Navidea joins forces with Norgine to market cancer imaging Dx in EU

Navidea CEO Rick Gonzalez

Navidea Biopharmaceuticals ($NAVB) is teaming up with European specialty pharma company Norgine to commercialize its Lymphoseek cancer diagnostic aid in Europe, looking to make a market splash as it drives international growth.

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, Navidea CEO Rick Gonzalez said in a statement.

"Launching Lymphoseek into new global markets is integral to Navidea's corporate growth strategy," he said. "We believe that Norgine's commercial, medical and development expertise, combined with its well-established infrastructure and strong presence in the European marketplace, make it an ideal commercialization partner to gain country-by-country reimbursement and drive Lymphoseek adoption."

Norgine's experience in European markets also helps Navidea navigate a different access scheme. In the U.S., healthcare providers deal with specialized distributors to get radiopharmaceutical products like Lymphoseek. But in Europe, healthcare institutions buy the material and compound the finished product on site. Norgine is "optimally positioned" to deal directly with a targeted surgical oncologist customer base in Europe and brings a "dedicated sales force" to the table, Gonzalez said in a statement.

Meanwhile, Navidea has continued to generate upward momentum for Lymphoseek after winning FDA approval for the product in 2013. In June 2014, the company secured the agency's blessing 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, expanding the market for its product overseas.

And at least so far, Navidea's hard work seems to be paying off. The company reported $6.3 million in 2014 revenue, up from $1.1 million in 2013. Navidea also brought in $4.2 million in product revenue from Lymphoseek in 2014, compared to $614,000 in Lymphoseek sales in 2013.

- read Navidea's statement