DefinedHealth

Timothy Joslin, BSc

Antimicrobials were the mainstay of revenue and promotion for a large number of pharmaceutical companies up until the early 1990’s: e.g. GSK’s Augmentin, Bayer’s Cipro, Abbott’s Biaxin/Klacidand Pfizer’s Zithromaxand Diflucan– all billion dollar drugs in their own right. The potential for multi-billion dollar markets for chronic diseases treated in the primary care space subsequently made a number of companies reconsider their strategic interest in the area of infectious diseases. To wit, Aventis and Roche spun out their antibiotic R&D efforts and left the field entirely. During the last few years antibacterials and antifungals have been largely
ignored by Big Pharma.

That having been said, the market for antibacterials is projected to grow by $1 billion in sales in the next 5 years (+6% growth) toreach a total of over $17 billion by 2012. This growth is driven by 5 of the top 10 selling antibiotics collectively adding $4 billion during 2006 to 2012 and offsetting the decline in sales due to patent expiry from previous billion dollar products. Winners among the currently marketed agents are predicted to be Zyvox(Pfizer, 2012 sales of $1.4 billion, a doubling of sales since 2006); Tygacil (Wyeth, 2012 sales of $600k from launch in 2006) and Cubicin(Cubist, 2012 sales of over $600k from under $200k in 2006). Of
these three products, only Zyvoxis from a completely new antibiotic family. Of those antibacterials currently in pre-registration/late stage development, J&J is predicted to have the top two products by 2012 – ceftobiprole (est. $1 billion) and doripenem (est. $600K). Again, these two products are variations of old themes and not new classes.

A renewed interest by some companies in the antibacterial space prompts the question as to whether it is time for Big Pharma en masseto rejoin the game. To answer this, we must determine whether there is sufficient unmet need to justify a research effort to produce novel, premium-priced compounds, and whether the bar can be moved by novel compounds that surmount the present resistance problem. The ongoing press on ‘superbugs’ in US and EU would suggest that we could be returning to the pre-antibiotic era of the 1940’s. If it is not community-MRSAthat will cause our downfall then the growing incidence of C. difficle or Acinetobacter will surely finish us. Is this true? More importantly, can we find ways to profitably combat these threats? Who will win out? Will it be the more traditional approaches currently in development like Novexel’s NXL 103, or Aprida’s iclaprim? Or is the future direction for antibacterials typified by AvidBiotics and their interest in pyocins, an alternative way to eradicate pathogenic bacteria without the risk of resistance? Will Big Pharma be able to re-start productive R&D projects or will they have to buy into the new market through acquisition of Biotech’s successful efforts?