Navidea appoints Norgine to market Lymphoseek cancer diagnostic aid in EU

Navidea Biopharmaceuticals is combining with Norgine to commercialize its Lymphoseek cancer diagnostic aid in Europe.Under the terms of the deal Navidea will provide its injectable imaging agent to Norgine and will transfer regulatory, pricing, reimbursement, sales, marketing and medical affairs upkeep to the company. In return, Navidea will receive an upfront payment of $2 million, as much as $5 million in milestones and any royalties on European sales of its product. Norgine will begin working on marketing Lymphoseek "immediately" and the companies expect to launch the product sometime in early 2016.

In June 2014, Navidea secured FDA approval to market Lymphoseek for use in head and neck cancer patients. The product, which is designed to map the spread of cancer in patients undergoing surgery, was already approved for use in breast cancer and melanoma procedures. In November 2014, the company won EU regulatory approval for Lymphoseek.

Comment:Lymphoseek competes with two primary imaging agents, Blue Dye and Sulfur Colloid. These agents are injected into the patient, circulate through the lymph tissue, and help doctors identify lymph nodes that are thought to indicate disease (sentinel nodes) by visual assessment or using nuclear medicine probes. Once suspected lymph nodes are identified, a surgeon removes those nodes through a lymph biopsy and assesses them for metastatic disease.