Navidea: Revenue from Lymphoseek leaps 83% in first quarter

Navidea Biopharmaceuticals, developers of Lymphoseek and novel NAV4694 announced its first quarter 2014 financial report Wednesday including word of $752,000 revenue over absolutely zero revenue for that period last year.  

Revenue from Lymphoseek in the first quarter was $627,000 in contrast to $343,000 during the fourth quarter of 2013 just as sales began to pick up with the U.S. Centers for Medicare & Medicaid Services (CMS) reimbursing for the lymph node mapping agent.

"As we begin 2014, we are encouraged by the continued advances in utilization, market penetration and account growth for Lymphoseek,” Mark Pykett, Navidea Chief Executive Officer, said in a press release. “We are realizing increasing traction in our commercial and medical education activities directed toward surgical oncologists and major lymphatic mapping centers,”

For the remainder of 2014, Navidea is seeking further regulatory approval for Lymphoseek as well as developments in phase II and III trials for neurodegenerative imaging agents that target movement disorders, cognitive impairment and dementia, namely NAV4694.

This quarter saw a priority review by the FDA for a supplemental new drug application to include lymph node detection in head and neck patients on the labeling for Lymphoseek and an additional application to expand utilization of the drug.

The company noted that a marketing authorization application has been submitted for Lymphoseek in Europe and that the Committee for Medicinal Products for Human Use will be reviewing Navidea’s application for marketing in the region. Navidea also listed areas of market expansion, including Taiwan, Canada and areas of the Middle East.

Earlier in development is Manocept, an agent being evaluated for the localization of macrophage activity in immune-mediated arthritis and Kaposi sarcoma.