Before getting into
the topic of today’s blog, I wanted to wish everyone a happy Passover and
Easter. I hope that our thoughts of renewal this weekend will extend to the
impending antibiotic resistance crisis.
Today I spoke with Dr. Adrian Thomas, an Australian
physician, who is now the Vice President of Global Public Health for Johnson
& Johnson. As you may know, J&J
has performed yeoman work in the area of tuberculosis
and, more recently, Ebola.
The company has a major investment in medical devices especially around
surgery. They recognize the implications
of antimicrobial resistance for their device business. Surgical implantation of devices in
orthopedics, both electively and emergently, and, in the future, from the use
of robotics in surgery are areas clearly at risk from emerging antimicrobial
resistance.
As I did during my interview
with Pfizer, I tried to get Dr. Thomas to provide me with a specific incentive
or even a specific monetary amount as to what J&J would expect from a pull
incentive in order to invest either in antibiotic discovery research or in the
development of a late stage asset. The
reply I received was not what I expected.
Dr. Thomas pointed out that J&J is a science-driven company. Therefore, that any opportunity they might
explore would depend on whether they had the scientific expertise to maximize
the opportunity. (I wonder if J&J still has the internal scientific expertise to evaluate antibiotic assets). Only when that
criterion was satisfied would commercial considerations come into the picture.
He also noted that the requirement for the size of a pull incentive might be
quite different depending on the specific product and its spectrum of activity.
The most difficult of the products might be those where the smallest numbers of
patients would be treated. Therefore,
one would be developing a product that would, essentially, be used only very
sparingly.
I also asked what kind of pull incentive would be preferred
by J&J. Once again, he responded
saying that it would depend on the specific product and that this is a
complicated topic. He pointed out that
different pull incentives might be required in different markets globally. Dr.
Thomas provided an example of a
priority review voucher that they received upon approval of their TB drug in
2012. They used this voucher to
accelerate approval of a drug
to treat psoriasis – a particularly competitive area. For them, this was an
important pull incentive. This pull incentive was then ploughed back into
public health related research according to Dr. Thomas.
In discussing pull incentives generally, Dr. Thomas pointed
out the importance that J&J would place on innovation in the award of such
incentives. He also pointed out than any such incentive, according to J&J,
should be accompanied by appropriate guardrails. But when I asked what they would look like,
he demurred suggesting again that such questions could only be answered on a
case-by-case basis. There is no specific answer here from J&J, he said. The
other need he emphasizes is that companies need to be able to recoup premium
pricing on drugs that are rarely used. (Recent launches have not been encouraging in
this regard - my thought here).
Dr. Thomas also expressed some skepticism around the
regulatory process that might be adapted for approval of rarely used
antimicrobials targeting resistant pathogens. He noted that the pivotal trials
for their TB drug took 3-5 years to complete.
Finally, Dr. Thomas noted the concern that I think all of us
share. In the absence of defined
pathways not only for approval, but more importantly, to success in the
marketplace, investors are hesitating.
My recent conversations with key investors in this space confirm that
this is a real concern. Dr. Thomas noted that there is a dearth of potential
partners for drugs acting against resistant pathogens (partners that would interest
J&J, I presume he means).
In summary, like other large pharmaceutical companies such
as Pfizer, J&J believes that pull incentives as well as premium pricing are
a necessary part of fixing the broken market for antibiotics targeting
resistant pathogens. Dr. Thomas would
not provide details on preferred pull incentives or the amount of compensation
that would be required. He maintains
that it all starts with the science and with J&J’s internal expertise and
that commercial needs would have to follow on a case-by-case basis. That said,
he noted that J&J was pleased with the priority review voucher they received
for their TB drug.
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