Navidea Biopharmaceuticals Licenses Parkinson's Imaging Agent

August 7, 2012 — Navidea Biopharmaceuticals Inc., a company focused on precision diagnostic radiopharmaceuticals, announced it has entered into an agreement with Alseres Pharmaceuticals Inc. to license [¹²³I]-E-IACFT Injection (CFT), an iodine-123 radio-labeled imaging agent being developed as an aid in the diagnosis of Parkinson’s disease and other movement disorders, with a potential use as a diagnostic aid in dementia.

CFT is a patented, novel, small molecule radiopharmaceutical used with single photon emission computed tomography (SPECT) imaging to identify the status of specific regions in the brains of patients suspected of having Parkinson’s disease. The agent binds to the dopamine transporter (DAT) on the cell surface of dopaminergic neurons in the striatum and substantia nigra regions of the brain. Loss of these neurons is a widely recognized hallmark of Parkinson’s disease.

CFT has been administered to more than 600 subjects in multiphase clinical trials to date. Results from these clinical trials have demonstrated that CFT has high affinity for DAT and rapid kinetics that enable the generation of clean diagnostic images quickly, beginning within approximately 20 minutes after injection. In addition to its potential use as an aid in the differential diagnosis of Parkinson’s disease and movement disorders, CFT may also be useful in the diagnosis of dementia with Lewy bodies (DLB), which, after Alzheimer’s disease, is one of the most common forms of dementia.

“The diagnostic dilemma in movement disorders remains a pressing medical need that will continue to escalate as our world’s population ages,” said Mark Pykett, president and CEO of Navidea. “The addition of the CFT program is consistent with our growth strategy to build our precision radiopharmaceutical pipeline with later-stage, high-value diagnostics aimed at important medical needs.”

“We believe that CFT has the potential to be a best-in-class imaging agent to improve diagnostic accuracy by differentiating Parkinson’s disease from non-degenerative movement disorders, especially during the period soon after symptom-onset,” said Thomas Tulip, executive vice president and chief business officer at Navidea. “This licensing agreement has afforded Navidea another strong Phase 3 diagnostic imaging asset that has great synergy with our AZD4694 imaging program, which we are developing as an aid in the diagnosis of Alzheimer’s disease. These exciting programs provide us with a robust franchise in precision neuroimaging diagnostics.”

Under the terms of the license agreement, Alseres granted Navidea an exclusive, worldwide sub-license to research, develop and commercialize CFT. The final terms of the agreement call for Navidea to make a one-time sub-license execution payment to Alseres equal to $175,000 and issue Alseres 300,000 shares of NAVB common stock.

For more information: www.navidea.com