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Insights into early stage of antibiotic development in small- and medium-sized
enterprises: a survey of targets, costs, and durations
#MMPMID29632669
Årdal C
; Baraldi E
; Theuretzbacher U
; Outterson K
; Plahte J
; Ciabuschi F
; Røttingen JA
J Pharm Policy Pract
2018[]; 11
(?): 8
PMID29632669
show ga
BACKGROUND: Antibiotic innovation has dwindled to dangerously low levels in the
past 30 years. Since resistance continues to evolve, this innovation deficit can
have perilous consequences on patients. A number of new incentives have been
suggested to stimulate greater antibacterial drug innovation. To design effective
solutions, a greater understanding is needed of actual antibiotic discovery and
development costs and timelines. Small and medium-sized enterprises (SMEs)
undertake most discovery and early phase development for antibiotics and other
drugs. This paper attempts to gather a better understanding of SMEs' targets,
costs, and durations related to discovery and early phase development of
antibacterial therapies. METHODS: DRIVE-AB, a project focused on developing new
economic incentives to stimulate antibacterial innovation, held a European
stakeholder meeting in February 2015. All SMEs invited to this meeting (n?=?44)
were subsequently sent a survey to gather more data regarding their areas of
activity, completed and expected development costs and timelines, and business
models. RESULTS: Twenty-five companies responded to the survey. Respondents were
primarily small companies each focusing on developing 1 to 3 new antibiotics,
focused on pathogens of public health importance. Most have not yet completed any
clinical trials. They have reported ranges of discovery and development
out-of-pocket costs that appear to be less expensive than other studies of
general pharmaceutical research and development (R&D) costs. The duration ranges
reported for completing each phase of R&D are highly variable when compared to
previously published general pharmaceutical innovation average durations.
However, our sample population is small and may not be fully representative of
all relevant antibiotic SMEs. CONCLUSIONS: The data collected by this study
provide important insights and estimates about R&D in European SMEs focusing on
antibiotics, which can be combined with other data to design incentives to
stimulate antibacterial innovation. The variation implies that costs and
durations are difficult to generalize due to the unique characteristics of each
antibiotic project and depend on individual business strategies and
circumstances.
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