Navidea announces FDA extension of Lymphoseek PDUFA date by three months

Navidea Biopharmaceuticals, Inc.Apr 4 2012

Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB) today 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 99m-Tc-Tilmanocept (Lymphoseek^®), has been modified to September 10, 2012, a 90-day extension from the initial PDUFA date of June 10th. Lymphoseek is an investigational, proprietary radioactive tracing agent for lymphatic mapping and lymphoscintigraphy.    

As part of its ongoing support of the Lymphoseek NDA review, on March 30, 2012, the Company provided as requested by the Agency, updated chemistry, manufacturing and control information related to one of several drug analytical assays. As this information was submitted within the 90-day period prior to the PDUFA date, on April 2^nd, 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 have submitted the information requested by the FDA in support of a first-cycle review of the Lymphoseek NDA," said Mark Pykett, Navidea President and CEO. "Our focus continues to be on supporting the FDA review and preparing for anticipated market introduction of Lymphoseek. All of the clinical data we have generated for Lymphoseek to date support a clear safety and efficacy profile, which we believe holds value to patients and their physicians."