Report: Approval success rates higher for smaller firms

The top 10 pharmaceutical companies out of the world's top 50 have lower estimated overall clinical approval success rates than do smaller firms in that group, according to a report completed by the Tufts Center for the Study of Drug Development. However, the top drugmakers also appeared to have some R&D productivity advantages. The study was based on 1,734 compounds that entered clinical testing between 1993 and 2004 for the top 50 companies, which had 2006 revenues of more than $1 billion.

According to the study, the top 10 firms also tended to end their trials of unsuccessful candidates during the early stages testing--something that "can help improve productivity of their new product pipelines," as Tufts CSDD director of economic analysis Joseph DiMasi, who conducted the study, points out.
The study, which appears in the September/October Tufts CSDD Impact Report, also found that small molecules accounted for 85 percent of the drugs that entered the clinical pipelines during this time period. In addition, large molecule clinical approval success rates outpaced small molecules by nearly 2:1 for each top-50 pharma size group examined. Finally, transitioning compounds from Phase II to Phase III posed a great challenge for all the companies surveyed.
 - see the Tufts release