Covered Companies

Navidea (NAVB) Update 05-15-13

downloadreportNavidea & Cardinal Health Launch Lymphoseek® in U.S.
Strong Head & Neck Data Could Be Future Game Changer
European Lymphoseek Approval Possible by Year-End
NAV4694 Alzheimer’s & NAV5001 Parkinson’s to PIII

Download Full 36-Page Update Report with Important Disclosures: NAVB Update 05-15-13

Lymphoseek® Launched in U.S.: On May 1, 2013, Navidea launched their first product in the United States, Lymphoseek® (technetium 99m tilmanocept) Injection for patients with breast cancer and melanoma, partnered with Cardinal Health (NYSE:CAH) with a price of $300 per procedure. Investors should note that Cardinal is a very strong marketing partner with over 140 nuclear pharmacies and more than 400 radiopharmacists. As a result, they can reach 99% of the nuclear medicine customers within 3 hours after receiving an order. While Lymphoseek must use CMS A-Code A4641 Radiopharmaceutical, diagnostic, not otherwise classified, Navidea expects to file for a unique pass-through C-Code by the June 1st deadline for an October 1st implementation.

Lymphoseek Head & Neck Cancer Data could be a Game Changer: On April 11, 2013, Navidea announced that the interim data from their Phase III clinical trial of Lymphoseek met the primary endpoint in patients with head and neck squamous cell carcinoma. The interim results showed Lymphoseek accurately identified 38 of 39 cancer-positive lymph nodes for an overall False Negative Rate (FNR) of 2.56% which was statistically significant (p=0.0205). This is a particularly strong result as the goal was an FNR less than 10%. Lymphoseek only required the removal of 4 lymph nodes per patient on average versus an average of 38 lymph nodes per patient in the trial. LymphoSeek has the potential to provide a substantial reduction in lymph-related adverse side-effects for patients with head and neck cancer undergoing sentinel lymph node biopsy. These results were so strong that the Data Safety Monitoring Committee (DSMC) recommended the trial be ended early to speed an FDA filing. We now expect Navidea to use these strong results to make a solid case for expanding the label for Lymphoseek to a sentinel lymph node biopsy claim. Investors should note there are no FDA-approved imaging drugs for sentinel lymph node detection and if granted, Lymphoseek would represent a major game changer in the space.

European Partnership Soon: On December 18, 2012, Navidea announced they filed the European Marketing Authorization Application (MAA) for LymphoSeek® (technetium Tc 99m tilmanocept) injection for intraoperative lymphatic mapping (ILM) not restricted to any particular solid tumor type. The Day 120 EMA comments are due later this quarter and a positive CHMP opinion could come in Q4 2013. We then expect Navidea to announce a partner in Europe soon afterward. Partnerships could also be announced for other countries that accept FDA or EU marketing approvals such as Mexico, Israel, Singapore, Saudi Arabia and the Philippines.

NAV4694 for Alzheimer’s Disease Moving to Late-Stage Trials: Navidea is on track to initiate a late-stage Phase III registration trial for Dementia mid-year. On March 27, 2013, as an adjunct study to the Phase III Dementia trial, Navidea began enrollment of a Phase IIb trial for Mild Cognitive Impairment (MCI) for patients who have earlier stage cognitive impairment and would show utility for NAV4694 to diagnose dementia and cognitive impairment earlier. There is also an ongoing 200-patient Phase IIb, open-label, safety and efficacy study in subjects diagnosed with probable Alzheimer’s disease (AD) compared with similarly aged and young healthy volunteers. (see NAV4694 Alzheimer’s Clinical Trials)

NAV5001 Parkinson’s Disease Also Moving to Late Stage Trials: Navidea is also on track to begin pivotal Phase III studies in Parkinson’s disease (Movement Disorders) this year. On April 3, 2013, Navidea announced that Molecular Neuroimaging’s Investigator-Sponsored Trial (IST) enrolled the first subject in a clinical study to investigate the performance of NAV5001 in Dementia with Lewy Bodies (DLB). The IST is a single center, open-label study to assess the distribution, safety and tolerability of NAV5001 as an agent to evaluate the integrity of the dopamine transporters in the brain, using healthy volunteers. This study is in preparation for the planned company-sponsored Phase IIb study in Dementia with Lewy Bodies (DLB). NAV5001 has a high affinity that can generate clean images quickly, beginning 15 minutes after injection as opposed to waiting periods of 3-6 hours and up to 24 hours as required with other agents. NAV5001 is a fully synthetic molecule, unlike GE’s DaTscan, which is derived from cocoa leaves and regulated by the U.S. Drug Enforcement Agency (DEA). NAV5001 can also be sterilized whereas other agents are provided aseptically so NAV5001 could have important and practical convenience in handling advantages. (see NAV5001 Parkinson’s Imaging Background & Development Program)

