Table 7.
Success rates and costs for development of an anti-malarial medicine (2007–12), compared with benchmark data from the Centres for Medicines Research (2008–11)
| Stage | Cumulative success rates (CMR) | Cumulative success rates (MMV) | Cost per stage (MMV)b / millions USD |
|---|---|---|---|
| Preclinical |
4.4% |
12% |
1.8 |
| Phase I |
8% |
23% |
1.5 |
| Phase IIa |
15% |
34% |
5.4 |
| Drug interactions/ Phase IIb |
51%a |
60% |
8.7 |
| Phase III |
68% |
80% |
31.0c |
| Submission | 96% | 100% | 2.0 |
Notes:
aA stage success rate of 75% for combining two medicines has been added in to reflect the potential for unfavourable drug-drug interactions that prevent further development of a combination. The same correction has been used for CMR and MMV success rates, although our experience of these studies is currently not sufficiently large to enable this to be accurately estimated.
bThe cost per phase is based on MMV project costs, and does not allow for in-kind contributions from our pharmaceutical partners, or for the internal MMV staff costs.
cThe estimate for phase III costs is taken from the pyronaridine-artesunate project, where all the clinical costs were borne by MMV, and four pivotal studies were carried out. This does not include internal project management costs.