In a new study, Tufts Center for the Study of Drug Development reports that approval rates for smaller pharma companies among the TOP 50 were higher than those for the TOP 10. This is perhaps counter intuitive.
The study was based on 1734 compounds that entered clinical testing between 1993-2004. The following points came out of the study:
- Success rates were 30% higher for 30 smallest firms compared to the top 10
- Small molecules accounted for 85% of drugs that entered pipeline in period
- CNS was the therapeutic class with highest share of investigational drugs
- Top 10 firms terminated a higher share of their failures in Phase I
- Large molecule approval rates outpaced small molecules 2:1
- The Phase II to Phase III transition was biggest hurdle for all firms
Another conclusion? By failing more products in Phase I, Top 10 companies can improve productivity (return) of their pipelines by not wasting more money on late failures. This supports the "fail fast" mantra. The data also supports contention that large molecules will contribute a greater percentage of future industry revenues. Also, there is support that more Phase III failures are occuring -perhaps due to the more difficult therapeutic areas being attacked - CNS, oncology, etc.
Posted by Bruce Lehr September 10th 2010.