W.H.O. Warns That Pipeline for New Antibiotics Is Running Dry


With the pipeline for new antibiotics slowing to a trickle and bankruptcies driving pharmaceutical companies from the field, the World Health Organization on Friday issued a fresh warning about the global threat of drug resistant infections.

Some 700,000 people die each year because medicines that once cured their conditions are no long effective. Yet the vast majority of the 60 new antimicrobial products in development worldwide are variations on existing therapies, and only a handful target the most dangerous drug-resistant infections, the agency said in a report.

“We urgently need research and development,” said Sarah Paulin, technical officer of Antimicrobial Resistance and Innovation at the W.H.O. and an author of two reports on the subject issued Friday. “We still have a window of opportunity but we need to ensure there is investment now so we don’t run out of options for future generations.”

Without government intervention, the United Nations estimates that resistant infections could kill 10 million people annually by 2050 and prompt an economic slowdown to rival the global financial crisis of 2008.

[Read our series on drug resistance, Deadly Germs, Lost Cures.]

In the two reports — one that analyzed products being tested on patients and another that looked at therapies in the early stages of development — the W.H.O. cited the grim economic realities that have been shutting down investment in the field by major pharmaceutical companies and strangling the few remaining small companies that have come to dominate development of antimicrobial therapies.

Unlike drugs that treat chronic conditions and are taken for years, antibiotics save lives, but are taken for just a week or two, diminishing their profitability for drugmakers.

The sense of crisis has mounted in recent months as a number of American drug companies with promising new products have gone belly up. Among them are Melinta Therapeutics, which declared bankruptcy three weeks ago after failing to turn a profit on the four antibiotics it has on the market. Two other antibiotic start-ups, Achaogen and Aradigm, also went out of business last year.

Drug company executives, public health experts and advocates for patients — groups often at odds with one another — have been united in urging Washington to enact new policies and programs that would help shore up the finances of ailing antibiotic companies and lure pharmaceutical giants back to the field.

“Without such incentives, I’m worried these innovative companies developing new medicines will struggle to obtain the resources they need to fully develop them and bring these breakthroughs to patients,” said Greg Frank, director of Working to Fight AMR, an advocacy group funded by the pharmaceutical industry.

The outlook isn’t entirely grim. In its report on potential innovative therapies, the W.H.O. identified 252 agents in development that target 12 pathogens the health agency has declared grave threats to humanity. They include multidrug-resistant E. coli, salmonella and the bacteria that cause gonorrhea.

Nearly 80 percent of these products are being developed by drug companies, the vast majority of them in Europe and North America, and they include a number of novel therapies like phages and antimicrobial peptides that offer the possibility of treating infections without a reliance on traditional antibiotics.

“It is very encouraging to see a wide variety of new innovative approaches in the preclinical pipeline,” the study said. “Nonetheless, many scientific challenges are yet to be overcome.”

The report on drugs in the later stages of development was less sanguine. Only eight new antibiotics have been approved since 2017, it said, and most are derivatives of existing drugs. The majority of them do not treat pathogens on the W.H.O.’s list of urgent threats.

Of the 50 new antibiotics being tested in clinical trials, only two are active against the most worrisome class of bugs, called gram negative bacteria, that can prove deadly for newborns, cancer patients and those undergoing elective procedures like hip and knee replacements.

It can take ten years and cost more than $2 billion to develop a new antibiotic and bring it to market, and much of that expense is for the failures along the way. Congress has been considering a bill that would shore up the market for antibiotics but it has yet to advance, despite bipartisan support.

In the meantime, many experts worry that the few remaining start-ups in the field may not survive.

“We can’t have more companies going bankrupt,” said Dr. Helen Boucher, an infectious disease specialist at Tufts Medical Center and a member of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. “If the pipeline remains this anemic, that’s going to have real implications for our patients.”


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