LYMPHOSEEK USED IN SENTINEL LYMPH NODE BIOPSY MAY BE AN ALTERNATIVE TO ELECTIVE NECK DISSECTION TO STAGE ORAL CANCER

• 7.2% of studied patients were left with a cancerous lymph node when elective neck dissection surgery was used to stage the cancer ¹

London. Sunday 16 October 2016. 15:00 BST. Norgine B.V. today presented new data from a phase III study* showing that LYMPHOSEEK^® (^99mTc-tilmanocept) used with sentinel lymph node biopsy, could be an alternative to the current standard of care in oral cavity squamous cell carcinoma. In current practice, patients with early oral cancer undergo major surgery to remove the lymph nodes to evaluate if the cancer has spread. Sentinel lymph node biopsy is a simple procedure to remove and examine the first nodes where cancer cells may be present. These data were presented at the European Association of Nuclear Medicine (EANM) 2016, Spain. [1]

LYMPHOSEEK^® is highly predictive in the neck of patients with early oral cancer who had no clinical lymph node involvement. The data further demonstrate that if elective neck dissection had been used without sentinel lymph node biopsy, a cancer positive contralateral node may have been missed in 7.2% of the studied patients. In a small number of cases this was the only cancer positive lymph node. ¹

LYMPHOSEEK^® was well tolerated by the studied population. [2]

In major European markets**, there were 76,917 new cases of head and neck cancer diagnosed in 2014. [3]

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. External imaging and intraoperative evaluation may be performed using a gamma detection device. [4]

Dr Alastair Benbow, Chief Development & Medical Officer, Norgine commented: “Data show the use of LYMPHOSEEK^® in sentinel lymph node biopsy for early oral cancer may provide a benefit to patients. ⁶ Currently, up to 70-80% of patients with early oral cancer receive elective neck dissection that may be potentially avoidable. This invasive procedure can result in further complications, morbidity and have a significant impact on patient lives. [5] This new data demonstrates that if elective neck dissection had been used without sentinel lymph node biopsy, a cancer positive contralateral node may have been missed in 7.2% of the studied patients.” ¹

LYMPHOSEEK^® data presented at EANM included:

• Sentinel lymph node biopsy using ^99mTc-tilmanocept (LYMPHOSEEK^®) in patients with oral cavity squamous cell carcinoma: Safety results from Phase III clinical trial. Session 407, OP123. 16 October, 14:30-16:00.
• Bilateral and Contralateral Sentinel Node Identification with ^99mTc-Tilmanocept (LYMPHOSEEK^®) in Oral Cavity Squamous Cell Carcinoma Patients. Session 407, OP124. 16 October, 14:30-16:00.
• In-use stability of ^99mTc-tilmanocept (LYMPHOSEEK^®), a sentinel lymph node detection agent. EP534. 16 October, 09:00 – 19 October, 12:00.

Ends

*For original analysis see A. Agrawal et al. 2015 [6]

**Countries included were France, Germany, Italy, Spain and the United Kingdom.

About LYMPHOSEEK^®

LYMPHOSEEK^® 50 micrograms kit for radiopharmaceutical preparation is the first and only FDA and EMA approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. 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 Norgine

Norgine is a European specialist pharmaceutical company that has been established for over 100 years. In 2015, Norgine’s total revenue was EUR 320 million and the company employs over 1,000 people.

Norgine provides expertise and ‘know how’ in Europe to develop, manufacture and market products that offer real value to healthcare professionals, payers and patients.  Norgine’s approach and infrastructure is integrated and focused upon ensuring that Norgine wins partnership opportunities for growth.

Norgine is headquartered in the Netherlands and its global operations are based in Amsterdam and in Harefield, UK. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites, one in Hengoed, Wales and one in 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 U.S. For more information, please visit www.norgineventures.com.

NORGINE and the sail logo are trademarks of the Norgine group of companies.

Media Contacts:

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

Charlotte Andrews, T: +44 (0)1895 453607

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GL/LYM/0916/0012. October 2016

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