Big PhRMA + FDA = Antibiotics?

I recently read an article noting that Abbot is splitting into two separate companies.  I have been saying that the large pharma model is dead for a long time now. In the case of Abbott, one company will retain the name Abbot and be a company focused on medical devices, generics, diagnostics and nutritionals. The second company, name unknown, will focus on Abbott’s $18B ethical pharmaceutical business.  Of course, like other pharma companies, Abbott’s business is threatened by generic intrusion.  Their largest product, Humira, is threatened by biosimilars.  On the other hand an $18B company is easier to grow than a $32B company. This move is similar to that of Pfizer and Bayer (back in 2006). I remain hopeful that all these large behemoths will shrink, split, divide or whatever it takes to reduce their overall bottom line to the point where antibiotics again become an attractive business.

In this regard, I note a new report from the Tufts Center for the Study of Drug Development that anti-infectives (excluding antivirals) once again have among the fastest times to approval and lowest risk of development compared to other drug classes.  This is a change from their last report from around 2003. I am surprised given the recent rate of late stage antibiotic failures at FDA and the poor approval rates for antibiotics over the last few years at FDA.  One caveat is that the latest report still only goes through 2009.

If the FDA can turn around their current unrealistically demanding approach to antibiotics, and if companies can succeed in shrinking enough, antibiotics could be in for a big comeback!

Speaking about the FDA, two key anti-infectives advisory committee meetings are coming up this week. Stay tuned.

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