Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) today announced that it has completed an agreement to sub-license its Onalta™ brand 90-Y edotreotide radiotherapeutic in certain countries in Europe, the Middle East, North Africa, Russia and Turkey to BioMedica Life Sciences, S.A., Athens, Greece.
Onalta is a novel radiotherapeutic product candidate under development for the treatment of metastatic carcinoid and pancreatic neuroendocrine tumors in patients whose symptoms are not controlled by conventional therapy. The compound has shown the potential to selectively deliver lethal radiation to cancer cells. Onalta has received Orphan Drug Designation in the EU and the European Medicines Agency (EMEA) has accepted Molecular Insight's Phase 3 protocol design and plan for EU development. Molecular Insight licensed the rights to edotreotide (the parent compound of Onalta) from Novartis Pharma AG.
At present, there continues to be a worldwide need for effective treatments for metastatic neuroendocrine tumors. An unapproved version of 90-Y edotreotide is currently used in some European countries as a compassionate use therapy.
The agreement provides BioMedica an exclusive sub-license to intellectual property rights and know-how of Molecular Insight and Novartis with respect to Onalta. Under the agreement, BioMedica is expected to perform clinical studies and market, distribute and commercialize Onalta in the specified territories and secure all regulatory approvals. Under the terms of the agreement, BioMedica will purchase finished product, including compassionate use and clinical trial supplies exclusively from Molecular Insight for a five-year period, with a five-year renewal option. Molecular Insight continues to retain all rights to all other markets and territories, including the United States, Japan and Asia.
Under terms of the agreement, Molecular Insight will receive an initial, nonrefundable payment of $4.4 million and will be eligible to receive additional regulatory milestone payments. Overall, Molecular Insight could receive more than $10 million in total regulatory milestone and upfront payments, net of license payments. Molecular Insight also is eligible to receive milestone and tiered royalties on Onalta sales.