Indian drugmakers need to stay engaged in research and development efforts focused on antibacterial and anti-fungal medicines and align these investments with critical public health needs, said a representative of the Netherlands-based Access to Medicine Foundation (ATMF) .
In fact, they can develop early access programmes to these drugs and design inclusive strategies focused especially on low- and middle-income (LMICs) who have a high disease burden , said Marijn Verhoef, ATMF Director of Operations and Research.
The role Indian drug companies can play in improving access, comes against the backdrop of ATMF’s latest report revealing that global drug companies were falling “dangerously short” on developing replacement antibiotics to tackle anti-microbial resistance (AMR) – a situation that gives rise to superbugs ( bacteria/fungi etc that do not respond to medicines).
In fact, even the handful of antimicrobial projects targeting severe drug-resistant pathogens that are being developed have registrations limited to few developing countries including India, the report said, urging companies to act, so “at least 160,000 people can be saved annually.” While global companies had diverse strategies for access, structured advance planning had not yet become standard, the report from the non-profit organization said.
Responding to queries from businessline, Verhoef called for early access programmes for patients with no or limited treatment options to access antibiotics and antifungals that are not registered yet. The ATMF report mentions Wockhardt’s early access programme to a late-stage antibiotic that helped cure a lady from Nepal, from an “otherwise untreatable infection”.
Verhoef urged companies to file registrations in LMICs, and include countries with “particularly high burdens of disease and disproportionately affected populations, such as children, women and immuno-suppressed patients.”
Just five
The report points out that of the 113 LMICs being analysed, “concrete commitments for registration were only identified in 5 – China, India, Mexico, South Africa, and Thailand. “ Many of the remaining 108 LMICs face high burdens of diseases targeted by the projects and would benefit from access to them, it said.
Generic drugmakers could enable the production of more generic versions of off-patent antibiotics and antifungals by participating in licensing opportunities when originator companies offer the opportunity, Verhoef said. “Support access and stewardship planning by SMEs (Small and Medium Enterprise) either through licensing deals, co-development partnerships or acquisitions,” he added.
Small arsenal
“We have a small, but effective, arsenal in the race to combat drug resistance. The difference between us winning or losing this race depends on how companies enable access to people living on the frontlines of drug resistance,” said Jayasree K. Iyer, ATMF Chief Executive.
The report said that the vast majority of large research-based pharmaceutical companies are no longer active in antimicrobial R&D due to a lack of commercial viability. As a result, very few new treatments make it to market, leaving patients vulnerable to AMR.
The projects in late-stage clinical development analysed by the report included those from GSK, F2G, Innoviva and Venatorx (gepotidacin , olorofim, zoliflodacin and cefepime-taniborbactam, respectively), besides Pfizer’s recently approved aztreonam-avibactam (Emblaveo). These products could treat drug-resistant gonorrhoea, urinary tract infections, intra-abdominal infections, respiratory infections and invasive fungal infections, the report said.
ATMF is funded by the Dutch and UK governments, the Bill and Melinda Foundation, the Leona M. and Harry B. Helmsley Charitable Trust, Wellcome Trust, AXA Investment Managers and Stewart Investors.