I was inspired this week by a few news articles and blogs that appeared
recently. One in particular was a piece
by Maryn McKenna, author of Superbug.
She writes about the frustration of activists dealing with political and
social inertia. I have spent the last several years discussing the perfect
storm of factors working against the discovery and development of new
antibiotics needed in our fight against antibiotic-resistant pathogens. It is
fair to say that the last 10 years have been mostly downers in this
regard. So I can certainly
empathize with the difficulties of trying to move boulders uphill.
But I also have my own moments of optimism (perhaps misguided) – like now. Over the last year we have seen the European
regulatory agency, EMA, leading the way to the feasible and rational design of
clinical trials to support the approval of new antibiotics. The FDA has said they will reboot their
entire process (which probably cannot get worse) (famous last words). Since regulatory reform was one of the
key potentially reversible roadblocks to the development of new antibiotics, I
believe these developments are very positive and I am becoming optimistic about
the future of antibiotics.
We have recently seen very significant government investments in
antibiotic R&D including funding through BARDA to cover at least a portion
of the expensive phase III trials to get antibiotics to market approval. GSK
was awarded
nearly $100 million in support
of its ‘052 antibiotic active against many resistant pathogens (unfortunately, those trials have now
been halted). Tetraphase was
awarded up to $67 million in support of TP-434 (see below). The Innovative Medicines Initiative in
Europe has also just announced similar important investments in antibiotic
R&D (see the last blog).
These very important investments provide additional, clear incentives for the
continued discovery and development of new antibiotics.
Another source of optimism to me is the continued rapid growth in
antibiotic sales in the emerging markets. Antibiotic sales in these markets
have already outpaced the US market by over 30% and are rapidly approaching the
point where they will be equal to Europe and the US combined. These markets will become more and
more attractive to companies who are poised to exploit them. This indicates that more companies will
re-enter the antibiotic R&D arena as Sanofi-
Aventis has recently done. To me, this makes the patent extension included in the GAIN act (recently signed into law by President Obama) totally irrelevant except for those small companies who are developing products with otherwise short patent lives.
Aventis has recently done. To me, this makes the patent extension included in the GAIN act (recently signed into law by President Obama) totally irrelevant except for those small companies who are developing products with otherwise short patent lives.
We now have a number of antibiotics that will be effective against at
least some of the most fearsome resistant Gram-negative pathogens in the late
stage pipeline. These include ceftazidime-avibactam
from Astra-Zeneca which will be active against KPC-producing organisms resistant
to carbapenems and virtually all other antibiotics and ceftolozane from Cubist – a
drug active against many highly resistant Pseudomonas strains. Tetraphase should soon be
completing their phase II study of TP-434, a tetracycline active against many
multiply-resistant Gram negative pathogens including Acinetobacter and which is
available orally as well as IV. There are other antibiotics about to enter late
stage development with complementary activity against other multiply-resistant
pathogens as well.
So, I am now in one of my more optimistic moods regarding the future of
antibiotic R&D. But of course
this all depends on; a successful FDA reboot; a large PhRMA industry that sees
an advantage in rising antibiotic sales in emerging economies in spite of their
continued need to slash and burn to make up for patent losses; and perhaps,
even on welcoming public markets for small biotechs desiring to go it
alone. So, I guess I am a somewhat
cynical optimist after all.
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