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Jan 26, 2012

Navidea Gains Option to Alseres’ Parkinson Disease Imaging Agent

  • Navidea Biopharmaceuticals paid $500,000 to enter into an option agreement with Alseres Pharmaceuticals to license its imaging agent for Parkinson disease and other movement disorders. The deal gives Navidea six months to license the [123I]-E-IAFCT injection called Altropane®, an iodine-123 radiolabeled imaging agent.

    “Should we exercise the option, [123I]-E-IAFCT would provide us not only with another strong Phase III diagnostic imaging asset, but also one that has great synergy with our AZD4694 PET imaging agent, which we are developing as an aid in the diagnosis of Alzheimer disease. Together, we believe these programs provide us with a robust franchise in precision neuro-imaging diagnostics,” said Thomas Tulip, Ph.D., evp and chief business officer of Navidea.

    Navidea can extend the option period from June 30, 2012, to July 31, 2012, for an additional $250,000. The option agreement anticipates that Navidea will issue Alseres 400,000 shares of Navidea common stock upon execution of the definitive license agreement. The option also anticipates that the license agreement will provide for contingent milestone payments of up to $3.0 million, $2.75 million of which will principally occur at the time of product registration or upon commercial sales, and the issuance of up to an additional 1.05 million shares of Navidea stock, 950,000 shares of which are issuable at the time of product registration or upon commercial sales. In addition, the license terms outlined in the option agreement anticipate royalties on net sales.

    [123I]-E-IACFT 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 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 disease, the firms note.

    [123I]-E-IACFT has reportedly been administered to over 600 subjects to date. A Phase III SPA for [123I]-E-IACFT is already in place, and over 50 subjects have been enrolled to establish a training database. Results from clinical trials have demonstrated that [123I]-E-IACFT has high affinity for DAT and rapid kinetics, which enable the generation of clean images quickly—beginning within about 20 minutes after injection—while other agents typically have waiting periods from 4 to 24 hours before imaging can occur. In addition to its potential use as an aid in the differential diagnosis of Parkinson disease and movement disorders, [123I]-E-IACFT may also be useful in the diagnosis of dementia with lewy bodies.


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