What is happening to stimulate R&D and change the commercial model?
In the US, the Generating Antibiotic Incentives Now (GAIN) Act was passed to incentivize the development of new antibiotics in response to the growing threat of antibiotic resistance and a lack of antibiotic products in drug manufacturers’ pipelines. Under the GAIN Act legislation, companies may apply for QIDP (Qualified Infectious Disease Product) designation which offers fast-track status and priority review with the FDA, plus up to 5 years additional market exclusivity.
Many governments and charitable bodies worldwide are also allocating funds to stimulate research and development into new antibiotics. Two key programmes are:
- The US Biomedical Advanced Research & Development Agency (BARDA) Broad Spectrum Antimicrobials programme
- The European Innovative Medicines Initiative (IMI) New Drugs For Bad Bugs (ND4BB) programme.
Together these programmes provide direct financial support to nearly 20 percent of all antibiotics currently under development globally.
In 2016, CARB-X was launched as one of the world’s largest public-private partnerships focused on preclinical discovery and development of new antimicrobial products. This initiative intends to donate US$44 million in its first year and up to $350 million over the next five years in grants to small companies developing new antibiotics and diagnostics. The funds for CARB-X come from the US government and a public-private initiative in the United Kingdom and it aims to get at least two new drugs into human trials in the next five years.
Auspherix is a member of the BEAM alliance, a group of Biopharmaceutical companies from Europe innovating in AMR research. The Alliance is working to improve the regulatory, investment, and commercial environments for research, development, approval and market viability of new products combating antimicrobial resistance.