The sponsor is a North America pharmaceutical company dedicated to the treatment of rare diseases. At the heart of the company’s work is the principle that people suffering from orphan diseases should have affordable and accessible medicines available to them.
The sponsor’s product was approved in Canada and it wanted to make it available to patients in Europe. However, the sponsor had little experience outside the Canadian health system and did not possess adequate knowledge of the European market to manage this in-house. To further complicate the matter, a competitor already had an approved product being used to treat patients in Europe. As such, the company did not know if there was even an opportunity for its product.