Updated: 6/7/2017 at 4:08 PM EST.
Experts agree that there is a need for a steady stream of innovation to address the constantly increasing rate of antimicrobial resistance. In a session entitled, “Bridging the ‘Valley of Death,’” the speakers described the gaps in antimicrobial development and discussed how government and private industry are working to address these gaps in antimicrobial drug development.
Joseph Larsen, PhD, Director of Biomedical Advanced Research and Development Authority (BARDA) with the US Department of Health and Human Services, described how BARDA is working to help pharmaceutical companies develop new drugs for emerging infectious diseases. The general focus is on chemical, biological, radiological and nuclear defense, where antibacterial development is one of the key areas of focus. The pace of antimicrobial drug development has not kept up with the rate at which resistance is developing. So, BARDA has been providing incentives for development and marketing.
Dr. Larsen pointed out that the current antibiotic drug development model takes many years to bring to market, and profit is only achieved after an average of 23 years. This kind of failure to market the drugs has led to significant innovation gaps for addressing antimicrobial resistance. Moreover, for the last 6 antibiotics approved in the United States, the projected first 2 years’ sales ranged between $30 million to $80 million, which is not much when compared to medications used to treat more chronic diseases, which routinely have first 2 year sales in excess of a billion dollars. So, investors are choosing to focus their efforts on developing drugs for chronic diseases.
Moreover, Dr. Larsen pointed out that there has not been a new class of drugs for treating gram-negative bacilli for over 5 decades. There are between 40 and 50 candidate antibiotic drugs in phase 3/4 studies, as compared to over 500 for oncology. Smaller biotech companies are doing most of this research, while larger companies have generally left this area of research and development (R & D). The first few years in the market, no one really knows how often these drugs will be used. Moreover, the vast majority of infections are treatable with broad-spectrum antibiotics.
To address the uncertainties that drug developers face, push and pull incentives have been offered by BARDA. Push incentives include providing direct support for developers as grants or contracts. Pull incentives include incentives to private investors that create visible market demand or rewards for milestone successes. Examples include milestone payments and regulatory incentives. Currently, there is a lack in substantial pull incentives.