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FDA Grants Fast Track Designation To Navidea Biopharmaceuticals’ Lymphoseek® For Sentinel Lymph Node Detection In Patients With Head And Neck Cancer

Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation to Lymphoseek ® (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer. Under the FDA Modernization Act of 1997, the Fast Track program was designed to facilitate the development and expedite the review of drug candidates intended to treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. Navidea intends to file the supplemental New Drug Application (sNDA) for Lymphoseek before year-end. Lymphoseek was approved by the FDA in March 2013 for use in lymphatic mapping procedures that are performed to help in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma.

“The Fast Track designation Navidea has received for Lymphoseek recognizes the significant unmet need that exists in the treatment of head and neck cancers and the important role that Lymphoseek can play in reducing or eliminating the need for debilitating elective neck dissection surgery,” said William J Regan, Navidea Senior Vice President for Global Regulatory Strategy. “After filing the sNDA, we look forward to working closely with the FDA to bring to market as quickly as possible an expanded label for Lymphoseek and what will be the first agent indicated in sentinel lymph node detection."

Lymphoseek NEO3-06 Clinical Trial Results

Navidea’s Phase 3 clinical trial (NEO3-06) of Lymphoseek was a prospective, open-label, multicenter, within-patient study of Lymphoseek ® (technetium Tc 99m tilmanocept) Injection. It was designed to identify sentinel lymph nodes (SLNs) and determine the false negative rate (FNR) associated with Lymphoseek-identified SLNs relative to the pathological status of non-SLNs in head and neck and intraoral squamous cell carcinoma. The primary endpoint for the NEO3-06 trial was based on the number of subjects with pathology-positive lymph nodes (lymph nodes found to harbor cancer) following a multiple level lymph node dissection and required a minimum of 38 subjects whose lymph nodes contained pathology-confirmed disease. Of the more than 80 subjects enrolled in the NEO3-06 trial, 39 subjects were determined to have pathology-positive lymph nodes. Results demonstrated that Lymphoseek correctly identified 38 of these 39 patients, for an overall False Negative Rate (FNR) of 2.56%. This was statistically significant (p=0.0205) against the statistical threshold for success. These findings indicate that Lymphoseek accurately identified SLNs in these trial subjects, and is likely to be predictive of overall node pathology status. FNR is the rate of occurrence of negative test results in subjects known to have the disease for which the individual is being tested. Moreover, multiple level nodal dissection of patients in the trial with cancer-positive lymph nodes led to an average removal of 38 lymph nodes per patient, whereas Lymphoseek on average led to the removal of approximately 4 lymph nodes, representing a substantial reduction in potential morbidity for patients with head and neck cancer undergoing single lymph node biopsy. The study also reported no differences were observed in the ability of Lymphoseek to detect SLNs between same-day or subsequent-day surgery following Lymphoseek injection, and also evaluated the use of Lymphoseek in lymph node imaging, or lymphoscintigraphy.

About Lymphoseek ®

Lymphoseek ® (technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical used in lymphatic mapping procedures that are performed to help in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma. Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek was approved by the U.S. Food and Drug Administration in March, 2013 for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma. The Company anticipates continuing development of Lymphoseek into other solid tumor areas that may include head and neck cancers, prostate cancer, thyroid cancer, lung/bronchus cancers, colorectal cancer and others.

Accurate diagnostic evaluation of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. According to the American Cancer Society, approximately 232,000 new cases of breast cancer, 77,000 new cases of melanoma and 67,000 new cases of head and neck/oral cancer are expected to be diagnosed in the United States in 2013.

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