Undervalued Shares Represent a Significant Investment Opportunity: We believe the current weakness in Navidea’s share price represents a limited view of Navidea’s true long-term value. With an FDA approval for their first product, LymphoSeek, under their belt and a U.S. launch by marketing partner Cardinal Health (NYSE: CAH) we believe management has proven themselves in getting to products into the market. Looking forward, investors can expect a European partnership announcement and EU approval by year-end as well as progress in expanding LymphoSeek’s label with head & neck data and colon cancer data in the future. In addition, Navidea continues to advancing two additional candidates, NAV4694 in Alzheimer’s disease and NAV5001 in Parkinson’s disease into late-stage Phase III trials during 2013 as well as getting RIGScan back into clinical trials with a humanized MAb. We believe these multiple shots-on-goal represent a significant buying opportunity as we reiterate our Strong Speculative Buy rating and 12-18 month price target of $5.75 based on a 35x multiple on projected fiscal year 2016 EPS and discounted 35% for cumulative risk.

Download Full 36-Page Update Report with Important Disclosures: NAVB Update 05-15-13

Navidea (NAVB) Note 05-01-13

downloadreportNavidea & Cardinal Health Launch Lymphoseek® in U.S.
First Lymph Node Mapping Drug in 30 Years for Breast & Melanoma
Lymphoseek® H&N Very Strong – DSMB Recommends Stopping Trial Early

Download Full 8-Page Note with Important Disclosures: Morning Note 05-01-13 NAVB

NOTE: Navidea will be holding a conference call today at 8:30am Eastern Time Dial-In: (877) 407-8031 International (201) 689-8031

Navidea announced the United States product launch of Lymphoseek® (technetium Tc 99m tilmanocept) Injection by their U.S. partner, Cardinal Health (NYSE:CAH). Cardinal will sell and distribute Lymphoseek to health care professionals through its existing network of nuclear pharmacies. Navidea will support the marketing and educational efforts as well.

Lymphoseek will initially be reimbursed under existing CPT (Current Procedural Terminology) codes priced at $300 per procedure. Navidea will be applying for a specific Lymphoseek CPT code and expects to receive it within few months. Navidea and Cardinal Health will provide information and support to providers and payers to ensure that they can secure formulary status and appropriate payment.

While Lymphoseek is approved for lymphatic mapping procedures for breast cancer and melanoma, we expect Navidea to file an sNDA (Supplemental New Drug Application) in Head & Neck cancer soon based on the NEO3-06 interim trial results. The results were so strong that the Data Safety Monitoring Board (DSMB) recommended stopping the trial early and filing.

Undervalued Shares Represent a Significant Investment Opportunity: We believe the current weakness in Navidea’s share price represents a limited view of Navidea’s true value. With an FDA approval for their first product, LymphoSeek, under their belt and an imminent U.S. launch by marketing partner Cardinal Health (NYSE: CAH) we believe management has proven themselves in getting past the previous PDUFA misses. Looking forward, investors can expect a European partnership announcement and EU approval by year-end as well as progress in expanding LymphoSeek’s label with head & neck data and colon cancer data in the future. In addition, Navidea is advancing two additional candidates, NAV4694 in Alzheimer’s disease and NAV5001 in Parkinson’s disease into late-stage Phase III trials as well as getting RIGScan back into clinical trials with a humanized MAb. We believe these multiple shots-on-goal represent a significant buying opportunity as we reiterate our Strong Speculative Buy rating.

Download Full 8-Page Note with Important Disclosures: Morning Note 05-01-13 NAVB

Navidea (NAVB) Note 04-24-13

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Navidea Investor J.P. Morgan Asset Management Adds More Shares

 

Download Full 7-Page Note with Important Disclosures: Morning Note 04-24-13 NAVB

Navidea announced the sale to J.P. Morgan Asset Management and one other institutional investor of 2,100,000 shares at $2.43 per share, representing an at-the-market price, for gross proceeds of approximately $5.1 million. This follows their January 30, 2013 sale to J.P. Morgan Asset Management and one other institutional investor of 1,542,389 shares of common stock at $3.10 per share for gross proceeds of approximately $4.8M.

Undervalued Shares Represent a Significant Investment Opportunity: We believe the current weakness in Navidea’s share price represents a limited view of Navidea’s true value. With an FDA approval for their first product, LymphoSeek, under their belt and an imminent U.S. launch by marketing partner Cardinal Health (NYSE: CAH) we believe management has proven themselves in getting past the previous PDUFA misses. Looking forward, investors can expect a European partnership announcement and EU approval by year-end as well as progress in expanding LymphoSeek’s label with head & neck data and colon cancer data in the future. In addition, Navidea is advancing two additional candidates, NAV4694 in Alzheimer’s disease and NAV5001 in Parkinson’s disease into late-stage Phase III trials as well as getting RIGScan back into clinical trials with a humanized MAb. We believe these multiple shots-on-goal represent a significant buying opportunity as we reiterate our Strong Speculative Buy rating.

