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Beta-amyloid imaging agent production to expand in U.S.

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August 21, 2013 - Siemens’ PETNET Solutions signed an agreement with Navidea Biopharmaceuticals granting Siemens’ PETNET Solutions the right to manufacture Navidea’s Fluorine-18 labeled NAV4694, which is currently being assessed in Phase II and Phase III clinical trials as a beta-amyloid PET imaging agent.

Beta-amyloid plaque is one of the necessary pathological features of Alzheimer’s disease—the sixth leading cause of death in the United States. PET amyloid scans can help visualize beta-amyloid plaque in the living brain. 

Sagittal and axial views of positron emission tomographic (PET) scans of representative patients. Clark CM, Schneider JA, Bedell BJ, et al. Use of Florbetapir-PET for Imaging β-Amyloid Pathology. JAMA. 2011;305:3.

Under the terms of its agreement with Navidea, Siemens’ PETNET Solutions will initially manufacture NAV4694 at select U.S. radiopharmacies, with the possibility of expanding into additional PETNET Solutions locations next year.

“This agreement with Navidea reaffirms the commitment of Siemens’ PETNET Solutions to driving innovation in PET imaging by supporting the availability of new PET imaging agents with our manufacturing expertise and increasing patient access to new PET examinations,” said Dr. Christoph Zindel, CEO of Siemens’ PETNET Solutions, “and by manufacturing investi-gational PET imaging agents for clinical trials.”

 “Navidea is committed to providing the medical community with valuable precision diagnostics like NAV4694, which is currently being assessed in Phase II and III clinical trials evaluating subjects with signs or symptoms of cognitive impairment such as Mild Cognitive Impairment and Alzheimer’s disease to improve diagnostic accuracy, clinical decision-making and ultimately patient care,” said Dr. Mark Pykett, CEO of Navidea. “We are pleased the NAV4694 clinical program will be supported by PETNET Solutions extensive manufacturing and dispensing expertise.”

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August 21, 2013

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