Report Advises Multi-Pronged Strategy to Fuel New Antibiotics Development

A UK-funded report is calling for drugmakers and regulators to set a goal of creating 15 new antibiotics every 10 years, at least four of which would be breakthrough products, to fight the rise in antibiotic resistant bacteria.

Companies that develop new therapies addressing the greatest unmet need would be awarded lump-sum payments of between $1 billion and $1.3 billion, regardless of how many units sell. This guarantees return on investment, even when weaker sales figures would not justify the money spent on development, the report says.

Governments would also be encouraged to partner with industry and shell out milestone payments at certain points in the development process.

According to Securing New Drugs for Future Generations: The Pipeline of Antibiotics, the greatest need is in narrow-spectrum antibiotics that work against Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter cloacae and E. coli.

Alternatively, the report suggests a global coalition to purchase the sales rights to new antibiotics. In this case, a developer would surrender marketing rights for the finished product, but the coalition would compensate them sufficiently to ensure an adequate return on development costs and perhaps a profit.

The market prices of these products should be determined by specific criteria that would allow an independent panel to assess the unmet need a drug fulfills and its level of efficacy, the report says. A follow-on antibiotic that doesn’t offer any significant benefit over an existing drug would get a lower score than, for example, a first-in-class product — unless it manages to reduce toxicity or circumvent established patterns of resistance.

The report also suggests that regulatory agencies work together to allow companies to license their products in many places at the same time — using the European Union’s rapporteur system as a model.

Further, governments should create a dedicated antimicrobial resistance innovation fund of some $2 billion over five years to fill in gaps in traditional research funding, the report says. The funds could go to revisiting libraries of antibiotics to find ways of combining them with other compounds that might break resistance. Though this wouldn’t be commercial enough to attract industry, it could help make existing drugs last longer, giving researchers time to develop new ones, the report adds.

The report was authored by Jim O’Neil, retiring chairman of assets management at Goldman Sachs. Read it at www.fdanews.com/03-18-15-UKantibioticreport.pdf. — Lena Freund