Navidea: FDA Grants Orphan Drug Status For Lymphoseek In Head, Neck Cancers

(RTTNews) - Navidea Biopharmaceuticals Inc (NAVB) said Thursday the U.S. Food and Drug Administration has granted orphan drug status to Lymphoseek (technetium Tc 99m tilmanocept) Injection for use in sentinel lymph node detection in patients with cancer of the head and neck.

The orphan drug status is based upon an estimated 40,000 procedures being performed in this patient population.

The FDA provides a special status to drugs and biologics intended to treat, diagnose or prevent rare, or 'orphan', diseases and disorders, defined as affecting fewer than 200,000 people in the U.S.

This designation provides for a seven-year marketing exclusivity period against competition in head and neck cancers as well as certain incentives, including federal grants, tax credits and a waiver of PDUFA filing fees, which qualifies the Company to request a refund of previously paid filing fees of up to $1.1 million.

Lymphoseek Injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients with breast cancer, melanoma and head and neck cancer patients with oral cavity carcinoma.

Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the FDA for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma and for use in guiding sentinel lymph node biopsy in head and neck cancer patients with squamous cell carcinoma of the oral cavity. The company anticipates continuing development of Lymphoseek into other solid tumor areas.

Navidea stock closed Thursday at $1.33, up $0.04 or 3.10%, on a volume of 871k shares on the NYSE. In after hours, the stock gained $0.07 or 5.26%.