The news
this week is that Astra-Zeneca, as part of its downsizing effort, will cut its
investment in antibiotic R&D. This has to be one of the most disappointing
developments since Roche first left the field in 1999. They will, however, continue to support their
efforts in oncology. This misguided misreading
of the opportunities is yet another demonstration of the sclerotic thinking of
large pharmaceutical companies. These
executives and their commercial leaders are stuck in a world that no longer
exists. What they fail to understand is
that antibiotics IS the new oncology!
The regulatory world of antibiotics is changing quickly and
radically. It will now be possible to
develop antibiotics more quickly and with less expense than ever before. And,
developed correctly, payers are ready to pay oncology prices for new products
(see this blog). More opportunities for non-dilutive support
for antibiotic R&D exist now than ever before and some of these large
grants can pay for pivotal trials. Astra-Zeneca
has been the recipient of some of these grants. None of this existed 10
years ago – where the large pharma executives still seem to hiding in a time
warp.
Antibiotics remain less risky and more likely to succeed
once they enter development than products from almost any other therapeutic
area.
And that the decision to cut antibiotics R&D is coming
from Astra-Zeneca seems all the more incongruous. Their infection development leader, John Rex,
has been at the forefront of all of the discussions with regulators and with
payers where these opportunities have become clear. John has been a leader in devising
the rapid development plans that could get us to oncology prices.
While one can understand the plight of large companies like
Astra-Zeneca, whose big products are being rapidly eroded by generic
competition, it remains hard to understand their decision making process. Although
I can imagine exactly what happened. AZ executives
looked at the potential gains from oncology and cardiovascular drugs and even
when adjusted for the risk of development they still dwarf gains (in the past)
for antibiotics. But of course I am sure
that they did not factor in the kind of prices antibiotics will now command,
they failed to account for the lower development costs they will incur and they
probably underestimated the risks of their efforts in cardiovascular medicine
and oncology.
At the same time, Dr. Margaret Chan and Dame Sally Davies of
the WHO and England respectively, are warning about a post-antibiotic era where
we will live in a world where mundane surgical care will no longer be possible
without extraordinary risk in the absence of antibiotics active against
resistant pathogens. While I still
believe that this is somewhat exaggerated, the loss of one of the stalwarts of
antibiotic R&D over the last decade will be a tremendous blow to our
efforts to avoid such a calamity.
The loss of company like Astra-Zeneca will reverberate
throughout the pharmaceutical industry.
Private investment in antibiotics will plunge further in the absence of
yet another potential large pharmaceutical partner for academia and biotech. Biotechs
and academics with advanced projects will struggle even more to partner their
late stage products that they cannot advance into pivotal trials.
It is possible that I am over-reading AZ’s statement to the
press. Perhaps spending less does not
mean they are getting out of antibiotics R&D. Maybe they will be able to continue robust
discovery and development activity in spite of the cuts. But long experience (Pfizer, J&J, Wyeth,
etc, etc) has shown that when a company
says that a particular therapeutic area is no longer a high priority, it
forshadows the complete amputation of that area.
I would like to remind Astra-Zeneca that if and when they
consider their amputation of antibiotic R&D, that they remember that there
are other good alternatives to simply cutting and burning. There are spin offs and other out licensing
opportunities that could be utilized.
Astra-Zeneca has one of the most important assets in the late stage
antibiotic pipeline – avibactam. Their first priority must be to get this new
product to the patients and physicians that need it.
I'm not surprised. In the UK, AZ launch ceftaroline and we say it's a cephalosporin so we can't use it. Regional benchmarking showed no difference in Cdiff rates based on cephalosporin usage rates. We need to have more diversity in our patients, and avoid higher risk antibiotics in higher risk groups where possible.
ReplyDeleteI guess I find that a little hard to understand. If ceftaroline really works for MRSA (and it looks like it does) then who wouldn't want to use a cephalosporin that is safer and may be more efficacious than a glycopeptide? But then, the UK is starting to look a little like Japan to me - inscrutable.
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