Navidea Biopharmaceuticals Inc (NAVB)

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FDA Approves Expanded Use of Navidea’s Lymphoseek® for Lymphatic Mapping in Solid Tumors
http://ir.navidea.com/phoenix.zhtml?c=68527&p=irol-newsArticle&ID=1977807

FDA Approves Expanded Use of Navidea’s Lymphoseek® for Lymphatic Mapping in Solid Tumors
- Lymphoseek® (technetium Tc 99m tilmanocept) Injection Use for Sentinel Lymph Node detection also expanded to include Breast Cancer and Melanoma -

- Expanded Lymphoseek indication increases the addressable market with the potential to benefit up to 1.2 million solid tumor patients in U.S. annually -

- Company to Host Conference Call on Wednesday, October 15, 2014, 8:30 a.m. EDT -

DUBLIN, Ohio--(BUSINESS WIRE)--Oct. 15, 2014-- Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Application (sNDA) for the expanded use of Lymphoseek® (technetium Tc 99m tilmanocept) injection for lymphatic mapping in solid tumors and adding Sentinel Lymph Node detection for breast cancer and melanoma to the approved indications. Lymphoseek is now indicated for:

Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management
Guiding Sentinel Lymph Node Biopsy (SLNB) using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma (SCC) of the oral cavity, breast cancer or melanoma.
The FDA also allowed expanded utilization of Lymphoseek with or without scintigraphic imaging, known as lymphoscintigraphy, to enable pre-operative imaging and mapping of lymph nodes to facilitate node localization during surgical procedures. Lymphoseek is the first and only FDA-approved radiopharmaceutical agent for sentinel lymph node detection, is the only FDA-approved agent for lymphatic mapping of solid tumors, and will be immediately available using existing reimbursement codes for this expanded population of cancer patients.

“Lymphoseek is the now the only agent approved by the FDA for lymphatic mapping across solid tumors when used as a component of surgical management. This significantly expands the potential market for Lymphoseek and materially enhances the Company’s ability to promote the use of Lymphoseek in solid tumor cancers where assessment of lymphatic involvement is critical to properly staging the disease, especially colorectal, gynecological, lung and prostate cancers,” said Michael Goldberg, M.D., Interim Chief Executive Officer. “We are highly encouraged by the expanded FDA approval and believe that Lymphoseek now has the potential to become a standard-of-care in lymphatic mapping and sentinel lymph node biopsy for the staging and prognosis of upwards of 1.2 million patients diagnosed with solid tumors annually in the U.S. We are eager to discuss the new label with surgeons and oncologists whose patients should benefit from the improved data resulting from better utilization of lymphatic mapping and Sentinel Lymph Node Biopsy procedures.”

“Based on our clinical experience in melanoma and head and neck cancers, Lymphoseek appears to be an effective agent for cancer staging to guide pre- and intra-operative patient management and post-surgical treatment thereby avoiding unnecessary surgical interventions, reducing surgical time and limiting potential complications with associated morbidity,” commented Dr. Stephen Y. Lai, M.D., Ph.D., FACS, Associate Professor, Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center. “The ability of Lymphoseek to accurately identify sentinel lymph nodes in patients, demonstrated in clinical evidence from more than 500 patients, may not only improve diagnostic accuracy, but also enable more efficient and appropriate patient care and provide us with greater precision during surgery to detect lymph nodes with the highest likelihood of harboring tumor metastases.”

“The success of lymphatic mapping and sentinel lymph node biopsy is dependent upon a radiopharmaceutical’s ability to concentrate in the lymph nodes most likely to contain cancer,” said H. William Strauss, M.D., Attending Physician Emeritus, Molecular Imaging and Therapy Service at Memorial Sloan-Kettering Cancer Center. “Lymphoseek, with its specifically-designed ability to target molecular markers in tumor-draining lymph nodes, has shown through clinical studies in breast cancer, melanoma and certain head and neck cancers, to possess a high degree of sensitivity and accuracy. Based on the reliable performance of Lymphoseek as demonstrated in these tumor-types, this approval opens up potential diagnostic imaging opportunities broadly across all forms of solid tumors.”

The expanded approval is supported by data from Navidea’s combined analysis of Lymphoseek’s pivotal prospective Phase 3 data in melanoma, breast cancer, and certain head and neck cancers from more than 500 subjects. An integrated analysis of data from all three studies showed positive diagnostic performance of Lymphoseek across the solid tumor types studied. The findings indicate that Lymphoseek accurately identified lymph nodes for assessment in the trial subjects, and is likely to be predictive of overall node pathology status. To date, no clinically significant drug-related adverse reactions have been reported. Lymphoseek has no contraindications and the most common adverse reactions were injection site irritation and/or pain (<1%).

In the approval action letter, the FDA also outlined a post-marketing requirement for initiation of a pediatric study in solid tumor cancer with a target date for submission in 2018.

Conference Call Details

Navidea will host a conference call with the investment community to discuss the sNDA scheduled for Wednesday, October 15, 2014 at 8:30 a.m. EDT. Investors and the public are invited to access the live webcast through the link below. Participants who would like to ask questions during the question and answer session following the presentation must participate by telephone also. Participants are encouraged to log-in and/or dial-in fifteen minutes before the conference call begins. The webcast replay is expected to be available on our investor website, http://ir.navidea.com, approximately two to four hours after the live event.

Event: Navidea Biopharmaceuticals sNDA Approval Call
Date/Time: Wednesday, October 15, 2014 at 8:30 a.m. EDT
Webcast Link:
http://public.viavid.com/index.php?id=111146

Dial-in Number – US: 1-877-407-0789
Dial in Number – Int’l: 1-201-689-8562
Replay
A webcast replay will be available on the Investor Relations section of our website at http://ir.navidea.com.