The creation of the AMR Action Fund came at a very curious time, just months after the world was overwhelmed with the coronavirus pandemic.
Backed by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the AMR Action Fund said in July it had raised nearly $1 billion to develop new antibiotics to combat the well-known problem of antimicrobial resistance (AMR). Pfizer pledged $100 million, Boehringer Ingelheim $50 million, with the European Investment Bank and the World Health Organization (WHO) providing support as well.
Aside from the scare of the coronavirus pandemic, why the urgency? Most large drug companies, including many who are funding the AMR Action Fund, previously abandoned development of antibiotics. Smaller companies have attempted to fill the void, along with government incentives such as the QIPD (Qualified Infectious Disease Product) designation.
It appears, however, stepping up to the science was not enough. After gaining approval for new antibiotics to address AMR problems, two companies – Achaogen and Melinta – failed to survive as public companies after launching their new drugs. A third, Tetraphase filed for bankruptcy. Tetraphase then surprisingly entered a bidding war between Melinta and AcelRx before a third suitor, La Jolla Pharmaceuticals, prevailed in June 2020.
The problems at Achaogen and smaller antibiotic companies typically are linked to pricing. Achaogen’s plazomicin was approved to treat drug-resistant urinary tract infections, albeit with a strong, black box FDA warning on safety. The company, which once held a market cap of $500 million, attempted to sell plazomicin for $14,000 per regimen in order to recoup its R&D investment. Reality bit, however, when hospitals and payers chose to cycle through broad-spectrum antibiotics on their respective formularies. Antibiotics on the formulary lineup may cost between $500 and $2,000. Plazomicin was not embraced, in spite of apparent patient risks.
Scientists estimate up to 70% of bacteria have developed a measure of resistance to at least one existing antibiotic. But which one? Physicians find out now mostly through trial and error, but the stakes can be very high.
An estimated 700,000 people worldwide now die due to antimicrobial resistance. Researchers estimate the total could rise as high as 10 million deaths per year by 2050. And last year, the CDC issued a report that identified five microbes as urgent threats and 11 others classified as serious threats.
Such figures could make the COVID19 pandemic seem small. In announcing its creation, the AMR Action Fund described antimicrobial resistance as “a looming global crisis that has the potential to dwarf COVID-19 in terms of deaths and economic costs.”
Summit Therapeutics (NASDAQ:SMMT) is advancing the antibiotic ridinilazole to treat C. difficile infection, one of the five microbes identified as an urgent threat by the CDC. Results of a phase III ridinilazole trial should be released in 2021. In a head-to-head phase II trial against vancomycin (the standard of care for C. difficile infection), ridinilazole recorded a superior clinical response (66.7% to 42.4%) compared to vancomycin.
Bob Duggan, an investor in Achaogen, recently became CEO of Summit. After watching the decline of Achaogen, Duggan believes to gain acceptance in the market new antibiotics no longer can settle for establishing they are non-inferior to the current standard of care. If they can demonstrate superiority, as ridinilazole appears to do so far, the new drugs can command premium pricing and acceptance.
The AMR Action Fund recognizes the problem and the imperative. It is expected to announce its first investments in partner companies before the end of 2020.