Download Full 7-Page Note with Important Disclosures: Morning Note 04-24-13 NAVB

Navidea (NAVB) Note 04-19-13

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Peer-Reviewed Research: NAV4694 Favorable Versus Gold-Standard

 

Download Full 7-Page Note with Important Disclosures:Morning Note 04-19-13 NAVB

Data published online in the Journal of Nuclear Medicine in a paper titled “Head-to-Head Comparison of 11C-PiB and 18F-AZD4694 (NAV4694) for β-Amyloid Imaging in Aging and Dementia” from a clinical trial of Navidea’s NAV4694 versus the gold standard 11C-Pittsburgh compound-B (11C-PiB) in a head-to-head comparison in healthy and Alzheimer’s Disease patients demonstrated NAV4694 imaging characteristics were nearly identical to those of 11C-PiB. Investors should note that 11C-PiB only has a 20-minute radioactive decay half-life which limits its use to medical centers with an on-site cyclotron and 11C radiochemistry expertise. These factors result in making 11C-PiB PET too difficult and expensive for routine clinical Alzeimer’s Disease imaging. Previous attempts to use 18F-labeled amyloid tracers have shown more nonspecific white matter binding than 11C-PiB and some lower cortical binding in Alzheimer’s patients making visual interpretation of scans difficult in detecting low levels of cortical amyloid plaque and requiring significant training to interpret the scans in clinical practice. The researchers compared the cortical and white matter binding of 18F-AZD4694 (now Navidea’s NAV4694) 18F-labeled beta-amyloid tracer versus 11C-PiB in the same subjects. They found that Navidea’s NAV4694 showed “a robust separation between AD patients and healthy age-matched controls and less white matter binding than reported with other 18F-labeled amyloid tracers.” To further characterize NAV4694, the present study compared the cortical and white matter binding of 11C-PiB and NAV4694 in the same subjects. NAV4694 displayed imaging characteristics “nearly identical to those of 11C-PiB. The low white matter and high cortical binding in Alzheimer’s Disease indicate that this tracer is well suited to both clinical and research use.

The researchers concluded: “Our results demonstrate that 18F-AZD4694 is highly correlated with 11C-PiB and therefore should reliably detect Aβ deposition in the brain and be useful in the early and differential diagnosis of AD. 18F-AZD4694 provides images that appear similar to those of 11C-PiB, without the limitation of the short 11C radioactive decay half-life that precludes the application of 11C-PiB in clinical practice. The striking similarity with 11C-PiB suggests that the results from longitudinal studies that are clarifying the relationship between Aβ accumulation and cognitive decline, and asserting the value of Aβ imaging as a predictor of cognitive decline and progression to clinical AD, can be directly translated to 18F-AZD4694. The high cortical binding in AD and low nonspecific white matter binding also suggests that 18F-AZD4694 images may be more easily and reliably read in clinical practice than other 18F-labeled PET tracers for brain amyloid.

NAV4694vs11C-PIB

CLICK TO ENLARGE IMAGE

The paper may be accessed at http://jnm.snmjournals.org/content/early/2013/04/10/jnumed.112.114785.abstract 

Download Full 7-Page Note with Important Disclosures: Morning Note 04-19-13 NAVB

FluoroPharma (FPMI) Note 04-15-13

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FluoroPharma Strengthens Board with Imaging & FDA Regulatory Expertise

 

Download Full 7-Page Note with Important Disclosures: Morning Note 04-15-13 FPMI

FluoroPharma announced that Dr. Joseph A. Pierro has been appointed to the Board of Directors. Dr. Pierro is currently the Chief Medical Officer for North America at Biomedical Systems, where he is responsible for leading the Scientific Affairs groups, providing medical and regulatory guidance.

Dr. Joseph Pierro has over 25 years of imaging expertise in the field of radiology and more than 20 years of clinical trial research and development experience. In addition to Biomedical Systems, he has worked in such prestigious companies as Covidien (NYSE:COV), GE Healthcare (NYSE:GE) and Mallinckrodt and as a medical reviewer at the FDA Center for Drug Evaluation and Research. Dr. Pierro has been instrumental in numerous submissions to regulatory agencies offering substantial experience in scientific review and medical writing of clinical development strategy, clinical protocol development, and clinical study reports. In addition to imaging, Dr. Pierro provides broad expertise in safety, medical monitoring, pharmacokinetics, pharmacodynamics, biostatistics, and clinical safety reporting. He has a thorough understanding of regulatory submission requirements and an outstanding track record of success with regulatory approvals and responses to regulatory authorities. He has contributed to numerous scientific publications in peer reviewed journals and authored a manual of radiology. Dr. Pierro received his medical degree at the State University of New York at Buffalo School of Medicine and completed residency training in diagnostic radiology at Northeastern Ohio’s Integrated Residency program in Youngstown, Ohio.

We believe Dr. Pierro’s expertise in imaging, cardiology, clinical trial design and FDA experience will add significantly to FluroPharma’s progress in the cardiac PET imaging space with ongoing Phase II trials in BFPET, CardioPET and anticipated trials for VasoPET.

Download Full 7-Page Note with Important Disclosures: Morning Note 04-15-13 FPMI

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