The threat of antimicrobial resistance is spreading and with it the urgency to find solutions to the matter. This week, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) provided its recommendations on how to slow down antimicrobial resistance and boost antibiotic research and development. In addition, the association organised a forum on the subject today.
After what has been considered by many as a disaffection for research and development of new antibiotics by the pharmaceutical sector, IFPMA’s report [pdf] “Rethinking the way we fight bacteria,” suggests a number of recommendations for a new economic model to incentivise innovation, and ensure access to antibiotics.
The number of antibiotics becoming obsolete due to resistance is greater than the number of new products being approved, said the industry group. In 2014, two new antibiotics against tuberculosis were approved after more than three decades of “discovery void.”
Yesterday, the World Health Organization released a report providing a global situation analysis to the national response to antimicrobial resistance. The upcoming World Health Assembly (18-26 May) is expected to consider for approval a draft global action plan on antimicrobial resistance (IPW, WHO, 29 April 2015). The draft WHO action plan would boost awareness of antimicrobial resistance, optimise the use of antibiotics and seek to ensure sustainable investment in the field. The plan calls for antibiotics to be considered as a public good and insists on equitable and affordable access to new medicines.
According to the IFPMA, appropriate use of antibiotics is part of the solution to antimicrobial resistance, as well as increased immunisation levels.
Why So Few New Antibiotics
There is also a dire need for new products but antibiotics generally provide a low return on investment, according to the industry, in particular because of the limited use of new therapies kept in reserve as medicines of last resort, and the relatively short period for which antibiotics are taken compared with drugs for chronic diseases.
Antibiotics development costs are high, and clinical trials on new antibiotics are difficult to carry out, the report said, “because placebo-controlled trials for serious bacterial infections are unethical” and scientists need to use a “more challenging” design for trials of new antibiotics.
Industry Seeks New Economic Model
IFPMA called for a new economic model that includes both push and pull mechanisms. In the push mechanisms, the report includes public-private partnerships and tax credits. In the pull mechanisms it lists prizes; extended date exclusivity, and advance market commitments. It also mentions priority review vouchers, which “reward a manufacturer that developed a new medicine for neglected diseases with a voucher that could be redeemed for priority review of a future medicine, probably a potential blockbuster drug.”
Premium prices and delinking revenue from usage should also be part of new economic models, the industry group said. Delinking revenue from usage delinks the volume of sales from the reward paid for a new antibiotic, it said.
The IFPMA report offers seven recommendations for a new economic model to incentivise innovation, meet preservation goals and ensure access to antibiotics, in particular, providing attractive and predicable prospects of return on investment, rewarding risk-taking for small and large companies, and envisaging antibiotics R&D “as a system by incentivizing both the bringing of a new medicine to registration and continued development.” The report also recommends that access to all patients with infections resistant to other antibiotics be facilitated.
Some 34 antibacterial compounds are currently under development in 11 IFPMA members, according to the IFPMA.
Geneva Pharma Forum
Separately, today, IFPMA organised a “Geneva Pharma Forum” convening several speakers to address antimicrobial resistance.
Stephan Harbarth, Infection Control Programme at the Geneva University Hospitals, said multi-resistant bacteria increase morbidity and mortality, pushes physicians to use more toxic, less efficacious, and more expansive alternatives, and raises direct and indirect costs.
He also remarked that the effects of antimicrobial resistance are likely to be more acute in lower income countries.
Marco Cavaleri, head of the Anti-infectives and Vaccines, Scientific and Regulatory management Department at the European Medicines Agency, described the efforts of the EMA and its European Union and international partners to tackle the issue of antimicrobial resistance. In particular, he said core guidance of the EU regulatory standards for approval of new antibiotics has been revised.
He also said some harmonisation efforts are ongoing, such as the Trans-Atlantic Task Force on Antimicrobial Resistance (TATFAR).
Cavaleri said the EMA is working on alternative therapies to antibiotics, such as bacteriophages, which are viruses used to kill bacteria. However, some regulatory issues related to manufacturing and clinical studies for these products need to be solved.
For John Rex, senior vice president and head of infection, global medicines development, AstraZeneca Pharmaceuticals, the problem of economics is key in addressing the issue of antimicrobial resistance.
One of the issues is the cost of development of a new antibiotic. He said it is estimated that over a period of 13 years, about US$ 600 million needs to be spent with an approximate total sales over the next 20 years of US$ 2.5 billion. However, he said, factoring for “net present value”, which applies a discounted rate of 10 percent per year, means that over those 33 years, the development of such product will produce a loss of US$ 50 million.
Source: Intellectual Property Watch