Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced it has signed an agreement with Siemens’ PETNET Solutions that grants PETNET Solutions the right to manufacture Navidea’s Fluorine-18 labeled NAV4694, an investigational beta-amyloid PET imaging agent, which is currently being evaluated in Phase 2 and 3 clinical trials evaluating subjects with signs or symptoms of cognitive impairment such as Mild Cognitive Impairment and Alzheimer’s disease. Under the terms of its agreement with Navidea, Siemens’ PETNET Solutions will initially manufacture NAV4694 clinical trial material at select U.S. radiopharmacies, with the possibility of expanding into additional Siemens’ PETNET Solutions locations next year.
“We are delighted that the NAV4694 clinical program will be supported by Siemens’ PETNET Solutions’ extensive PET manufacturing and dispensing expertise,” said Mark Pykett, CEO of Navidea. “Navidea is committed to providing the medical community and patients afflicted by Alzheimer's disease, Parkinson’s disease and other neurodegenerative disorders with valuable precision diagnostics that ensure the best patient outcome including improved diagnostic accuracy, clinical decision-making and patient care.”
“Siemens' PETNET Solutions is proud to collaborate with Navidea, a leading biopharmaceutical company, to support the availability of new PET imaging agents with our manufacturing expertise as the largest PET radiopharmaceutical manufacturer in the world,” said Dr. Christoph Zindel, CEO of Siemens’ PETNET Solutions. “Our collaboration with Navidea reaffirms our commitment to help fight the world's most challenging diseases, including Alzheimer's disease.”
Siemens’ PETNET Solutions operates the world’s largest network of PET radiopharmaceutical drug manufacturing facilities and dispensing nuclear pharmacies, with over 50 locations worldwide. They manufacture and dispense PET radiopharmaceuticals for hospitals, clinics and research facilities worldwide.
NAV4694 is a Fluorine-18 labeled precision radiopharmaceutical candidate intended for use in Positron Emission Tomography (PET) imaging and evaluation of patients with signs or symptoms of cognitive impairment such as Alzheimer’s disease (AD). NAV4694 binds to beta-amyloid deposits in the brain that can then be imaged in scans. Beta-amyloid plaque pathology is widely used in the diagnosis of AD. The ability of NAV4694 imaging to display amyloid plaque pathology may enable earlier identification of AD and improve monitoring of disease progression and interpretation of brain scan images. Navidea has an ongoing NAV4694 Phase 2b trial in Mild Cognitive Impairment and a Phase 3 program for NAV4694 in AD.