FDA Grants Orphan Drug Status To Eisai's Lenvatinib

             FDA Grants Orphan Drug Status To Eisai's Lenvatinib

PR Newswire

WOODCLIFF LAKE, N.J., Feb. 14, 2013

WOODCLIFF LAKE, N.J., Feb. 14, 2013 /PRNewswire/ --Eisai Inc. announced today
that the U.S. Food and Drug Administration (FDA) has granted orphan drug
designation to its investigational drug lenvatinib (E7080) for follicular,
medullary, anaplastic and metastatic or locally advanced papillary thyroid
cancer.

(Logo: http://photos.prnewswire.com/prnh/20120413/MM87168LOGO )

The Orphan Drug Act (ODA) allows FDA to grant orphan status to a drug which
has the potential for the treatment, diagnosis, or prevention of a rare
disease/disorder that affects fewer than 200,000 people in the United States.

Lenvatinib, discovered and developed by Eisai, is an investigational small
molecule tyrosine kinase inhibitor being studied globally as an oral agent in
patients with radioiodine-refractory differentiated thyroid cancer (DTC).

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 resistant form of thyroid
cancer.

Eisai Oncology
Eisai Oncology is dedicated to discovering, developing and producing
innovative oncology therapies that can help make a difference and impact the
lives of patients and their families. This passion for people is part of
Eisai's human health care (hhc) mission, which is to help address unmet
medical needs and to increase the benefits health care provides to patients
and their families. 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,
biologic and supportive care agents for cancer across multiple indications.

Eisai Inc.
Eisai Inc. was established in 1995 and began marketing its first product in
the United States in 1997. Since that time, Eisai Inc. has rapidly grown to
become a fully integrated pharmaceutical business. Eisai's key areas of
commercial focus are neurology and oncology. The company serves as the U.S.
pharmaceutical operation of Eisai Co., Ltd., a research-based human health
care (hhc) company that discovers, develops and markets products throughout
the world.

Eisai has a global product creation organization that includes U.S.-based R&D
facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as
well as manufacturing facilities in Maryland and North Carolina. The company's
areas of R&D focus include neuroscience; oncology; vascular, inflammatory and
immunological reaction; and antibody-based programs. For more information
about Eisai, please visit www.eisai.com/US.

Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that
discovers, develops and markets products throughout the world. Through a
global network of research facilities, manufacturing sites and marketing
subsidiaries, Eisai actively participates in all aspects of the worldwide
healthcare system.

Media Inquiries Investor Inquiries
Laurie Landau   Alex Scott
Eisai Inc.      Eisai Inc.
201-746-2510    201-746-2177

SOURCE Eisai Inc.

Website: http://www.eisai.com/US
 
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