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 Trust, one 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.