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EU Regulatory Authorities Grant Orphan Status to Eisai's Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer

Update: Lenvima (lenvatinib) Now FDA Approved - February 13, 2015

Orphan status also granted in Switzerland

HATFIELD, England, May 7, 2013 /PRNewswire/ --The investigational multi-tyrosine kinase inhibitor (TKI), lenvatinib (development code: E7080), has today been granted orphan drug designation (ODD) for the treatment of follicular and papillary thyroid cancer by the European Commission.

ODD is for medicines developed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious. In the European Union (EU), a disease is defined as rare if it affects fewer than five in 10,000 people across the EU.

Lenvatinib received ODD from the Swiss agency for therapeutic products, Swissmedic, on 13 March 2013 for the treatment of follicular (FTC), medullary (MTC) and anaplastic (ATC) thyroid cancer. Orphan drug status was granted in February 2013 by the US Food and Drug Administration (FDA) in the treatment of FTC, MTC and ATC thyroid cancer. Japan's Ministry of Labour, Health and Welfare also granted ODD for thyroid cancer in August 2012.

"We are extremely pleased that lenvatinib has received orphan drug designation in the 27 countries of the EU plus Switzerland in the EMEA region. The ODD highlights the unmet need in the treatment of people with radioiodine-refractory differentiated thyroid cancer (RRDTC) and the important potential for this investigational drug. Eisai is dedicated to providing a new option for people with this difficult-to-treat form of the disease," says Gary Hendler, President & CEO Eisai EMEA & Russia.

Discovered and developed by Eisai in Europe and Japan, lenvatinib is an orally active, small molecule multi targeted tyrosine kinase inhibitor. It has a unique inhibitory mechanism acting on tyrosine kinases involved in angiogenesis (the formation of new blood vessels by cancerous tumours) and tumour proliferation. The results of clinical studies conducted to date, suggest that lenvatinib may be effective in the treatment of people with RRDTC, a life-threatening form of the disease, that has a significant unmet treatment need.[1]

A Phase III clinical trial (SELECT) of lenvatinib in people with RRDTC is currently underway across sites in Europe, North and South America and Asia.[2] Eisai has also initiated a global Phase III trial with lenvatinib in hepatocellular carcinoma (HCC) and is conducting Phase II studies of lenvatinib in several other tumours, including endometrial cancer, melanoma, and non-small cell lung cancer.

The development of lenvatinib underscores Eisai's human health care mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well being of people worldwide. Eisai is committed to the therapeutic area of oncology and addressing the unmet medical needs of patients and their families.

Notes to Editors

Lenvatinib (E7080)

Lenvatinib is an orally active inhibitor of multiple receptor tyrosine kinases (RTKs), including KDR (VEGFR-2), Flt-1 (VEGFR-1), FGFR1, PDGFR-beta and c-kit involved in angiogenesis and tumour proliferation.[3],[4] It is currently being investigated as a treatment for thyroid, hepatocellular, endometrial and other solid tumour types.

About Thyroid Cancer

Thyroid cancer refers to cancer that forms in the tissues of the thyroid gland, located at the base of the throat near the trachea. It is more common in women than in men and usually occurs between the ages of 25 and 65.

The most common types of thyroid cancer, papillary and follicular (including Hurthle cell), are classified as differentiated thyroid cancer (DTC) and account for approximately 95 percent of all cases. While most of these are curable with surgery and radioactive iodine treatment, a small percentage of patients do not respond to therapy. There are limited treatment options for this difficult-to-treat, life-threatening and treatment-refractory form of thyroid cancer.

Eisai in Oncology

Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, therapeutic vaccines, and biologic and supportive care agents for cancer across multiple indications.

About Eisai

Eisai is one of the world's leading research and development (R&D) based pharmaceutical companies.

Eisai concentrates its R&D activities in three key areas:

- Oncology including: anticancer therapies; tumour regression, tumour

suppression, antibodies, etc.

- Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight loss

- Vascular/Immunological reaction including: thrombocytopenia, rheumatoid

arthritis, psoriasis, inflammatory bowel disease

With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 10,000 people worldwide. From its Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East, Africa and Russia (EMEA). Eisai EMEA has sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic, Slovakia, the Netherlands, Belgium, the Middle East and Russia.

For further information please visit our web site


1. Data on file. Eisai Inc. Woodcliff Lake, NJ; 2011

2. A trial of E7080 in 131I-refractory differentiated thyroid cancer. Web site. Accessed November 2, 2011.

3. Matsui J, Funahashi Y, Uenaka T et al. Multi-kinase inhibitor E7080 suppresses lymph node and lung metastases of human mammary breast tumour MDA-MB-231 via inhibition of vascular endothelial growth factor-receptor (VEGF-R) 2 and VEGF-R3 kinase. Clin Cancer Res 2008; 14: 5459-65.

4. Matsui J, Yamamoto Y, Funahashi Y, et al. E7080, a novel inhibitor that targets multiple kinases, has potent anti-tumour activities against stem cell factor producing human small cell lung cancer H146, based on angiogenesis inhibition. Int J Cancer 2008; 122: 664-71.

Job code: Lenvatinib-UK0015

Date of preparation: May 2013

CONTACT: Media Enquiries: Eisai Europe Ltd, Charlotte Andrews / CressidaRobson, +44(0)7908-314-155, +44-(0)7947-231513,,; Tonic Life Communications, Siobhan Reilly /Moira Gitsham, +44(0)207-798-9999 / +44-(0) /

Posted: May 2013