David's New Book

Tuesday, March 26, 2013

A Path Forward for New Antibiotics. Astra Zeneca Responds.


By Guest bloggers 

-     Bahija Jallal, EVP Research and Development, MedImmune
-          Briggs W. Morrison, Head, Global Medicines Development and Chief Medical Officer, AstraZeneca
-          Menelas Pangalos, EVP Innovative Medicines and Early Development, AstraZeneca
-          Manos Perros, VP and Head of Infection Innovative Medicines, AstraZeneca
-          Steve Projan, Senior VP Infectious Disease and Vaccines Innovative Medicines Unit, MedImmun
-       John H. Rex, VP and Head of Infection Global Medicines Development, AstraZeneca

In March 2013, AstraZeneca announced significant changes to our strategy and global site footprint. Going forward, we will concentrate our research investment on three core therapy areas (respiratory, inflammation and autoimmunity; cardiovascular and metabolic; oncology). In addition, we will remain active in infection, vaccines and neuroscience, where we will progress a more focused portfolio in addition to supporting our marketed products.

AstraZeneca has a significant presence in infectious disease R&D. Last year we brought to market ZINFORO (a new cephalosporin for the treatment of serious bacterial infections) and Q-LAIV (the first quadrivalent vaccine for influenza). As David Shlaes notes, our pipeline includes one of the most promising molecules in late-stage development, avibactam. And there is much more to be excited about in our earlier-stage portfolio.
But, the path forward for these promising new drugs is not easy. The challenging regulatory environment is well known — the usual approach to drug approval requires enrollment of thousands of patients into Phase 3 trials. As a result of significant interventions, important steps have been made to facilitate the regulatory pathways for new antibiotics so that increasingly efficient and cost-effective R&D is possible (The Lancet ID 13:269-275, 2013).
This progress on regulatory pathways is exciting but it is not enough. To ensure a steady of supply of use new agents, we must now turn our attention to the other major challenge of R&D for new antibiotics: reward for the investment made by the innovators.
Decades of R&D have produced a range of antibacterial agents which treat once deadly infections caused by bacteria that are not yet resistant. As available agents are often generic and relatively inexpensive, the expectation until recently has been that future antibiotics should be similarly priced.
We believe society will not have a diverse, vibrant pipeline of novel agents unless this pricing model changes. Drug development is costly and we must ensure developers are motivated to work on this challenge. Given the dramatic, curative nature of antibiotics and their corresponding societal value of returning years of life, an appropriate analogy can be made to premium pricing models now accepted for cancer therapies.
Underpinned by steps we have taken towards enabling a “personalized” approach to bacterial infection treatment, such premium pricing models are now widely discussed. As an example, at a 31 Jan 2013 roundtable hosted by the Pew Charitable Trustone participant noted that when a suitable antibiotic “... is given to the right population, I don’t think anybody’s going to have any issues about reimbursement.” (The Pink sheet 4 Feb 2013)

We are committed to continue work to prepare for this new treatment paradigm. Going forward, we must debate the following:

-          Right drug for the right patient: How will we diagnose the right patients for these new medicines, so that we apply effective stewardship?
-          Advanced diagnostic tools: What diagnostic tools do we need to facilitate effective stewardship, and who will bear the cost? How can we combine new diagnostic tools with new regulatory insights to further reduce the cost of development?
-          Valuing a new drug: How do we reward innovators so that return on R&D investment is attractive and competitive relative to other therapy areas? What data will payers consider as justification for reimbursement at premium pricing?
-          A global challenge: How will premium pricing models be adapted around the world? How can we ensure patient access to these therapies when needed? How will we work with prescribers and physicians to help evolve medical practice towards the new reality?

Antibiotics have an extraordinary ability to improve health: in many ways, modern medicine is made possible by antibiotics. We applaud the recent public comments by Dr. Margaret Chan (Director, WHO) and Professor Dame Sally Davies (Chief Medical Officer, United Kingdom) as these comments further raise public awareness in this matter and are now mobilizing key stakeholders to address the growing challenge.

As a community, we must ensure that suitable antibiotics are always available. Today's anti-infective environment is challenging and will require all stakeholders work together to make the business case so that R&D in infection is both attractive and competitive from a return on investment perspective. We are pleased to be part of that response.

6 comments:

  1. Right. If you can interpret this in a way that indicates where Astra-ZXeneca really stands and what it means when it says that antibiotics is no longer a core area - you are a better reader than I am. What I hear is that they are skeptical about the pricing strategies for new antibiotics that have already been discussed. But what this means for their future and for their products in development - I don't know.

    ReplyDelete
  2. My concern from this statement - antimicrobial prices will skyrocket given the short treatment courses. This will limit patient access, increase the spread of potentially deadly resistant infections, and ultimately not foster the R&D incentives they hope for on their investment. The real question is - when is the right thing to do more important than the capitalistic one?

    ReplyDelete
  3. Thank you for sharing your thoughts, which are similar to those of many others - David Livermore in particular. But basically, we have one choice right now - provide a return on investment for pharmaceutical company shareholders or go without new antibiotics. Even if we had publicly funded antibiotic research facilities, given the costs of R&D, I'm not sure we would come out ahead. And even if we would be somewhat better off in that circumstance, we are light years away from this as a real solution. Sorry.

    ReplyDelete
  4. I agree there are huge problems with the pipeline... However, the return on investment will not facilitate the growth of the industry and there is at least 5 if not closer to 10 years of lag. In a society (the US) where healthcare is a payer environment those whom can not afford the cost of antibiotics for currently non-resistant infections will simply forgo the treatment - this will likely harbor the infection and the spread of resistance. I appreciate that we live in a capitalistic world, but increasing the price for common treatments will not solve the problem. I have to agree with David Livermore on this... Having been an antibiotics researcher until funding forced me out of the field I also agree that we are rapidly approaching a time when thing will be irreversible.

    ReplyDelete
  5. I'm gratified that this has stimulated such a robust discussion. My fervent hope is that the US is moving away from a pay as you go healthcare system. Medicare and the large payers seem ready to pay the high prices we discussed for antibiotics. I think it is likely therefore that the insurance exchanges under "Obamacare" would do the same here in the US. The question is - will we pay the same price for life-saving antibiotics that we now pay for meagerly life-prolonging cancer treatments?

    ReplyDelete
  6. This is very important blog and i don't know well about antibiotic but when i study 3 -4 blogs then i know little about antibiotic. Today, people worry that in future bacteria will not be affected by antibiotics, because bacteria might evolve and become too strong.
    Thanks
    antibiotics to buy

    ReplyDelete