Molecular Insight Executes Onalta Manufacturing, Supply Agreements

Molecular Insight Pharmaceuticals (Molecular Insight) has executed an exclusive 10-year agreement to supply the Onalta 90-Y edotreotide radiotherapeutic to BioMedica Life Sciences. 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.

Reportedly, in September, Molecular Insight entered into a Territory License Agreement with BioMedica for commercialisation of Onalta in certain European countries, the Middle East, North Africa, Russia and Turkey. Under the Agreement, BioMedica is expected to perform clinical studies and secure all regulatory approvals to market, sell and distribute Onalta within its licensed territories. Molecular Insight retains Onalta rights in all other markets and territories, including the US, Japan and Asia.

Molecular Insight has also entered into a contract manufacturing agreement with Eckert & Ziegler to manufacture and supply Onalta for compassionate use and registration clinical trials within the BioMedica territories.

Upon European Medicines Agency (EMEA) approval of a Market Authorisation Application, based on clinical studies, Eckert & Ziegler is expected to manufacture Onalta for commercial sales as well. The term of this agreement is for 10 years. The company said that the EMEA has reviewed and accepted Onalta’s phase 3 clinical trial protocol design and has granted Onalta Orphan Drug Designation.