David's New Book

Sunday, October 23, 2011

Antibiotic Pipeline - Cautious Optimism

I am NOT reporting from the meeting of the Infectious Diseases Society of America (I have to justify every meeting expense these days).  But I did note an article in Medscape reporting on a discussion of the antibiotic pipeline by Helen Boucher and Jim Hughes of IDSA.  I devine that Dr. Boucher gave a talk similar to the one she presented at the Pew Charitable Trust/IDSA/PhRMA conference in September that I reviewed in a previous blog. She noted that, in contrast to a report in 2009, there are now nine compounds in late stage (phase II or later) development for Gram-negative infections.  She apparently stated that only one was in phase III development, but with the recent announcement by Astra-Zeneca and Forest on their bycyclo-octane B-lactamase inhibitor, avibactam (formerly NXL-104), there are now actually two in phase III. Dr. Boucher  correctly notes that none of the compounds are a panacea against all resistant strains.

Nevertheless, given the pace of discovery and development of new compounds, I think it is like that IDSA will achieve the goal of their 10x20 initiative where they targeted 10 new antibiotics approved by 2020.  When they announced this initiative in December 2009, I was skeptical (dismissive).  I thought it was a great PR move.  I now think that it could become reality.  But, I remain unsure that we will obtain FDA approvals for these new antibiotics in the key indication of hospital-acquired pneumonia, our area of greatest medical need.  For our progress or lack of thereof, see my previous blog. In her IDSA talk, as in the previous presentation for Pew/IDSA/PhRMA, Helen notes the uncertainty around FDA requirements for approval as a key hurdle to the availability of new antibiotics in critical indications for Americans.  This also remains a major disincentive for companies to either stay engaged in the area or to move back in or to start up. 

Back in 2009, at the time of the announcement of the 10x20 initiative, I had not considered the market dynamics that might end up saving us all.  That all changed when I was able to see 2010 antibiotic sales data as tabulated by IMS Health (see my slides from a talk earlier this year by following this link).  As I have noted repeatedly since then, while the US is still a large single-country antibiotic market, we are being overtaken by the emerging economies where the medical need is great and where there is a growing middle class who can afford to pay for new antibiotics of high quality (not “home grown”). I am not the only person to have taken note.  The Bayer deal with Trius is just one example of the fact that PhRMA companies now see emerging economies as an antibiotic opportunity.  

It is interesting, and perhaps inaccurate, that the Medscape coverage of the IDSA conference did not mention the GAIN (Generating Antibiotic Incentives Now) act.  The GAIN act originated in the House and has now been introduced to the Senate. As discussed in a very nice talk at the Pew/IDSA/PhRMA conference in September, Brad Spellberg showed how the additional years of exclusivity are heavily discounted in normal accounting practice and how this provides little if any financial incentive to companies unless they are bringing forward a compound with limited patent life.  (In that case, one wonders what they are doing . . .).  A report by the Office of Health Economics also debunks the idea that the exclusivity proposed by GAIN offers a financial incentive. I am personally not convinced that we need a financial incentive at this point.  I am convinced that a clear regulatory path in the US would be the most important incentive we could offer. It looks like the FDA is trying to get there – but why it is taking so long and why it is so painful, I cannot fathom . . .