The sponsor is a global pharmaceutical company focused on developing and commercializing generic and specialty medicines. Its goal is to help patients around the world live healthier lives in a way that is responsible and sustainable across all the communities it serves.
To satisfy an influx of unsolicited patient requests from Ex-US countries, the sponsor wanted to make its FDA approved product available to patients in countries where it is not licensed, especially those countries in which they do not intend to seek approval. The sponsor understood that some patients in lower income countries might find it difficult to pay the US price of the drug.
They, therefore, needed a solution that would allow all patients equal access.