YARDLEY, Pa. & DUBLIN, Ohio--(BUSINESS WIRE)--Jubilant Radiopharma, a business unit of Jubilant Pharma Limited and Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) announced today that both companies have signed a binding memorandum of understanding (“MOU”). The MOU outlines the terms and framework for an Exclusive License and Distribution Agreement (“ELDA”) for Navidea’s diagnostic imaging agent Tilmanocept (technetium Tc 99m tilmanocept injection) in the United States, Canada, Mexico, and Latin America. In connection with the MOU, Jubilant Radiopharma also made a $1 million equity investment in exchange for a limited exclusivity period while final due diligence efforts are completed.

Tilmanocept, which is entering Phase 3 clinical trials for approval by the United States Food and Drug Administration (FDA), will enable Nuclear Medicine departments to visually and quantifiably localize and monitor activated macrophages in patients suspected of having rheumatoid arthritis (RA). RA is a painful long-term autoimmune disorder that primarily affects joints in the human body resulting in long term damage if left untreated. In the Unites States over 1.3 million Americans suffer from this disease.

“For many years oncologists, cardiologists, neurologists and many other medical specialties have benefited from the information nuclear medicine procedures provide them to guide the way they manage their patients,” commented Sergio Calvo, President Radiopharmaceuticals Division, Jubilant Radiopharma. “We are confident rheumatologists will also benefit from these procedures, creating an even greater demand for this valuable modality.”
“Jubilant Radiopharma business is focused on developing, manufacturing, commercializing and distributing diagnostic and therapeutic radiopharmaceuticals,” stated Pramod Yadav, CEO, Jubilant Pharma Limited. “Jubilant Radiopharma is committed to improving lives through Nuclear Medicine by providing healthcare professionals access to high quality, FDA approved products that enable better patient outcomes. We are pleased to partner with Navidea Biopharmaceuticals to create access to this important new diagnostic imaging agent.”

“Correct characterization of this debilitating disease and having the ability to monitor therapeutic response to drug therapies is of significant importance to patients,” said Dr. Michael Rosol, Chief Medical Officer at Navidea. “Visualizing disease processes at the cellular level will provide even greater information to health care providers, ensuring the appropriate therapy is administered at the appropriate time yielding better patient outcomes.”

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