Applied Clinical Trials
The international pharmaceutical industry is addressing a familiar criticism of avoiding drug development in unprofitable conditions with a $1 billion partnership that aims to bring four new antibiotics to patients by 2030.
The international pharmaceutical industry stepped up its response on Thursday to the familiar criticism that it avoids drug development in unprofitable conditions-and that as a result the antibiotic pipeline is dangerously empty just as antimicrobial resistance soars. A score of companies announced the launch of the AMR Action Fund, a U.S. $1 billion partnership that aims to bring as many as four new antibiotics to patients by 2030. But the initiative-and the criticisms that have already emerged of it-are an early indicator of the sort of conflicts that are going to emerge in an even more acute fashion over payment for and allocation of any successful vaccines and treatments out of the massive injection of public and charitable funds into coronavirus research as Covid-19 continues to spread across the world.
The AMR fund will, say the founding companies, "save the collapsing antibiotic pipeline"-Almirall, Amgen, Bayer, Boehringer Ingelheim, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, LEO Pharma, Lundbeck, Menarini, Merck, MSD, Novartis, Novo Nordisk, Novo Nordisk Foundation, Pfizer, Roche, Shionogi, Takeda, Teva, and UCB.
Through the fund, pharmaceutical companies will join forces with philanthropies, development banks, and multilateral organizations to strengthen and accelerate antibiotic development, with a focus on "urgent public health needs." The money will support clinical research of innovative new antibiotics that are addressing the most resistant bacteria and life-threatening infections. The fund will also provide technical support to biotech companies in bringing their novel antibiotics to market.
The alliance, coordinated through the international body representing the R&D pharmaceutical industry, IFPMA, describes AMR as, "a looming global crisis that has the potential to dwarf COVID-19 in terms of deaths and economic costs." It says that each year 700,000 people are dying from AMR. In some of the most alarming scenarios, it is estimated that by 2050 AMR could claim as many as 10 million lives per year.
And it points to the "paradox" that despite the urgent need and the huge societal costs of AMR, there is currently no viable market for them. Because new antibiotics are used sparingly to preserve effectiveness, antibiotic-focused biotechs have declared bankruptcy or exited this space due to the lack of commercial sustainability, resulting, it says, in the loss of valuable expertise and resources. The result is a huge public health need for new antibiotics, but a lack of funding available for antibiotic R&D, particularly the later stages of clinical research, which creates a “valley of death” between discovery and patient access.
From the fourth quarter of 2020, the new fund aims to be in position to support innovative antibiotic candidates through the most challenging later stages of drug development, ultimately providing governments time to make the necessary policy reforms to enable a sustainable antibiotic pipeline, the industry statement promises. It will invest in smaller biotech companies focused on developing innovative antibacterial treatments that address the highest priority public health needs and make a significant difference in clinical practice. It will offer technical support to portfolio companies and give them access to the expertise and resources of large biopharmaceutical companies. And it will encourage governments to create market conditions that enable sustainable investment in the antibiotic pipeline.
According to Nathalie Moll, Director General of the EFPIA, “While much-needed policy solutions are explored by European policy-makers to address market failures in the antimicrobial area, the AMR Action Fund will help progress a pipeline of potential innovative medicines to treat infections caused by resistant bacteria”. But the fund statement insists that "policymakers across the globe must enact market-based reforms, including reimbursement reform and new pull incentives, to revitalize the antibiotics market and drive sustainable investments in antibiotic R&D."
The scheme has won the support of Dr. Tedros Adhanom Ghebreyesus, Director General World Health Organization, and Werner Hoyer, President of the European Investment Bank. But the initiative prompted warnings from prominent health campaigners. Médecins Sans Frontières dismissed what it called the business-as-usual approach of continuing to rely on the market-based R&D paradigm "that has largely failed to deliver new antibiotics." It contrasted the initiative of "the pharmaceutical industry, policy makers from high-income countries, and philanthropic organizations" with its own "serious challenges preventing, diagnosing and treating drug-resistant infections in the people we care for-from people living with tuberculosis in South Africa, to people with burn injuries in Haiti, the war-wounded in Syria as well as newborns in Pakistan." It makes no sense to keep trying the same thing and expect different results, it said in a statement. "What is needed to truly ensure faster development and access to new antibiotics is joint public and private cooperation prioritizing public health over profits," with "access conditions and stewardship principles embedded in such a venture."