Norgine and Navidea Enter a European Partnership for LYMPHOSEEK®
05 Mar, 2015, 12:15 GMT
LONDON, March 5, 2015 /PRNewswire/ --
First ever medicine of its type for the detection and staging of metastasized cancers
Norgine has today announced that its affiliate SpePharm AG has entered into an exclusive sublicense agreement with Navidea Biopharmaceuticals Inc for the commercialisation and distribution in Europe and certain other key markets of LYMPHOSEEK® (technetium Tc 99m tilmanocept) injection.
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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 acquire specialist pharmaceutical products. 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."
Rick Gonzalez, President and Chief Executive Officer, Navidea 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."
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.
See release on http://www.norgine.com
References
1. SmPC Lymphoseek 250 micrograms kit for radiopharmaceutical preparation. Available online: http://ec.europa.eu/health/documents/community-register/2014/20141119129982/anx_129982_en.pdf
2. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. Available online: http://globocan.iarc.fr/Default.aspx
Contact: Charlotte Andrews, +44(0)7714-061-485
SOURCE Norgine B.V.