MIPI to sub-license the Onalta brand 90-Y edotreotide radiotherapeutic

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.

Molecular Insight President and Chief Executive Officer Daniel L. Peters said, "This agreement will advance an innovative therapy for inoperable neuroendocrine tumors into pivotal trials. This collaboration also is a first step in Molecular Insight's strategy to advance the Company's broad pipeline of five clinical candidates through collaborations with partners, as well as through the Company's own development efforts. This agreement is value creating for Molecular Insight and BioMedica in that it provides both companies near-term revenue generated from compassionate use in Europe and long-term value from revenues resulting from the approved product."

Yannis Vitsaras, BioMedica's Chairman and Chief Executive Officer, commented, "We view Onalta as an important addition to the treatment options available to patients throughout Europe who suffer at the hands of GEP-NET tumors (gastroenteropancreatic neuroendocrine). Our faith in this important targeted radiopharmaceutical stems from the promising data generated in preclinical and clinical studies. We are excited by this important opportunity for our company and look forward to working closely with our friends and colleagues at Molecular Insight Pharmaceuticals."