Helping a Company Introduce and Commercialise its Health Canada Approved Product in the European Market
Genetic metabolic disorder
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.
The sponsor decided to partner with WEP Clinical to take advantage of our expertise and experience introducing new products into the Europe market. Our first step was to make this product available to patients through a Named Patient Program, which supplied the drug on an unlicensed basis to requesting physicians who were unable to treat their patients with the competitor product. This allowed us to develop an understanding of the clinical need, competitive landscape and potential opportunity for the product among the patient population. Concurrently, we supported the sponsor through the EMA approval process and developed a market access strategy for post-approval and commercialization efforts. Our on-the-ground Country Managers in key European territories, helped raise awareness of the product throughout this process, and facilitated the reimbursement and filing activities with local health agencies in each country. WEP Clinical is now the exclusive commercial sales partner for this product across several EU countries.
The program has been running for over 4.5 years
3255 units of drug have been shipped
48 hospitals currently in scope
Patients in 12 countries across Europe