Merck, Novo Holdings and several smaller drug developers are partnering with the Biotechnology Innovation Organization (BIO) trade group in a new initiative to spur research and development in the fight against superbugs.
The “Working to Fight AMR” awareness and lobbying campaign tackles the problem of drug development in antimicrobial-resistant drugs, as most big companies have already moved out of the low-margin business. Executives from Novo Holdings, Merck, Entasis Therapeutics, Evotec, Paratek Pharmaceuticals and Forge Therapeutics are lending expertise to the group, said Greg Frank, BIO’s director of infectious disease policy, who is heading up the coalition. He expects the companies to not only contribute ideas, but also provide real-world stories about what they’re doing and why they need help in the antimicrobial battle.
The first action for the new initiative is to draw attention to legislation called the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act. The bill, introduced in both the House of Representatives and the U.S. Senate, would allow larger reimbursements for qualifying new antibiotics, which are mostly used in hospitals. DISARM would also require record-keeping and a stewardship program for those hospitals to make sure the act wouldn’t create an opposite incentive to use the drugs more often, Frank said.
The "Working to Fight AMR" website features a location-enabled call-to-action box that allows viewers to email a letter or create a video to send to their Congressional representatives.
Drugmakers have backed off superbug fighters in part because they’re expensive and offer minimal returns on investment. That’s resulted in a dearth of pipeline drugs. The World Health Organization estimates worldwide death totals of around 700,000 annually now will increase to 10 million people per year by 2050. Urgency is key, Frank said
“If we have additional failures in the antimicrobial space, the ripple effect on what’s left of the pipeline will be quite dire. Everything we do now could take 10-15 years to be developed and actually make it to the market. It’s important not to spend any more time in inaction,” he said.
The failure he’s referring to is the bankruptcy of small biotech Achaogen earlier this year. It had received FDA approval for Zemdri to treat complicated urinary tract infections, but it was later rejected for an additional indication in bloodstream infections.
The new coalition isn’t the only group sounding the alarm on antimicrobial resistance. WHO, the Centers for Disease Control and many governments around the world have called out the problem and warned that time is of the essence for viable solutions.