NEW YORK, NY--(Feb 11, 2013) - Report is Available for Download at http://www.lifesciadvisors.com/clients/navidea/
LifeSci Advisors, LLC, a leading provider of investment research and investor relations services in the healthcare sector, today announced that it has initiated coverage of Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals. In 2011 and 2012, Navidea engaged in strategic business development activities and carved out a strategic niche effectively transforming itself into a pure-play precision diagnostics company with 4 late-stage products.
Navidea's lead product is Lymphoseek, which is a potential "First-in-Class" targeted imaging agent for lymphatic mapping. Following positive results from the two Phase 3 studies that hit on all endpoints, NEO3-05 and NEO3-09, Navidea filed the Lymphoseek NDA that was subsequently accepted by FDA. At the end of 2012, the Company filed a Lymphoseek MAA with the European EMA. In the US, Lymphoseek has an upcoming PDUFA goal date of April 30, 2013, and if accepted, Navidea and its marketing partner Cardinal Health, plan to launch with 80 direct sales representatives and an additional 400 technical liaisons, which should be sufficient to reach ~65% of direct customers and achieve 90-95% overall market penetration. We estimate Lymphoseek to have a global market potential of $643M.
"Effectively de-risking the Company's business model, Navidea has in-licensed two late-stage assets, NAV4694 and NAV5001, for the diagnosis Alzheimer's and Parkinson's disease, respectively," said Andrew I. McDonald, Ph.D., Managing Director at LifeSci Advisors. "NAV4694, which was licensed from AstraZeneca, is a Fluorine-18 labeled 'Best-in-Class' radiopharmaceutical candidate in development as an aid in the diagnosis of patients with Alzheimer's disease. NAV4694 binds to ß-amyloid deposits in the brain in order to help diagnose patients with Alzheimer's by way of PET imaging. NAV5001, licensed from Alseres, is a patented, novel, small molecule agent that binds to the dopamine transporter (DaT) on the cell surface of dopaminergic neurons and is a potential 'Best-in-Class' agent to be viewed via SPECT imaging to identify various regions in the brain associated with Parkinson's disease."
In a 38-page Initiation Report by LifeSci Advisors, the clinical, regulatory, and commercial aspects of Navidea's 4 late-stage diagnostic assets are discussed. NAV4694 has strong performance characteristics (rapid equilibrium, favorable CNS uptake, high signal-to-noise ratios, and low white matter background binding) and a very tight performance correlation to the benchmark amyloid imaging agent C-PiB. We expect Navidea to initiate the Phase 3 NAV4694 program in early 2013. We believe that NAV4694 may have a market potential of $1B or more. If successful, NAV4694 could generate similar interest from potential partners as Avid Radiopharmaceuticals' Amyvid, which was bought by Lilly for a potential $800M. Additionally, NAV5001 has demonstrated a high affinity for DaT and rapid kinetics, which should add to its ability to produce clean images quickly. To date, over 600 Parkinson's disease subjects have been treated with NAV5001 and a Phase 3 trial under an amended SPA should be initiated in the first half of 2013. We estimate that NAV5001 has a market potential of $1-1.5B.
Dr. McDonald's full Initiation Report is available to download at no cost at the LifeSci Advisors website, www.lifesciadvisors.com. In addition to this Initiation Report, LifeSci Advisors will also provide ongoing coverage and event-based research updates on the Company as developments occur.
The LifeSci Advisors research team is led by Dr. Andrew I. McDonald, an industry veteran with more than 15 years of healthcare industry experience. Prior to co-founding LSA, Dr. McDonald was the Senior Biotechnology Analyst at Great Point Partners, a leading health care investment firm with over $500 million under management. Before Great Point, he was Co-head of Healthcare Research and Lead Biotechnology Analyst at ThinkEquity Partners, a boutique investment banking firm focused on growth companies. Dr. McDonald holds a Ph.D. in organic chemistry from the University of California, Irvine, and, earlier in his career, worked as a medicinal chemist at both Pfizer and Cytokinetics.
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SOURCE: LifeSci Advisors