Sunday, January 3, 2016

2015 - Year in Review

The highlights of the year 2015 for me begin with the discovery of the iChip technology by Stava Epstein and his colleagues in Kim Lewis’ lab. This technology allows the growth of previously non-cultivatable antibiotic-producing organisms from soil by simply isolating them and placing the back in the soil environment from which they came. Its elegant and holds much promise for the discovery of novel natural product antibiotics in the future. We are all awaiting further developments here.

The output of reports from Jim O’Neill’s Review on Antimicrobial Resistance continues to amaze me even if  I don’t agree with all their conclusions. The idea that incentives for the discovery and development of antibiotics could actually become reality in my lifetime is nothing less then a breath of air after the stifling nightmare of the last 15 years. I have been so inspired that I have joined the Drive-AB effort to help make this dream come true.

This year finally saw the results of Astra-Zeneca’s efforts to sell its antibiotic research, development and business franchise.  Being unable to obtain the price they were demanding (one presumes), they adopted a different strategy.  This year they spun out their discovery group into a company, Entasis, fully funded to the tune of $40 million by the mother ship (AZ).  Shortly after that, they announced the formation of an independent business unit within AZ that would encompass their antibiotics business and as well as their clinical development group. What will happen to them is still to be determined – but I will have more to say about this in the next week or so.

A big highlight for me this year, and I hope for you, too, was the appearance of my new book – The Drug Makers.  I have been gratified by the many positive comments I have received from those within and from many outside of the pharmaceutical industry.

On a down note, Tetraphase reported that their phase III trial of eravacycline for complicated urinary tract infection failed to meet its endpoint. I was especially disappointed in this news because I helped them design the trial and thought that we had done everything to assure its success. Luckily, I own no Tetraphase stock since it crashed by about 80% with this news. I am still hoping that eravacycline will make it to the marketplace since we desperately need an effective, oral antibiotic for resistant Gram-negative infections.  Eravacycline is the only drug fitting this bill on the near term horizon.

On another low point, I discussed the effect of increasing drug prices, especially for generic drugs, on public opinion and even on pharmaceutical company stock prices and on the political campaign. I suggested that the US should adopt two simple (but politically fraught) policies to deal with this issue.  (1) We should subsidize alternative manufacturers for essential medicines to prevent price gouging. (2) The US should finally begin to negotiate drug prices nationally at least on a federal level just like virtually every other country in the world.  This is guaranteed to control prices.  While some argue that it will reduce innovation globally and here in the US, I remain unconvinced and believe we should do the experiment.

There have been important issues in the FDA reboot of antibiotic development this year related to antibiotics active only against specific pathogens. I discussed this with FDA this fall.  Their problem is that they believe that they need some sort of inferential data to approve a new drug while I think there are lots of examples where this has not been the case. They are pursuing this with the President’s Advisory Council on Combatting Antibiotic Resistance. Once again, I await further developments here and you can look forward to additional blogs on this in the future.

The recent announcement of the proposed merger between Pfizer and Allergan was the subject of a blog and a recent Lancet article. My worry is that Allergan’s key antibiotic pipeline for North America based on the beta-lactamase inhibitor, avibactam, will be in jeopardy because of this merger. Pfizer is not known for its enthusiasm for antibiotics these days.

A recent court ruling suggesting that the promotion of off-label uses for drugs was protected speech raised my hackles.  If this ruling ever becomes the law of the land, it will mean that companies can sell anything for anything. Lets not go there – please.

Finally, the recent emergence of mcr-1, the plasmid-mediated gene encoding resistance to our very last line Gram-negative antibiotic polymyxin (colistin) scared the hell out of me. The gene has now been found in Asia and in Europe after having apparently emerged in China.  Why did this occur?  Because in China (and apparently here in the US) polymyxin can be used and has been used as a growth promoting agent for pigs and/or cattle. In an editorial, Josh Bloom and I suggested that this practice must stop and must stop globally.

With that, I wish you all a happy, productive and very safe 2016!

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