(London, SciDev.Net) Antibiotic production from major pharmaceutical companies has slowed significantly over the past five years, according to new analysis, with children in low- and middle-income countries particularly exposed to hard-to-treat infections.
The report by the Access to Medicine Foundation comes amid a growing global crisis of antimicrobial resistance (AMR), where drugs used to treat serious infections are no longer effective. Previous research shows that AMR contributes to more than four million deaths each year and this number is expected to increase to more than eight million by 2050.
Despite this growing threat, the number of candidate antimicrobial drugs in the pipeline of major research-based pharmaceutical companies has shrunk by 35 percent by 2021, 2026 Antimicrobial Resistance Benchmark The report published on Tuesday (March 10).
Chronic underinvestment, weak development pipelines and a lack of private sector interest mean communities affected by drug-resistant infections suffer.
John-Arne Rottingen, CEO, Wellcome
The report highlights the acute shortage of antibiotics specifically formulated for children. Only 14 percent of the drugs under development by the companies evaluated are for under-fives. In sub-Saharan Africa, no antibiotics are available for children from these agencies in 17 countries.
“Prolonged underinvestment, weak development pipelines and reduced private sector interest mean communities affected by drug-resistant infections suffer,” said John-Arn Rottingen, chief executive officer of the charity Foundation Wellcome, which co-funds the Access to Medicine Foundation’s AMR programme.
Although big pharma companies like GSK are set to bring a few new drugs to market in the coming years, their accessibility and affordability in low-income areas may not be far-reaching, the report suggests.
Seven drugs in late-stage development show promise for treating infections that have shown resistance to other existing antibiotics—from gonorrhea to urinary tract infections (UTIs), according to the benchmark report, which looked at 25 companies.
UK-based pharma giant GSK is involved in three of them, including the already approved UTI antibiotic gepotidacin, while the other drugs will come from smaller companies such as Venatorx and Inoviva.
All companies involved in the development of new antimicrobials have plans to register their drugs, implement early access programs and ensure that patients involved in clinical trials can access the drugs after the research ends, the report said.
But only two of these seven upcoming antimicrobials, from Inoviva and Osuka, are expected to be affordable in low- and middle-income countries, according to an analysis by the Access to Medicine Foundation. The foundation looked at how low- and middle-income countries address the availability, affordability and continued supply of medicines.
“With these treatments so close to reaching the market, current gaps in access planning could leave millions of LMICs with delayed treatment – or no access at all,” the report said.
Encouraging innovation
Martijn van Gerven, research program manager of the AMR program at the Access to Medicine Foundation, said SciDev.Net Companies that do need to have external incentives to make their medicines widely available, such as governments promoting research and development or revenue guarantee schemes, as implemented in the UK. Antibiotics are expensive to manufacture and are not constantly used, making them an attractive investment for many companies, van Garven explained.
The subscription model works when the government subscribes to drugs, to ensure they are available regardless of market dynamics. But it needs to be done globally to be successful, Wellcome’s Rottingen said at a press briefing in London on Tuesday.
While most of the companies analyzed in the report have plans to make their products accessible, the problem is a lack of specificity in those plans, Access to Medicine Foundation research director Claudia Martinez said at the briefing.
“What we want to see is not a huge gap between registration and availability,” he said.
Most antibiotics sold around the world come from generic manufacturers—companies that make off-patent, cheaper drugs. They are mostly sold in low and middle income countries.
The benchmark report analyzed ten generic manufacturers, including Abbott, Hikma and Sandoz, and found that six of them tracked how many patients their products reach in low- and middle-income countries. Sandoz and Viatris were the only companies that did this type of tracking for all their drugs. According to reports, Fresnias Kabi and Alchem do not disclose details of their patient tracking methods.
Local production
For Ayodele Majekodunmi, a Nigeria-based One Health epidemiologist and executive director of data company Azisefini Consulting, the real game-changer in reaching low- and middle-income countries is ensuring that at least part of the production takes place in those countries, so that costs fall.
This can be done when big pharma companies partner and transfer knowledge to other companies in the Global South, or when those big players set up factories in low-income areas, explains Majekodunmi, who heads the World Organization for Animal Health’s Health Security Programme, West and Central Africa project. But the former leaves countries less vulnerable to big pharma companies that may decide to leave a particular market, he added.
“Where you have local companies that are owned by people from that country, there is nowhere for you to pack up and go. So local ownership and local investment is a must,” says Majekodunmi. SciDev.net.
Affordable access
says Anand Anandakumar, founder of India-based biopharmaceutical company BugWorks SciDev.Net He is implementing a strategy to ensure that his company’s novel antibiotics—which have not yet been tested in humans—reach as many people as possible around the world when they are ready for sale.
According to Anandakumar, Bugworks is working with the Global Antibiotic Research and Development Partnership (known as GARDP) to make its products affordable.
Subject to regulatory approval, Anandakumar hopes to have his antibiotics manufactured in India and help GARDP stockpile them for distribution in Latin America and Africa.
“I think if you guarantee enough volume, manufacturers in India can make a ton of products for most of the developing world,” he said.
GSK Chief Scientific Officer Tony Wood said in a press statement that GSK is using cutting-edge technology to bring much-needed innovation to patients, including a new first-in-class antibiotic last year. “While this is welcome progress, it is not enough and today’s report emphasizes the need for government and industry to work together to improve economic incentives for R&D and implement better access and stewardship models,” the statement said.
This piece was produced by SciDev.Net’s Global Desk.
