Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that on October 30, 2012 it filed the resubmission of its Lymphoseek ® New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in response to the Complete Response Letter (CRL) received in September 2012. Lymphoseek (technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule, investigational radiopharmaceutical used in lymphatic mapping procedures that are performed to help stage cancer. Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.
“The Company’s resubmission of the Lymphoseek NDA is an important step for cancer patients and medical professionals in moving this novel radiopharmaceutical into the practice of medicine,” said Mark Pykett, V.M.D., Ph.D., President and CEO of Navidea Biopharmaceuticals. “We have been working diligently with our advisors, contract manufacturers and the FDA to address the third-party cGMP manufacturing deficiencies noted in the FDA’s September CRL. While we are unable to predict the timing for FDA review, we believe that the focused scope of the CRL and the corresponding information provided in the Company’s responses will facilitate a timely evaluation of the resubmission. Upon Lymphoseek’s approval, we stand prepared to move forward quickly with our U.S. commercialization partner, Cardinal Health.”
Dr. Pykett added, “We continue to believe the FDA review process will involve re-evaluation of only a small portion of the NDA concerning third-party manufacturer cGMP compliance and that the focused information we have provided will support a potentially expeditious review. Our clear priority continues to be Lymphoseek approval and launch in the U.S. We are also committed to advancing the development and potential market introduction of this important radiopharmaceutical innovation globally, including filing our Marketing Authorization Application (MAA) 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 to cancer surgery patients and their physicians worldwide. We also look forward to continuing to advance the other assets in our promising, late-stage pipeline of precision diagnostic agents addressing cancer, Alzheimer’s disease and Parkinson’s disease.”