WBB Securities, LLC
Morning Note
Stephen G. Brozak  sbrozak@wbbsec.com  (908) 518-7610
Navidea Biopharmaceuticals (NYSE Amex: NAVB) (04/03/2012) New analysis
comparing Lymphoseek to Sulfur Colloid and PDUFA Date Extension
WBB remarks on Navidea Biopharmaceuticals (NAVB) meta-analysis
of Lymphoseek® to sulfur colloid along with PDUFA Date Extension
WBB believes it is reassuring to see NAVB released data today confirmed by meta-analyses
statistics that in the breast cancer patients studied, 99m-Tc-Tilmanocept Lymphoseek's
Localization Rate was 99.91% by meta-analysis and 98.65% by pooled data analysis,
whereas the sulfur colloid Localization Rate derived from peer-reviewed literature was
94.13% (P<0.0001/meta-analysis; p<0.0015/pooled analysis). Similarly, Lymphoseek's
Degree of Localization in the breast cancer patients studies was 2.1 by meta-analysis and
2.2 by pooled data analysis, compared to the sulfur colloid Degree of Localization from
peer-reviewed literature of 1.6 (P<0.0001/meta-analysis; p<0.0001/pooled analysis).
NAVB said that the full data on the comparison of Lymphoseek and sulfur colloid will be
presented at the American Society for Clinical Oncology (ASCO) Annual Meeting, June 1-5,
2012 in Chicago, IL. This follows similarly encouraging data presented at a session of the
Sentinel Node Oncology Foundation and International Sentinel Lymph Node Working
Group in Orlando, Florida, March 20-21, 2012 showing the overall Phase 3 clinical trial
experience with Lymphoseek in intraoperative lymphatic mapping (ILM) in patients with
breast cancer and melanoma. We believe that these continuing data announcements
strengthen the clinical and commercial case for implementation of Lymphoseek.
In a separate press release also issued today NAVB announced that “yesterday it received
notification from the United States Food and Drug Administration (FDA) that the
Prescription Drug User Fee Act (PDUFA) date for Lymphoseek, has been modified to
September 10, 2012, a 90-day extension from the initial PDUFA date of June 10th. “
In reviewing the release we noted that NAVB had provided updated chemistry,
manufacturing and control information related to one of several drug analytical assays.
NAVB stated that “As this information was submitted within the 90-day period prior to the
PDUFA date, on April 2nd, FDA at its option elected to extend the review period by 90 days
to complete a first-cycle evaluation. Neither this FDA decision nor the NDA review-to-date
has raised questions on Lymphoseek's safety or efficacy. The PDUFA date extension does
not pertain to the Company's ongoing head and neck cancer clinical trial or to the recently
announced comparative analysis of Lymphoseek to sulfur colloid.”
We believe that this delay to be an administrative issue given the complex FDA submission
process and are comfortable with the ultimate approval of Lymphoseek given that neither
Safety nor Efficacy were items discussed and that the process still is on track for First-Cycle
Review. We maintain our Strong Buy rating with 12-month $9.00 Price Target.
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