Thursday, September 22, 2011

Antibiotics in 2020 - A Vision - Reporting from the Pew Charitable Trust

microscopic image of Pseudomonas aeruginosa (A...Image via Wikipedia

This is the first installment from a fascinating meeting at Pew Charitable Trust, September 22, 2011

  • ·      Revenues from Antibiotic sales in Asia-Pacific (not Japan), Russia, Brazil and South America will exceed those in the US by at least 200%. We might even meet the IDSA goal of 10 by 20 – just not in the US.
    • o   The medical need for therapies for multi-resistant Gram negative infections are as great or greater than the need existing in the US.
    • o   There is a growing middle class who will be able to afford these new therapies.
  • ·      Driven by these sales revenues, there will be six large pharmaceutical companies actively pursuing antibiotic R&D by 2020 compared to just 2-3 today.
  • ·      This growth is made possible by a flexible and balanced regulatory environment in Europe where approval for antibiotics in key indications such as respiratory infections remains feasible. These approvals then drive approvals in the rest of the world outside the US.
  • ·      This bright future leaves the US in perpetual antibiotic darkness.  While the Chinese, Koreans, Russians and South Americans have access to approved new antibiotics active against resistant infections, Americans do not.
  • ·      In the US there remains no feasible regulatory path for key infectious diseases indications where there is a high medical need such as hospital-acquired pneumonia. 
  • ·      If the new antibiotics are approved in the US for an indication where the trials are feasible, Americans would only have access to therapy for pneumonia via off-label use. 
    • o   The off-label use, however, would be paid for by Medicare and other payors in the US based on medical need.
  • ·      The lack of a significant market in the US in 2020 has led to an innovation drain.  Much of the antibiotic R&D has moved to Asia where the revenues are and where a growing entrepreneurial class has taken hold.
    • o   Antibiotic research in biotech and academia is flourishing with ample opportunities for partnering with large pharma and even for accessing the public markets.  But these companies do not flourish in the US – but rather in Europe and especially in Asia.
  • ·      At the beginning of the decade (that is, today), BARDA showed that they could support even phase III trials providing a very important incentive for the industry to continue or even restart antibiotic R&D. But that effort fizzled before 2020 since no novel therapies could be approved by the FDA even though the same drugs were approved in Europe.
  • ·      But this vision might just be a nightmare.  We could wake up to a different future.  The first step must be that the FDA must provide a feasible regulatory path for antibiotics in key indications such that new products can be approved here in the US.  No amount of monetary incentive can overcome this regulatory roadblock.
  • ·      If we do not act now, the US will be left on the sidelines.  Antibiotic R&D in the US and in fact the US antibiotic market altogether will be irrelevant compared to the rest of the world.  And Americans will pay a high price for our lack of foresight today.

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