Date: 2015-03-05
Type of information: Commercialisation agreement
Compound: Lymphoseek® (technetium Tc 99m tilmanocept)
Company: SpePharm (The Netherlands), affiliate of Norgine (The Netherlands) Navidea Biopharmaceuticals (USA - OH)
Therapeutic area: Cancer - Oncology - Diagnostic
Type agreement: commercialisation distribution
Action mechanism: radiopharmaceutical. Lymphoseek® (technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical used in lymphatic mapping procedures that are performed to help stage breast cancer and melanoma. Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer, in patients with breast cancer or melanoma. Lymphoseek® has been approved by the FDA in 2013 and by the EU in November 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.
Disease: imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity
Details: * On March 5, 2015, Navidea Biopharmaceuticals and SpePharm, an affiliate of Norgine, a European specialist pharmaceutical company with an extensive pan-European presence, entered into an exclusive sublicense agreement for the commercialization and distribution of Lymphoseek® 250 microgram kit for radiopharmaceutical preparation (tilmanocept) in the European Union. Under terms of the exclusive license agreement, Navidea will supply 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 pricing, reimbursement, sales, marketing, medical affairs, and regulatory. The initial territory covered by the agreement includes all 28 member states of the European Economic Community with the option to expand into additional geographical areas.Additional terms of the agreement were not disclosed.
Financial terms: In connection with entering into the agreement, Navidea will be entitled to an upfront payment of $2 million, milestones totaling up to an additional $5 million, as well as royalties on European net sales.
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