There are many important developments occurring on the
antibiotics front. Progress in regulation, especially by the FDA, continues.
Push incentives are gaining even more steam. GARDP recently announced an
agreement to pursue a novel therapy for Neisseria
gonorrhea infection. But I am staying focused like a laser on the issue of
pull incentives because I consider this our greatest and most urgent challenge.
Recent data suggests that recently approved antibiotics are
not earning anything like the kind of revenues that new products in other
domains such as neuroscience (multiple sclerosis, Alzheimer’s) or oncology
currently garner. $80 million per year seems good for these new antibiotics. According
to the Boston Consulting Group's report for the GUARD initiative, for recent antibiotic launches, the net present value
projected over 10 years is estimated at minus $500 to minus $100 million. This compares to minus $450 million to plus
$8.2 billion for recently launched oncology products. Obviously, for antibiotics, this makes no commercial sense.
DRIVE AB, an effort funded by the Innovative Medicines
Initiative – an effort jointly funded by the European Commission and the
European pharmaceutical industry, just published a commentary in Lancet
Infectious Diseases (subscription required – why??!! – sorry) where they
provide a hint as to what will be appearing in their final report. The final report is expected sometime around
September this year. The commentary, published a week ago, is in the form of an
open letter to the G20, whose meeting recently ended. They suggest a market
entry award that is fully or partially “de-linked” (from marketing
requirements) in the amount of $500 million to $2 billion paid out over 5 years
would be a sufficient pull incentive. The range exists because they would deduct any
research and development funding the company had received for the product prior
to launch. There could also be
deductions (or rewards) depending on the innovativeness of the new compound or
how well it fits into current medical need priorities. They promise that their full report will
provide a rationale for this. I’m not sure that anything less than $1B will
work under any circumstances – but that’s just me.
In their open letter, DRIVE AB asks the G20 to establish
market entry reward trial programs or pilots to better understand how different
models would work on implementation. I’m
at a loss to see how one could set up a “pilot.” I think you would have to fully fund several
different programs to see which one would attract the most or best candidates
or which one would best motivate the industry to remain in or restart
antibiotic research. But we await Drive AB’s final report here.
Concurrently, in collaboration with
relevant experts including from the OECD and the WHO, we will further examine
practical market incentive options.
It
seems like the G20 will fall back on the “we need more studies” response that
was enshrined in the plan recently released by the European Commission (see my
last blog). I guess that was predictable.
But
here is the problem. Given the persistent market failure as documented by
sluggish sales of new antibiotics that are active against resistant pathogens,
pharmaceutical companies that are still active in antibiotic research are
surely having second thoughts. We may see more departures. Investors, seeing
this market failure, are going to become more reticent again after a recent
resurgence of interest fueled by optimism regarding both push and pull
incentives.
We
need to act now. Not in ten years. Lets not wait for another global pandemic such
as the one we experienced with MRSA. Please. I ask all of you to write your
representatives in government. In Europe
– this means your parliamentarians, your executives, your health authorities,
and anyone else you can imagine. In the US – talk to your representatives, your
senators, Tom Price at HHS. Let’s get the Infectious Diseases Society even more
active than they already are. Let’s start publishing our own open letters that
speak to the urgency of this issue.
We
need to start drowning our governments with our sense of urgency here before we
fall further into the abyss.
No comments:
Post a Comment