CORPORATE MEDIA RELEASE
LYMPHOSEEK®▼ (99mTc-tilmanocept) LAUNCHES IN EUROPE
NEW RADIOPHARMACEUTICAL OFFERS ‘NEXT GENERATION’ STANDARD OF DIAGNOSIS WHEN UNDERTAKING SENTINEL LYMPH NODE BIOPSY
Amsterdam, The Netherlands. Monday 12 June 2017. 08:00 CET. Norgine B.V. today announces the launch of LYMPHOSEEK® (technetium Tc 99m tilmanocept) in Denmark, the Netherlands and the UK. LYMPHOSEEK® is a ‘next generation’ radiopharmaceutical which, when used in sentinel lymph node biopsy (SLNB), represents a significant alternative to the current method of identifying sentinel lymph nodes in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity.
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LYMPHOSEEK® has been specifically designed to target, bind to and be retained in sentinel lymph nodes, the first lymph node (or group of nodes) to which cancer cells are most likely to spread from a primary tumour.,, LYMPHOSEEK® has a false negative rate of 2.6% in T1-T4cN0 oral squamous cell carcinoma (OSCC).1 It detected sentinel lymph nodes in 98% of patients with Tis, Tx or T1-T4cN0 breast cancer and T1-T4cN0 melanoma.1,
LYMPHOSEEK® offers particular value in identifying lymphatic drainage from tumours in the floor of the mouth (underneath the tongue) which can prove especially difficult.6 Currently up to 70-80% of patients with early oral cancer receive elective neck dissection surgery, a major procedure which could be avoided by using sentinel lymph node biopsy (SLNB) for staging.,,,,, In major European markets*, 76,917 new cases of head and neck cancer were diagnosed in 2014.
“The mouth and neck areas are packed with vital structures affecting sight, hearing, taste and smell and essential functions such as breathing, swallowing and speech, all of which may be damaged during head and neck surgery,” said Professor Mark McGurk, Consultant Surgeon at the Head & Neck Oncology Unit, University College Hospital London. “Adopting SLNB to stage their disease means that the majority of early stage oral cancer patients can avoid a neck dissection and, for them, unnecessary procedure.”
LYMPHOSEEK® was specifically designed to improve upon colloids, the currently-used radiopharmaceuticals. It binds rapidly to the sentinel lymph nodes – within 15 minutes – and is retained in those nodes for up to 30 hours.2 This combination results in a smoother, more efficient patient journey, with flexibility to schedule administration, imaging and SLNB surgery. The European nuclear medicine/radiopharmaceuticals market is expected to reach $1.62 billion by 2020 from $1.09 billion in 2015, growing at a CAGR of 8.2% from 2015 to 2020.
“Using LYMPHOSEEK® in sentinel lymph node biopsy has the potential to impact positively on patients, surgeons and use of hospital resources,” commented Professor John Buscombe, Director of Nuclear Medicine, Addenbrooke’s Hospital, Cambridge. “Early experience suggests LYMPHOSEEK® can support a managed and scheduled transition of patients from imaging to surgery, lessening the amount of time both patients and surgical teams wait around as they can be confident that LYMPHOSEEK® is retained in the lymph nodes to inform ‘next day’ surgery.”
“Peter Martin, Chief Operating Officer, Norgine commented: “As a European multi-specialist pharma company, Norgine aims for all eligible patients to have their cancers accurately staged using sentinel lymph node biopsy with LYMPHOSEEK®. This will result in a reduction in unnecessary surgical interventions that can optimise use of healthcare resources and improve patients’ quality of life.”
Norgine in-licensed LYMPHOSEEK® from Navidea Biopharmaceuticals Inc for the commercialisation and distribution in Europe and certain other key markets.
*Countries included were France, Germany, Italy, Spain and the United Kingdom.
Notes to Editors:
LYMPHOSEEK® 50 microgram kit for radiopharmaceutical preparation 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.2 External imaging and intraoperative evaluation may be performed using a gamma detection device.2 LYMPHOSEEK® is designed for the precise identification of lymph nodes that drain from a primary tumour, which have the highest probability of harbouring cancer.
About Sentinel lymph node biopsy
This is a diagnostic procedure which involves surgical removal of the first lymph node or group of nodes (the sentinel node) which drain directly from the primary cancer site. It is a surgical procedure which requires an overnight stay in hospital and usually has no significant morbidity attached to it.
About Elective neck dissection
This is the planned removal of cervical lymph nodes in the neck. It is a significant surgical procedure requiring a stay in hospital of approximately 5 nights and has potentially significant morbidity risks such as neuropathic pain and reduced shoulder movement.
Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2016, Norgine’s total revenue was EUR 368 million. Norgine employs over 1,000 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sale and supply.
Norgine specialises in gastroenterology, hepatology, cancer and supportive care.
Norgine is headquartered in the Netherlands. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites in Hengoed, Wales and Dreux, France.
For more information, please visit www.norgine.com
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.norgineventures.com.
NORGINE and the sail logo are trademarks of the Norgine group of companies.
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GL/LYM/0217/0026h. June 2017
 Sondak VK, et al. Ann Surg Oncol 2013; 20(2): 680-688.
 LYMPHOSEEK® Summary of Product Characteristics 2017.
 Vera DR, et al. J Nucl Med 2001; 42(6): 951-959.
 Wallace AM, et al. Ann Surg Oncol 2013; 20(8): 2590-2599.
 Schmitz S, et al. Eur Arch Otorhinolaryngol 2009; 266(3): 437-443.
6 O’Connor R, et al. J Craniomaxillofac Surg 2013; 41(8): 721-727.
 Monroe MM, et al. Curr Oncol Rep 2014; 16(5): 385.
 Monroe MM, et al. Otolaryngol Clin North Am 2012; 45(5): 1181-1193
 Schiefke F, et al. Head Neck 2009; 31(4): 503-512.
 Murer K, et al. Head Neck 2011; 33(9): 1260-1264.
 Incidence of head and neck cancer in Europe. Norgine data on file. DOF-LYMPH-002