NORGINE AND NAVIDEA ENTER INTO EXCLUSIVE LICENSING DEAL FOR LYMPHOSEEK

LONDON, Thursday 5 March 2015, 12:00 GMT[CA1] . Norgine has today announced that its subsidiary SpePharm AG has entered into an exclusive sublicense agreement with Navidea Biopharmaceuticals Inc for the commercialisation and distribution in the European Union of LYMPHOSEEK^® (technetium Tc 99m tilmanocept) injection.

Radiolabelled LYMPHOSEEK^® is approved in Europe for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity.[1]

LYMPHOSEEK^® is designed to locate the sentinel lymph nodes and map lymph node drainage from these cancers.

Cancer of the head and neck affects 100,000 people in Europe every year.[2] In a study of patients with intra-oral or cutaneous squamous cell head and neck cancer, the overall accuracy of LYMPHOSEEK^® correctly identifying metastatic cancer in local lymph nodes was 98.8%.¹ This means that patients could avoid the potentially disfiguring surgery currently used to stage their cancer.

Peter Stein, Chief Executive Officer, Norgine said: “Our partnership with Navidea is further example of Norgine’s commitment to supportive care in oncology. Cancer is a devastating disease and requires specialised therapies to aid in the correct detection and staging of the disease. This truly innovative medicine and first of its type, will aid in the accurate staging of cancers,  therefore enabling healthcare professionals and patients to choose the best course of treatment.[CA2]

Rick Gonzalez, President and Chief Executive Officer commented: “Expanding LYMPHOSEEK^® utilisation into new global markets is integral to Navidea’s corporate growth strategy, and we believe that Norgine’s specialty sales and marketing expertise, combined with its well-established infrastructure and strong presence in the European marketplace, make it an ideal commercialisation partner to gain country-by-country reimbursement and drive LYMPHOSEEK^® adoption.”[CA3]

The receptor-targeted, radiopharmaceutical imaging agent was approved by the U.S. Food and Drug Administration in 2013 and by the European Medicines Agency in November 2014. 

Under the terms of the agreement, Navidea will receive an upfront payment of $2million and is eligible to receive additional sales-based milestone payments of up to $5million, plus royalties on European net sales. Additional financial terms of the agreement are not disclosed.

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Notes to editors

About Lymphoseek

Radiolabelled LYMPHOSEEK^{® (}technetium Tc 99m tilmanocept) is approved in Europe for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity.

LYMPHOSEEK^® is designed to locate the sentinel lymph nodes and map lymph node drainage from these cancers.

Navidea will supply packasged LYMPHOSEEK product to Norgine; however, Navidea will transfer responsibility for regulatory maintenance of the LYMPHOSEEK Marketing Authorization to Norgine. Norgine will also be responsible for sales and marketing, medical affairs, regulatory and reimbursement support. The initial territory covered by the agreement includes the 28 countries in the European Union with the option to expand into additional geographical areas.

About Norgine

Norgine is a leading independent European specialty pharmaceutical company that has been established for over 100 years and has a presence in all major European markets. Norgine’s focus is the development and marketing of pharmaceutical products that address significant unmet clinical needs in therapeutic areas such as gastroenterology, hepatology, critical and supportive care. Norgine owns a manufacturing and development site in Hengoed, UK and a manufacturing site in Dreux, France. In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US.  For more information, please visit www.norgine.com

About Navidea Biopharmaceuticals Inc.

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a commercial stage precision medicine company focused on the development and commercialization of precision diagnostics, therapeutics and radiopharmaceutical agents. Navidea is developing multiple precision-targeted products and platforms including Manocept™, NAV4694, and NAV5001, to help identify the sites and pathways of undetected disease and enable better diagnostic accuracy, clinical decision-making, targeted treatment and, ultimately, patient care. Lymphoseek^® (technetium Tc 99m tilmanocept) injection, Navidea’s first commercial product from the Manocept platform, was approved by the FDA in March 2013 and by the EMA in November 2014. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel radiopharmaceutical agents and therapeutics, and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.

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