Alseres, Navidea team up for Parkinson’s diagnostic agent

Agreement to cover research, development and commercialization of imaging agent

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HOPKINTON, Mass.—Alseres Pharmaceuticals, Inc. has announcedthe signing of an agreement with Navidea Biopharmaceuticals, Inc. to licenseAltropane ([123I]-E-IACFT Injection (CFT)). The drug is an Iodine-123radiolabeled imaging agent and is currently being developed to aid in thediagnosis of Parkinson's disease and movement disorders.
"We are pleased to have completed this agreement withNavidea," Peter G. Savas, CEO of Alseres, said in a press release. "With itsfocus, dedication and imaging expertise, Navidea represents an ideal partner tocomplete the development and commercialization of this promising agent that mayhelp millions of patients with movement disorders arrive at a more timely andaccurate diagnosis."
The companies' cooperation on the drug began in January,when they executed an option agreement under which Navidea paid Alseres$500,000 in exchange for the exclusive option to license the program, conductits due diligence review of the program and prepare the paperwork for executingthe license. Per the terms of the agreement, Navidea has received an exclusive,worldwide sublicense to research, develop and commercialize CFT, and for itspart, will make a one-time sublicense execution payment to Alseres of $175,000and issue 300,000 share of NAVB common stock to Alseres as well. In addition,the agreement also covers contingent milestone payments of up to $2.9 million,of which $2.5 million will occur upon product registration or commercial sales,as well as the issuance of up to another 1.15 million shares of Navidea's stock(950,000 of which are issuable at the time of product registration or commercialsales). The license also covers the distribution of royalties.
"The diagnostic dilemma in movement disorders remains apressing medical need that will continue to escalate as our world's populationages," Dr. Mark Pykett, president and CEO of Navidea, said in a pressrelease. "The addition of the CFT program is consistent with our growthstrategy to build our precision radiopharmaceutical pipeline with later-stage,high-value diagnostics aimed at important medical needs."
CFT is a novel, small-molecule radiopharmaceutical used withsingle photon emission computed tomography imaging in order to determine thestatus of certain regions in the brains of suspected Parkinson's diseasepatients. The drug binds to the dopamine transporter (DAT) on the cell surfaceof dopaminergic neurons in two different regions of the brains, as the loss ofthose neurons is a well-known characteristic of the disease. CFT has beentested in more than 600 subjects in multi-phase clinical trials, and has shownto have a high affinity to DAT, in addition to allowing for the rapidgeneration of clean diagnostic images. Beyond its use in diagnosing Parkinson'sdisease and movement disorders, CFT also stands to have application potentialin diagnosing dementia with Lewy Bodies, which ranks as one of the most commonforms of dementia after Alzheimer's disease.
"We believe that CFT has the potential to be abest-in-class imaging agent to improve diagnostic accuracy by differentiatingParkinson's disease from non-degenerative movement disorders, especially duringthe period soon after onset of symptoms," Dr. Thomas Tulip, executive vicepresident and chief business officer at Navidea, said in a press release.
SOURCE: Alseres Pharmaceuticals press release

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