We expect Norgine to begin market access work immediately in the major markets in Europe with the goal of supporting commercial launch sometime in early 2016.”
the meat of the deal,
DUBLIN, Ohio--(BUSINESS WIRE)--Mar. 5, 2015-- Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) and SpePharm AG (an affiliate of Norgine BV), a European specialist pharmaceutical company with an extensive pan-European presence, today entered into an exclusive sublicense agreement for the commercialization and distribution of Lymphoseek® 250 microgram kit for radiopharmaceutical preparation (tilmanocept) in theEuropean Union. Under the terms of the agreement, Navidea will receive an upfront payment of $2 million and is eligible to receive additional milestone payments up to $5 million, as well as royalties on European net sales.
Lymphoseek is a receptor-targeted, radiopharmaceutical imaging agent approved by the U.S. Food and Drug Administration in 2013 and by the EU inNovember 2014. Lymphoseek is approved in Europe for imaging and intraoperative detection of sentinel lymph nodes in patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity. In these procedures, key lymph nodes adjacent to a primary tumor, that may contain tumor metastases, are identified and biopsied to determine if cancer has spread to these lymph nodes.
“Launching Lymphoseek into new global markets is integral to Navidea’s corporate growth strategy. 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,” said Rick Gonzalez, President and Chief Executive Officer of Navidea. “We anticipate a successful and mutually-beneficial partnership with Norgine based on synergistic core competencies, our shared vision for value creation and our strong commitment to providing highly-differentiated products that improve the diagnosis and treatment of disease for patients with unmet medical needs.”
“This agreement with Navidea underscores Norgine’s vision to be the partner of choice and facilitates the growth and expansion of our specialist product portfolio to help improve the treatment of patients throughout Europe,” said Peter Stein, Chief Executive Officer of Norgine. “We look forward to fully engaging our sales force to support commercial launch activities in a marketplace requiring a new alternative.”
Bupp was slow but Norgine is in no hurry. Now they need to hire someone.