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



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

  PR Newswire

  HATFIELD, England, May 7, 2013

HATFIELD, England, May 7, 2013 /PRNewswire/ --

                  Orphan status also granted in Switzerland

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-β 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 http://www.eisai.co.uk

References

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

2. A trial of E7080 in 131I-refractory differentiated thyroid cancer.
ClinicalTrials.gov Web site.

http://clinicaltrials.gov/ct2/show/study/NCT01321554 . 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 / Cressida
Robson, +44(0)7908-314-155, +44-(0)7947-231513, Cressida_Robson@eisai.net,
Charlotte_andrews@eisai.net; Tonic Life Communications, Siobhan Reilly / Moira
Gitsham, +44(0)207-798-9999 / +44-(0)7788-191434 siobhan.reilly@toniclc.com /
moira.gitsham@toniclc.com
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