra antibiotic in the stockpile to treat my infection. It worked and I was so fortunate. It convinced me that we need to devote a lot of energy, brain power and funding to antibiotic development, especially with the threat of increasing antimicrobial resistance.

“Antibiotics are no longer a luxury that we can take for granted. It is a community, a national and international problem that we all need to be concerned about, because our lives depend on it. Mine certainly did.”

Tori also realised that antibiotics need to be tailored towards patients and their health conditions.

“It’s important to have the right antibiotic, at the right time, for the right patient because each patient responds differently to antibiotics.”

The experience has propelled Tori to do something positive.

“While in hospital, I made a commitment to myself that I was not going to be a victim of this infection. First and foremost, it meant that I was going to devote myself to research; to find out why MRSA happens, and how to prevent it. I also decided to study medicine.

“It expanded my interest in infectious disease and antimicrobial resistance. It allowed me to make meaning from my suffering. On top of that, I vowed to return to college gymnastics.”

From being unable to walk, Tori worked with a physiotherapist to regain muscle strength. Step by step, she got stronger, and returned to college gymnastics within six months…a huge achievement.

Now a qualified doctor, Tori is passionate about spreading the word about MRSA.

“MRSA infections are becoming more prevalent. As an athlete, you’re sharing surfaces; you have cuts and scrapes. Infections can happen to anyone. There is a lot of victim blame. People say: ‘If you’re clean and you shower after practice, you’re not going to get this’. But I was highly hygienic, and it happened to me.”

Tori believes reducing stigma around bacterial infections and increasing awareness and education amongst healthcare providers and patients is critical.

She has designed a curriculum to educate other college athletes about the warning signs of an MRSA infection.

“It’s important to know that if you have pain out of proportion to your injury, a red, swollen limb or joint, and you don’t feel well, trust yourself, trust your body and seek care,” she suggests.

“I’ve been on all sides of the AMR issue – as a patient, student, researcher and scientist. Ultimately, we’re all susceptible to AMR. It affects us all.”

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