I apologize for the time lapse – but we were down in
Columbia visiting John Quinn’s family there and the research institute where he
worked with his widow, Maria Virginia. She is still carrying on the battle against
resistance. Keep your eyes on this blog
for an update.
In the last few weeks, there has been some media attention
to the problem of resistance. I am
ignoring the constant discussion over the use of antibiotics in animals since I
consider that what needs to be done is obvious and that the FDA just has to do
it. But I did want to explore some of the press recently on antibiotics for
humans.
First, there is a blog by Tim Fothergill, a microbiologist,
in the Huffington. Basically he notes that we have a problem
with superbugs and says he will talk about solutions in his next blog . . .
Then there was a report of a meeting at Harvard
featuring some luminaries like Stuart Levy. They address the same question but
stick to old tunes like stop using antibiotics (good idea but this won’t be
enough) and prolonging exclusivity on sales of new antibiotics. The latter has been shown clearly to be
insufficient to attract companies back to antibiotic R&D unless they happen
to have a drug or drugs with a relatively short patent life.
Finally, with a breath of fresh air, Matt
Herper wrote a piece in Forbes talking about the importance of premium
pricing for antibiotics. Now we’re
talking. For superbugs, he suggests a
super price! Yes boys and girls, we will
get what we pay for. If we want to be able to continue to have antibiotics that
work then we will have to pay a price - as in money - ka-ching! Anyone who tells you different is living in
Colorado and smoking something.
It seems that not only large pharma, but venture capitalists
as well, have figured out that the new regulatory pathways and talk of
super-pricing make antibiotic R&D an attractive investment again. The old
Rib-X, now called Melinta, announced
a new round of funding of $70 million to develop delafloxacin. Delafloxacin is
a quinolone antibiotic that is orally available (you can take a pill) and
active against some Gram negatives but also against MRSA. The problem is that, as a quinolone, you take
a 40% chance that it will fail either during late stage development (phase III)
or post-launch. My belief is that it is for this reason that no pharma company
has jumped in to partner the drug – they are all waiting to see what
happens. But the fact that Melinta
continues to be able to raise money to support the development of delafloxacin
says something important about the appetite of private investors for antibiotic
R&D.
At Astra-Zeneca, it seems to be the head-in-the-sand
approach to antibiotic R&D. In a piece of potentially bad news (at least
sad news), Astra-Zeneca
announced that it was closing its site in Bangalore, India where they
carried out research to find antibiotics against TB and Malaria. On the one
hand, since such products are unlikely to contribute to AZ’s bottom line, we
can understand this decision. The
question is – what does this augur for the rest of their antibiotic R&D in
Waltham, MA and Wilmington, DE. In spite of the most promising antibiotic
pipeline in the industry, they have already announced that they will focus on
key areas like cardiovascular to the exclusion of non-key areas like
antibiotics. We await further
developments here – but I’m worried. It
seems that the forces that are driving private investors and other large pharma
companies towards antibiotic R&D are not influencing AZ’s management one
iota.
No comments:
Post a Comment