The BEAM Alliance, a coalition of small and medium-sized biopharmaceutical companies, is requesting urgent action be taken in the fight against resistant bacteria by asking political leaders attending the G20 summit to work together to fight this deadly problem.
Antimicrobial resistance
At the G20 Summit in Hamburg, political leaders are discussing the growing global health threat of antimicrobial resistance (AMR). The rapid growth of multidrug-resistant bacteria, known as superbugs, has become a very hot topic, driving an urgent need for new antibiotics.
“If nothing is done to thwart the progression of anti-microbial resistance, it will equate to a potential global economic burden of up to $100 trillion by 2050,” Florence Séjourné, president of the BEAM Alliance stated in a press statement, citing estimates from the 2016 O'Neill-report.
The current situation has come about from the overuse of antibacterial agents developed during the second half of the 20th century. Despite continued attempts to thwart the resistance, bacterial infections are becoming more and more difficult to treat.
Member companies of the BEAM Alliance are geared towards developing cures for the treatment of severe bacterial infections, ensuring antibacterial therapeutic options for the future. Currently, there are more than 100 antimicrobial products in the pipeline from the members of the alliance. These range from early stage preclinical studies to clinical development phase.
However, as the BEAM members are small to medium enterprises, funding is constantly an issue, leading the alliance to call for immediate action.
“Numerous national and international reports have today suggested a range of different incentives policies to stimulate innovation in antimicrobial resistance. We urge the G20 leaders to take immediate action to mandate member states to implement concrete measures including push- and pull-mechanisms and to simplify the access to available funding in order to help revitalize the industry,” Séjourné continued. “In this way, we can thrive developing innovative products to combat antimicrobial resistance.”
To revitalise and replenish the antibacterial R&D pipeline the BEAM Alliance proposes short-term actions to be mandated immediately by the G20 leaders and a long-term strategy to tackle AMR now and in the future.
Action #1 — Implement PULL incentives: Require robust market incentives to be implemented nationally (e.g., tax breaks, longer market exclusivity, revised pricing models) and as a key element, a globally co-ordinated Market-Entry-Reward (MER) system with the early-designation (similar to the Qualified Infectious Disease Product designation in the US) of eligible compounds, which guarantees an appropriate return on investment. Implemented systems should be reviewed regularly and adjusted to ensure effectiveness, with a goal to evolve and harmonize globally.
Action #2 — Implement PUSH incentives: Expand available funding to antibacterial R&D activities and significantly improve accessibility to SMEs. Currently available government funding, including EU funding, is geared towards the needs of big pharma requiring participation in a complex consortium and incurring significant administrative and managerial burden. The availability of substantial non-dilutive financing more tailor-made to suit the needs of small and medium-sized biopharmaceutical companies is required, with a focus on funding early-stage projects (discovery to clinical proof of concept).
Action #3 — Further improve the regulatory pathways: Require national health authorities to define accelerated and simplified pathways to allow the development and approval of innovative products tackling antimicrobial resistance. Crucially national authorities should continue efforts with a goal to globally harmonize clear-cut regulatory guidelines to develop antibacterials, which would include adaptive trial designs for novel innovative approaches (e.g. small molecules, biologics, prophylactic, diagnostic, immune-targeting, microbiome-based, phage-based therapies, anti-biofilm agents etc.) which many SMEs are developing.
Long-term strategy — Recognize the societal value of antimicrobial medicines: All stakeholders especially the governments, regulators and payers must re-align on approaches, which appropriately recognise and measure the societal value of antibiotics to combat AMR since this value surpasses the individual direct benefit. Such value should be reflected in any payment and incentives models. Complementing this dedicated and concerted actions must be implemented to nurture a vibrant R&D environment for new antimicrobials at all levels: a strong expertise at every stage of the antibacterial drug development should be preserved in Europe, especially since the industry has faced decreasing investments in the antibacterial field.