Norgine launches LYMPHOSEEK^®▼ in Finland and Sweden

CORPORATE MEDIA RELEASE

NORGINE LAUNCHES LYMPHOSEEK^®▼ IN FINLAND AND SWEDEN

AMSTERDAM. The Netherlands. Thursday 11 January, 13:00 CET. Norgine B.V. today announced the launch of LYMPHOSEEK^® (Tc 99m tilmanocept) in Finland and Sweden. LYMPHOSEEK^® is a radiopharmaceutical used for diagnostic purposes by nuclear medicine specialists and surgeons. It is specifically designed for a procedure called sentinel lymph node biopsy (SLNB) and 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.

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.^[1],[2],[3] LYMPHOSEEK^® has a false negative rate of 2.6% in T1-T4cN0 oral squamous cell carcinoma (OSCC).^[1] It detected sentinel lymph nodes in 99% of patients with Tis, Tx or T1-T4cN0 breast cancer and in 97% of patients with T1-T4cN0 melanoma.^[1],[4]

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.^{[5],[6],[7],[8],[9],[10]}

Peter Martin, COO at Norgine commented: “By making LYMPHOSEEK^®  available to patients through our infrastructure in partnership with surgeons, radiopharmacists, and nuclear medicine specialists, we continue to demonstrate our commitment to improving patients’ quality of life with access to new innovative specialist diagnostic tools and treatments. Norgine wants all eligible patients suffering from oral cancer, breast cancer or melanoma 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’ outcomes.”

He added: “LYMPHOSEEK^® is already available through Norgine in the Netherlands, UK, Italy and Denmark. We are anticipating further launches through our Norgine infrastructure in 2018”.  

Norgine in-licensed LYMPHOSEEK^® from Navidea Biopharmaceuticals Inc for the commercialisation and distribution in Europe and certain other key markets. 

GL/LYM/0917/0046(1)

Ends

Notes to Editors:

About Norgine

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.

Media Contact:

Isabelle Jouin, T: +44 (0)1895 453643

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References

[1] Sondak VK, et al. Ann Surg Oncol 2013; 20(2): 680-688.

[2] LYMPHOSEEK^® Summary of Product Characteristics 2017.

[3] Vera DR, et al. J Nucl Med 2001; 42(6): 951-959.

[4] Wallace AM, et al. Ann Surg Oncol 2013; 20(8): 2590-2599.

[5] 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.

[7] Monroe MM, et al. Curr Oncol Rep 2014; 16(5): 385.

[8] Monroe MM, et al. Otolaryngol Clin North Am 2012; 45(5): 1181-1193

[9] Schiefke F, et al. Head Neck 2009; 31(4): 503-512.

[10] Murer K, et al. Head Neck 2011; 33(9): 1260-1264.