Digging for new solutions

Abstract

The magnitude of the increasing problem of resistance really takes all its meaning when appraised side-by-side with the paucity of new antimicrobials reaching the market (1). Several factors have contributed to making antimicrobial discovery less fashionable nowadays. The gigantic costs of bringing a new compound to market, from the identification of a promising target at the preclinical stages, to the final clinical trials and approval, are clearly a strong deterrent. This emphasizes the difficulty in realizing an interesting financial return, given that antimicrobials are used for diseases occurring on a very short timespan (compared with the treatment of chronic conditions) and that regulatory requirements are strict (2). In the United States, in an attempt to stimulate the discovery of new antimicrobials, the Generating Antibiotic Incentives Now (GAIN) Act has been passed by the Obama administration. Among the provisions of the Act, sponsors developing new antibiotics may benefit from the following incentives: five additional years of market exclusivity, priority review, fast-track approval and updated guidance (3). The impact of the GAIN Act is difficult to evaluate such a short time after its implementation, but considering the high costs of development and evaluation, five additional years of market exclusivity appears to be a small upgrade to really provide incentive to pharmaceutical companies to invest in this field.