Lymphoseek Update

On October 30, 2012, Navidea resubmitted its Lymphoseek new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in response to the complete response letter (CRL) the Company received in September 2012.

On September 10, 2012, Navidea announced that it had received a CRL from the FDA regarding the NDA for Lymphoseek (technetium Tc 99m tilmanocept) Injection. The CRL focused on current Good Manufacturing Practice (cGMP) deficiencies identified during inspections of third-party manufacturing facilities and did not cite any Lymphoseek clinical efficacy or safety issues. Since receipt of the CRL, the Company has worked diligently with its advisors, contract manufacturers and the FDA to address the deficiencies noted in the CRL. While the Company is unable to predict the timing for FDA review, it does believe that the focused scope of the CRL and the corresponding information provided in the Company’s response will facilitate a timely evaluation of the resubmission.

“We continue to believe the FDA review process will involve re-evaluation of only a small portion of the NDA and that the focused information we have provided will support a potentially expeditious review,” said Dr. Mark Pykett, Navidea President and CEO. “Our clear priority continues to be Lymphoseek approval and launch in the U.S. We are committed to providing this novel radiopharmaceutical for use in critical diagnostic procedures for medical professionals, cancer patients and their families.”

Other Recent Business and Program Highlights
  • Completed the sublicense agreement with Alseres Pharmaceuticals, Inc. for a second promising neuroimaging candidate. NAV5001 is an Iodine-123 radiolabeled imaging agent being developed as an aid in the diagnosis of Parkinson’s disease and other movement disorders and a potential use as a diagnostic aid in dementia.
  • Enrolled the first subject in a Phase 2 clinical trial of NAV4694, Navidea’s F-18 PET imaging agent being developed as an aid in diagnosing Alzheimer’s disease.
  • Received a Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) for development of our radioimmunoguided surgery (RIGS ®) agent aimed at detecting metastatic cancer, with potential funding of up to $1.5 million over three years if fully funded. The first-year Phase 1 funding of $315,000, which has already been approved, is expected to enable the Company to complete preclinical bridging activities using a RIGS tumor-antigen-targeted monoclonal antibody and prepare a standardized clinical trial protocol.
  • Published the results of Lymphoseek Phase 3 clinical trials in melanoma in the online edition of the journal Annals of Surgical Oncology. The data indicated that Lymphoseek met the primary efficacy endpoint in the assessment of lymphatic mapping performance in patients with cutaneous melanoma. The study was titled, “Combined Analysis of Phase III Trials Evaluating [99mTc]Tilmanocept and Vital Blue Dye for Identification of Sentinel Lymph Nodes in Clinically Node-Negative Cutaneous Melanoma,” [DOI 10.1245/s10434-012-2612-z].
  • Presented data on Lymphoseek at major scientific and medical conferences:
    • Lymphoseek Phase 3 meta-analysis data on Lymphoseek and radiolabeled colloidal agents presented at the 32 nd Congress of the European Society of Surgical Oncology by Dr. Frederick Cope.
    • Additional podium and poster presentations highlighting similar Lymphoseek Phase 3 results were made at: the American Association of Pharmaceutical Scientists , the European Association of Nuclear Medicine , and the American Society for Radiation Oncology.
  • Cornelia Reininger, M.D., Ph.D., joined Navidea as Chief Medical Officer. Previously, Dr. Reininger had a central role in the development of diagnostic radiopharmaceuticals for Alzheimer’s and Parkinson’s diseases for Bayer Healthcare Pharmaceuticals and GE Healthcare and Amersham Health – Diagnostic Imaging.

“We continue to make important progress toward a number of the clinical and regulatory objectives surrounding our product candidates,” said Dr. Pykett. “We realized several important advancements in our programs this quarter and we expect to report a number of further positive achievements in the coming months, not the least of which are U.S. approval and launch for Lymphoseek, filing of a Marketing Authorization Application for approval in the European Union and advancing our discussions with potential partners outside the U.S., all in an effort to make Lymphoseek available around the world to cancer surgery patients and their physicians. We expect these Lymphoseek milestones, coupled with activities following our recent RIGS grant and the planned initiation of Phase 3 clinical trials for NAV4694 and NAV5001, to serve as demonstrable examples of the robustness of our evolving precision diagnostics pipeline as we enter 2013.”

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