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Smaller companies at the heart of innovation on new antibiotics can boost their chances of getting promising drugs to market by forging close links with partners in developing countries.
This is one of the messages in a report by non-profit organisation the Access to Medicine Foundation that highlights how small and medium-sized enterprises (SMEs) developing antibiotics face a fight to avoid bankruptcy.
The world has grown increasingly reliant on such SMEs following the departure of many large companies from antibiotic development, the report says, with new antibiotics and antifungals desperately needed amid rising resistance.
“If the loss of such promising products continues, the pandemic of drug-resistant infections will pose a bigger global health emergency than COVID-19.”
Access to Medicine Foundation
Antimicrobial resistance occurs when organisms such as bacteria and parasites adapt and stop responding to medicines, which makes infections more difficult to treat.
The report notes that 5.7 million people die yearly from lack of access to the right antibiotics, mainly in low- and middle-income countries (LMICs), and 700,000 from drug-resistant infections. It says 55 antibiotics are currently in late-stage development.
“When SMEs fail, their pipelines are frozen, leaving new drugs stranded on the lab bench,” the report warns. “If the loss of such promising products continues, the pandemic of drug-resistant infections will pose a bigger global health emergency than COVID-19.”
Fatema Rafiqi, a research programme manager in antimicrobial resistance at the Access to Medicine Foundation said: “SMEs are the key innovators in the arena. Seventy-five per cent of the late-stage pipeline is associated with those enterprises.”
While fresh incentives and innovative subscription-based models for drugs are needed, says the foundation, smaller drug makers can take steps in the meantime to minimise risks and unlock new funds.
Partnerships with hospitals, organisations and manufacturers in LMICs could accelerate drug development and access to local resources and expertise in places that urgently need the drugs, analysts say. And such link-ups could help save SMEs from the “valley of death”, where early research funding dries up prior to financial returns.
Although it is a “fragile” market, various players are moving in the right direction, says Rafiqi. The report cites several US-headquartered antibiotics developers that it says follow a partnership approach in countries like India and South Africa, as well as China. This enables clinical trials with a higher number of relevant participants in places with some of the highest AMR rates.
“Those partnerships can then lead to partnerships with local generic manufacturers, and manufacturing and distribution centres. That can facilitate quicker access,” said Rafiqi. It can also be a springboard to doing the same in other countries, she added.
Biotech Bugworks, for example, has partnerships in India and South Africa, with the potential of expanding accessibility to other countries in South-East Asia and Africa if products can be successfully moved through the pipeline.
The report notes that India offers good potential for partnerships, given its own investment in its domestic pharmaceutical industry.
Jehangir Cama, an industry research fellow working on antimicrobial research and development at the University of Exeter, UK, said: “The report importantly stresses the need for equitable access to both old and new drugs.” With the world in discussions over how to enable access to COVID-19 vaccines, it needs to be highlighted more for antimicrobials, he says.
“Working with LMICs will be particularly helpful for matters such as patient recruitment for clinical trials,” added Cama. “LMICs have a high burden of resistant infections, and these are exactly the areas that will likely need new antimicrobials first.”
Parallels have already been seen in the way that the Serum Institute of India was authorised to supply COVID-19 vaccines developed by Oxford-AstraZeneca, he points out.
Seamus O’Brien is director of research and development at the not-for-profit Global Antibiotic Research and Development Partnership (GARDP), a reviewer on the report. He says partnerships are promising, though link-ups can be a challenge because SMEs may lack resources or local knowledge.
Drug development, O’Brien believes, must also be backed by appropriate incentives, and supported by governments and the global health and development sectors. “It is of utmost importance that companies exploring partnerships with low- and middle-income countries are further supported through pull initiatives and reimbursement schemes to ensure new antibiotics are not stalled in their development and commercialisation,” he said.