cancer, infection, and autoimmune disease, and Medison Pharma Ltd., which is a global pharmaceutical business aimed at increasing patient access to highly advanced treatments in international markets, have entered into an exclusive multi-regional agreement for Medison to help gain regulatory approval and market Immunocore’s tebentafusp to treat metastatic uveal melanoma patients in Canada as well as twenty markets throughout Central Eastern Europe and Israel.
Ralph Torbay, Head of Commercial at Immunocore, expressed delight over the collaboration with Medison. He said, “Following the acceptances of the Biologics License Application and Marketing Authorization Application for tebentafusp in metastatic uveal melanoma by regulatory agencies in the U.S. and Europe, we are excited to partner with Medison Pharma to increase our potential ability to reach patients with metastatic uveal melanoma in many more countries”.
Meir Jakobsohn, Founder and CEO of Medison Pharma, expressed optimism about partnering with Immunocore and stated that they are aiming to reach international markets through this collaboration. He said, “We are delighted to partner with Immunocore in 22 markets to accelerate the global reach of this breakthrough treatment for metastatic uveal melanoma. In our joint commitment to help treat patients suffering from the most challenging diseases, we look forward to leveraging our commercial platform and providing patients in international markets with access to this much needed therapy.”
Tebentafusp has received the following statuses. It has been given Priority Review, Real-Time Oncology Review, Breakthrough Therapy status, Fast Track designation, and orphan drug designation by the United States Food and Drug Administration (FDA). It has also received orphan drug status in the European Union and Promising Innovative Medicine (PIM) status under the United Kingdom’s Early Access to Medicines Scheme for metastatic uveal melanoma.
Additionally, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave tebentafusp an expedited evaluation. The FDA has accepted Immunocore’s biologics license application for tebentafusp for the treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma. Furthermore, Immunocore’s Marketing Authorisation Application has also been approved by the EMA’s CHMP.
