2 February 2012 - US Navidea Biopharmaceuticals Inc (NYSEAMEX:NAVB) said on Thursday it had received the positive stance of the Committee for Medicinal Products for Human Use (CHMP) with the European Medicines Agency (EMA) for its Lymphoseek product allowing it to file a Marketing Authorisation Application (MAA) in the EU.

Taking the advice of the Scientific Advice Working Party (SAWP) regarding the Lymphoseek development programme, the CHMP concluded that the product was eligible for an MAA submission.

Accordingly, Navidea has started activities to submit an MAA to the EMA for Lymphoseek by the end of the current year.

Lymphoseek (Kit for the Preparation of Technetium Tc 99m Tilmanocept for Injection) is a radioactive diagnostic tracing agent being developed for use in connection with gamma detection devices in a surgical oncology procedure known as intraoperative lymphatic mapping (ILM).

Navidea will seek approval to market Lymphoseek for use in ILM and in lymphoscintigraphy imaging procedures.

The company filed a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for Lymphoseek in August 2011 and is awaiting feedback related to the 10 June 2012 PDUFA date.

Navidea has finalised two Phase III multi-centre clinical trials for Lymphoseek in patients with breast cancer or melanoma. A third Phase III clinical trial to assess the efficacy of Lymphoseek as a sentinel lymph node tracing agent in patients with head and neck squamous cell carcinoma is currently underway. No drug-related serious adverse events or clinically significant drug-related adverse events have been found in over 500 study participants receiving Lymphoseek to date.