FDA Grants Orphan Drug Status To Morphotek's Amatuximab (MORAb-009)

     FDA Grants Orphan Drug Status To Morphotek's Amatuximab (MORAb-009)

PR Newswire

EXTON, Pa., Nov. 12, 2012

EXTON, Pa., Nov. 12, 2012 /PRNewswire/ --Morphotek^® Inc., a subsidiary of
Eisai Inc., announced today that the United States Food and Drug
Administration (FDA) has granted orphan drug designation to its
investigational cancer drug, amatuximab (MORAb-009) for the treatment of
malignant pleural mesothelioma, the most common form of mesothelioma, which
accounts for around 2,500 cases a year in the United States. This disease
affects the pleura, which is the thin balloon shaped lining of the lungs.^1

The Orphan Drug Act (ODA) allows FDA to grant orphan status to a drug which
has the potential for the safe and effective treatment, diagnosis, or
prevention of a rare disease/disorder that affects fewer than 200,000 people
in the United States.^2 Under the ODA, orphan designation qualifies the
sponsor of the product for certain incentives, such as tax credits,
prescription drug user fee waivers for the development product, and a seven
year period of marketing exclusivity from the date of approval. ^

"We are very pleased to receive orphan drug designation for amatuximab for the
potential treatment of malignant pleural mesothelioma," said Julia Maltzman,
M.D., Senior Director of Clinical Development at Morphotek. "We believe that
addressing unmet medical needs, no matter the size of the patient population,
is essential to the achievement of our human health care mission, which is to
give first thought to patients and their families and to helping increase the
benefits that health care provides. Ultimately, this antibody has the
potential to provide an additional treatment option for patients suffering
from an extremely serious disease."

Amatuximab (MORAb-009) is an investigational chimeric IgG1 antibody that
targets a cell surface glycoprotein, mesothelin, which is over-expressed in a
number of cancers. Mesothelin is thought to be involved in cell adhesion. Its
presence is associated with a range of cancers, including pancreatic ductal
adenocarcinoma, mesothelioma, epithelial ovarian cancer, and lung
adenocarcinoma. Researchers at the National Cancer Institute (NCI) and the
Johns Hopkins University have independently validated mesothelin as a
potential target of immuno-based therapies.

About Morphotek

Morphotek^® Inc., a subsidiary of Eisai Inc., is a biopharmaceutical company
specializing in the development of protein and antibody products through the
use of a novel and proprietary gene evolution technology. The technology has
been successfully applied to a broad variety of cell lines and organisms to
yield genetically diverse offspring that are suitable for pharmaceutical
product development in the areas of antibody therapeutics, protein
therapeutics, product manufacturing, drug target discovery, and improved
output traits for commercial applications. The company is currently focusing
its platform on the development and manufacturing of therapeutic antibodies
for the treatment of cancer, inflammation and infectious disease. For more
information, please visit www.morphotek.com.

About Eisai Inc.

Eisai Inc. was established in 1995 and began marketing its first product in
the United States in 1997. Since that time, Eisai 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.

^1Mesothelioma Applied Research Foundation What is Mesothelioma. Available at
http://www.curemeso.org/site/c.kkLUJ7MPKtH/b.8050629/k.6568/What_is_Mesothelioma.htm
A. Pg. 1, col. 1, par. 4

^2U.S Food and Drug Administration (FDA) Designating an Orphan Product: Drugs
and Biologics. Available at
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/default.htm
A. Pg. 1, col. 1, par. 1

SOURCE Morphotek Inc.

Website: http://www.morphotek.com
Contact: Media Inquiries, Terry Cushmore, Morphotek, Inc., +1-610-423-6197,
tcushmore@morphotek.com; or Investor Inquiries, Rod Dausch, Morphotek, Inc.,
+1-610-423-6111, Dausch@morphotek.com; or Media Inquiries, Lynn Kenney, Eisai
Inc., +1-201-746-2294, lynn_kenney@eisai.com; or Investor Inquiries, Alex
Scott, Eisai Inc., +1-201-746-2177, alex_scott@eisai.com