Novel Antimicrobials and AMR Diagnostics 2019


Are novel antibiotics worth investing in?

Overview about current discussion about Push and Pull incentives/ New initiative started by SMEs to propel preclinical research

In autumn, stakeholders across the globe pledged to take more action in the fight against antimicrobial resistance (AMR). Whereas from the “push” side new public and private initiatives appeared on the screen, discussion about which “pull” mechanism should be started first is in full swing. Meanwhile, small and medium-sized companies combine forces aiming to propel preclinical and early clinical R&D.

The news spread like wildfire in the AMR community: Exactly one year after US-based Melinta Therapeutics executed a US-$270m pact to buy out the Medicines Co’s infectious disease group – one in a string of pipeline expansion deals – the Connecticut-based drugmaker reported it had reduced headcount at its headquarters, laying off 22 out of 25 staff members and spinning out research projects. “Sad, but not unexpected news,” commented Kevin Outterson, head of US-based financing vehicle CARB-X, on Twitter and added: “Does anyone need more proof that the way we pay for antibiotics is thoroughly broken and we need delinked reimbursement reform immediately?”

G20 leaders urge for action

Only two days later, G20 leaders in Argentina released their final declaration, underlining the need for urgent action: “We note the work done by the Global AMR R&D Hub and, drawing on this, we look forward to further examining practical market incentives.” In the AMR community, this message was well-appreciated; however, rather than examining the options, the implementation of pilot measures would be preferred by most stakeholders. Particularly because there is, in principle, no lack of ideas about how to spur up the antibiotics market with market incentives. In mid-September, the US-regulatory body FDA unveiled its “2019 Strategic Approach for Combating AMR” under the umbrella of the “Global AMR Challenge” initiative, launched at the United Nations General Assembly and bundling together the commitment of over 100 organisations in the fight against AMR. “It is important to pursue new policies and reimbursement approaches now, to shift the investment landscape right away. One constructive way would be to develop innovative payment mechanisms that allow companies to capture a greater upfront share of the social value of antibiotic drug development,” FDA commissioner Scott Gottlieb said during the kick-off event co-hosted by the Bill & Melinda Gates Foundation, the Pew Charitable Trusts, the United Nations Foundation, Wellcome Trust, and the CDC Foundation. Although Gottlieb lauded the accomplishments of existing “push”-style incentive programmes, such as the Generating New Antibiotics Now (GAIN) Act and the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD), in generating new drug R&D, he noted that in spite of these efforts only 11 antibio-tic products that are designed to address the most-threatening pathogens, as identified by the World Health Organization (WHO), are currently in clinical trials.

Read the full article here at European Biotechnology Magazine