Licensing

Figure 5: Licensing

For decades, a key element of the business development strategy of pharmaceutical companies has been the licensing of compounds in clinical development or compound candidates, starting from the non-clinical phases, up to the market release. The license from a Regulatory Authority is necessary to get the product legally to the market and the Health Technology Assessment (HTA) process to get the price. Due to the limited number of compound candidates that reach the later stages of development and their increasing costs, there has been a trend towards earlier licensing deals. This includes deals for promising ‘non-clinical’ candidates, i.e. compound candidates that have not yet been tested in humans but that are performing well in early studies.