ABSTRACT
The obverse of me-too status is novelty. Data published by IMS in 2012 on trends in the number of US drug approvals over the period 200211 showed an increase in the number of drugs with new mechanisms of action. A new mechanism of action for a product does not necessarily indicate high commercial potential. Orphan drugs are by definition for small populations of patients. The majority of sales of another blockbuster, Rituxan/MabThera, have been generated in two orphan indications, chronic lymphatic leukaemia and non-Hodgkin's lymphoma. Irena Melnikova, director of strategies and external innovation at Sanofi US, found that in the 1990s 17 per cent of all drugs approved in the United States were orphans. Orphan drugs therefore form a significant though modest proportion of all products and are not much more dominant now than they were in 2007.
