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Dr. Guy-Charles Fanneau de La Horie is the CEO of Pherecydes Pharma, a bacteriophage therapy company. He has over 20 years of experience in the pharmaceutical and biotechnology industries. Before joining Pherecydes Pharma, he held a number of international management roles, including posts at Schering-Plough, Biogen and IDM, in both Europe and the US.
What is the biggest question facing your field?
Antimicrobial Resistance (AMR) is going to be the number one killer in a near future as stated by a 2016 report authored by Jim O’Neill. This could result in 10 million deaths per year by 2050 and a cumulative cost to global economic output of $100 trillion (USD). On this basis, the death toll could be a staggering one person every three seconds and each person in the world would be more than $10,000 (USD) worse off . There are many reasons for this, including a widespread overuse and misuse of antibiotics in the health and agriculture fields. A critical reason is the lack of financial incentive for the private sector to develop new antimicrobials. Antimicrobials, when effective, cure patients and are sued for a short period of time when compared to chronic treatments in cancer and/or degenerative diseases and their cost is low. So the biggest question is how to make the development of new antimicrobials financially attractive.
The biggest question is how to make the development of new antimicrobials financially attractive.
Why is it significant?
Developing new treatments is very expensive. Recent estimates from the Tufts Center for the Study of Drug Development give figures as high as above 2 billion US$. Discovering new antibiotics is harder today than it once was, particularly those active against the drug-resistant Gram-negative infections that are of great concern. The ‘low-hanging fruit’ of easily isolated natural antibiotic products is gone. Clinical development is not simpler or cheaper for antimicrobials than for other therapeutic classes. All this explains why this area has been severely underfunded: Between 2003 and 2013, it has attracted less than 5% of venture capital funds! This underfunding is also true for public funds allocation: For example, the US National Institutes of Health (NIH), the world’s largest single funder of health research, allocated just 1.2 percent of its grant funding to AMR-related research between 2009 and 2014.
Where is the answer likely to come from?
There are two key ways to implement significant changes to make antimicrobials an attractive field for R&D:
· Review the regulatory pathway and alleviate the burden of proof-of-efficacy. Once safety is well-established, conditional approvals could be granted with the obligation of the companies to conduct efficacy studies in parallel with the commercialization of the antimicrobials
· Revise the financial incentive scheme: New antibiotics are rightly kept as last resort treatments, meaning that their sales volume are as small as possible during the first years. This is meant to reduce the emergence of antimicrobial resistance. This also means that the sales figures are minimal. A proposed scheme is to consider new antimicrobials as an insurance and therefore grant the companies a significant lump sum at approval (between 0.8 and 1.3 billion US$ has been proposed) with the obligation of conducting clinical studies and maintaining meaningful inventories.
This suggests that answers would come from the FDA and the EMA for the first point.
IMAGE SOURCE: Pherecydes Pharma