On October 18, 2021 Immunocore (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, and Medison Pharma Ltd., a global pharma company focused on providing access to highly innovative therapies to patients in international markets, reported an exclusive multi-regional agreement for Medison to help seek regulatory authorization and commercialize Immunocore’s tebentafusp (IMCgp100), for the treatment of patients with metastatic uveal melanoma, in Canada, twenty markets across Central Eastern Europe and Israel (Press release, Immunocore, OCT 18, 2021, View Source [SID1234591447]).
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"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," said Ralph Torbay, Head of Commercial at Immunocore.
"We are delighted to partner with Immunocore in 22 markets to accelerate the global reach of this breakthrough treatment for metastatic uveal melanoma", said Meir Jakobsohn, Founder and CEO of Medison Pharma. "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 been granted Priority Review; Real Time Oncology Review; Breakthrough Therapy designation; Fast Track designation; and orphan drug designation by the U.S. Food and Drug Administration (FDA) in the United States; orphan drug status in the European Union; and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. Tebentafusp has also been granted accelerated assessment by the European Medicine Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP). Immunocore’s biologics license application for approval of tebentafusp for the treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma was recently accepted by the FDA. In addition, EMA’s CHMP has accepted Immunocore’s Marketing Authorisation Application.