India's new clinical trial rules establish an accelerated pathway for new drug approvals, but affordability remains… https://t.co/uhVXDZGLfr
Will the latest UK-lead review into antimicrobial resistance help revive greater interest from pharma?
A BBC documentary entitled Antibiotic Resistance Crisis opened my eyes to the extent of the imminent disaster that is unfolding with the continued indiscriminate use of antibiotics. It was heart rendering to watch a paediatrician in a neonatal unit of an Indian hospital desperately trying to save the life of a premature baby with a last resort antibiotic combination. On the flip side, the documentary exposed how the growing resistance to antibiotics is associated with the ease in purchasing them in emerging economies as over-the-counter products.
This is an issue I also encountered during my research into the Saudi Arabian market as part of our latest multi-client study on Market Access in the Middle East: How Pricing Reform Impacts Pharmaceutical Uptake Strategies. In breach of Saudi Arabian legislation regulating retail pharmacy practice, most medicines -including antibiotics- can be easily purchased without a medical prescription. This practice has in turn facilitated self-medication that has become commonplace in the largest Middle Eastern pharmaceutical market mainly due to dissatisfaction with the healthcare system, including unavailability of services when needed.
Internationally renowned economist Jim O'Neil is currently leading an international Independent Review of Antimicrobial Resistance (AMR) commissioned by UK's Prime Minister David Cameron to analyse the economics behind AMR. This followed Cameron's July 2014 call for global action to address the growing threat posed by antibiotic resistance, on the back of discussions at the G7 summit. The G7 gathers leaders from seven major advanced economies, including Canada, France, Germany, Italy, Japan, the United Kingdom and the United States. As the economist who coined the acronym BRIC (Brazil, Russia, India and China), O'Neil is looking at ways to enhance international cooperation, including much closer involvement from low and middle income countries on the vital matter.
In the absence very few new antibiotics coming to the market over the past couple of decades, the review is also especially evaluating how to make antibiotics research & development (R&D) a more appealing investment to the pharmaceutical industry and other funding bodies. As part of the latest report published in May 2015, O'Neil estimated that up to USD 37 billion would be required in the next decade to motivate pharmaceutical manufacturers to move back into the R&D of innovative antibiotics due to the current dearth of market incentives. The majority of large manufacturers such as Pfizer, one of the pioneers of penicillin mass production, abandoned this field in the past 15 years mainly due to lack of profitability and onerous regulations.
The latest report, part of the O'Neil review, would grant priority funding of "lump sums of money" to manufacturers developing antibiotics active against bacteria where existing drugs are already the last line of defence. This would crucially reduce the risk of developing an innovative antibiotic and diminish the incentive to increase market share upon launch due to the disassociation of profitability to sales volume. The economist believes the industry might be persuaded to contribute while highlighting the need for a global AMR innovation fund of USD 2 billion during the next five year to inject into the basic research of new antibiotics.
Some manufacturers come back into antibiotic R&D
Amongst the few pharmaceutical giants still involved in antibiotic R&D, UK-based GlaxoSmithKline (GSK) welcomed the latest proposals by O'Neil aimed at altering the economic model to incentivise research in the field whilst maintaining reasonable returns. With a research unit focused on antibiotics, GSK is also part of a research program entitled NewDrugs4BadBugs co-funded by the Innovative Medicines Initiative (IMI) as well as other pharmaceutical and biotech firms. IMI is a research partnership between the European Commission and major pharmaceutical companies. In fact, GSK along with other manufacturers and the IMI have committed funds towards a public private consortium called DRIVE- AB that intends to develop and test new economic models of antibiotic R&D.
Fellow pharmaceutical firm Roche also wants to be part of the solution proposed by O'Neil that requires cross-stakeholder collaboration on a global scale. Under its latest move after a high-profile return to antibiotics research, Roche signed a USD 750 million license deal with Meiji Seika Pharma (Japan) and Fedora Pharmaceuticals (Canada) for the development and commercialisation- with the exception of Japan-of an early stage beta-lactamase inhibitor. The Phase I drug OP0595 is being evaluated in combination with existing beta-lactam antibiotics to combat Enterobacteriaceae induced infections, including multi-drug resistant strains.
The renewed interest in antibiotics was also marked in January 2015 by Merck's USD 9.5 billion acquisition of US antibiotic specialist Cubist Pharmaceuticals to complements its own growing presence in the arena. Besides pipeline targets, the deal allows access to Cubist's blockbuster antibiotic Cubicin (daptomycin for injection), the only approved once-a-day therapy for both Staphylococcus aureus bacteremia and complicated skin and skin structure infections and recently launched combination antibiotic Zerbaxa (ceftolozane/tazobactam) for the treatment of complicated urinary tract and intra-abdominal infections caused by Gram-negative bacteria.
Despite some big manufacturers bucking the trend, it is clear that more market incentives as part of an overhaul of the antibiotic R&D economic model need to be in place to attract the pharmaceutical industry back into actively investing in the currently meagre pipeline. UK pharmaceutical firm AstraZeneca announced in March 2015 that it is spinning-off its early stage antibiotics R&D to focus on three main therapy areas: cardio-metabolic diseases, oncology as well as respiratory and inflammation. This followed a previous announcement of reducing investment into this field. Although the latest report by the O'Neil review proposes incentives, big question marks remain about which criteria will allow new antibiotics to gain access to the global fund and who actually will finance it. It remains to be seen if this review will actually recommend a tangible set of actions that will receive international consensus in order to deal with the challenge of AMR.
Tania Rodrigues is a senior life sciences research analyst for IHS
Published 15 June 2015
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