Farletuzumab Data Presented on Phase II Clinical Trial in First-Relapsed Ovarian Cancer Subjects

Berlin (ots/PRNewswire) -

Morphotek(R), Inc., a subsidiary of Eisai Corporation of North
America, today announced preliminary data from a Phase II trial
evaluating the safety and efficacy of farletuzumab in
platinum-sensitive epithelial ovarian cancer subjects experiencing
their first relapse. Farletuzumab (MORAb-003) is a humanized
monoclonal antibody that targets the Folate Receptor Alpha (FRA).
(1A)

These data were presented today at the joint 15th Congress of the
European Cancer Organisation (ECCO) and the 34th Congress of the
European Society for Medical Oncology (ESMO) by Deborah Armstrong,
M.D., Associate Professor of Oncology, Johns Hopkins Kimmel Cancer
Center and a farletuzumab study investigator.

Preliminary data from the study indicate that farletuzumab, in
combination with standard platinum and taxane chemotherapy, shrank or
eliminated the tumor in 69.8% of subjects; in addition, 23% of the
subjects had their tumor stabilized.(2A) The results of the study
also showed that in more than 20% of subjects the second
progression-free interval was as long as or longer than the
first.(2B)

The most common drug-related adverse events observed in this
study were fever and chills related to infusion, which tended to be
mild. No significant increase in severe adverse events above those
expected with chemotherapy alone was reported during combination
therapy.(2C)

"The rate of relapse of ovarian cancer is high, and over time
standard chemotherapeutic agents become ineffective in treating
relapsed ovarian cancer patients," said Martin D. Phillips, M.D.,
Chief Medical Officer at Morphotek. "We are excited about these new
data and look forward to seeing results from our ongoing global Phase
III trial testing farletuzumab in combination with platinum and
taxane in platinum-sensitive ovarian cancer."

"The results of this Phase II study presented today support our
commitment to continue to develop farletuzumab for ovarian cancer,"
said Nicholas C. Nicolaides, Ph.D., President and CEO of Morphotek.
"Our research with farletuzumab is consistent with our human health
care (hhc) mission - addressing unmet medical needs by developing new
treatment options that will improve the lives of patients."

Study Details

The primary objectives of the open-label Phase II study included:
to measure overall response rate (ORR), to compare the length of a
subject's second remission with her first remission and to measure
change in CA-125 level.(3A) Approximately 20 centers in the United
States, Germany and the Netherlands participated in the study.

Thirty-nine (88.6%) of the 44 eligible subjects receiving
farletuzumab in combination with platinum and taxane had their CA-125
blood levels normalized,(2D) and three additional subjects had a 50%
decrease.(2E) (According to the National Cancer Institute, CA-125 is
a tumor marker frequently elevated in ovarian cancer. It is typically
used to evaluate tumor response, as CA-125 levels generally correlate
with tumor activity.)(4A) In nine (20.5%) of these 44 subjects, the
second remission was equal to or longer than the first remission.(2F)

About Ovarian Cancer

Ovarian cancer forms in the tissue of the ovary. Most ovarian
cancers are epithelial carcinomas (cancer that begins in the cells on
the surface of the ovary).(5A)

Ovarian cancer, which ranks fifth as the cause of cancer deaths
in women,(6A) usually grows asymptomatically before it is
discovered.(7A) In Europe, it is estimated that there are 61,000
cases of ovarian cancer each year.(8A) The National Cancer Institute
estimates that there were 21,550 new cases of ovarian cancer in the
United States in 2009 and 14,600 deaths from the disease.(5B)

About Farletuzumab

Farletuzumab (MORAb-003) is a humanized monoclonal antibody in
development for the potential treatment of advanced ovarian cancer.
In vitro, farletuzumab appears to have antiproliferative and
cytotoxic activities in tumor cells that over express FRA.

A randomized global Phase III study to test farletuzumab in
combination with platinum and taxane (P/T) in platinum-sensitive
ovarian cancer subjects is currently underway.(9A) For more
information about the Phase III trial, please visit
www.far-trials.com or www.clinicaltrials.gov.

About Morphotek

Morphotek(R), Inc., a subsidiary of Eisai Corporation of North
America, is a biopharmaceutical company specializing in the
development of protein and antibody products through the use of a
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 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.

Eisai Corporation of North America

Eisai Corporation of North America is a wholly-owned subsidiary
of Eisai Co., Ltd. and supports the activities of its operating
companies in North America. These operating companies include: Eisai
Research Institute of Boston, Inc., a discovery operation with strong
organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical
company specializing in the development of therapeutic monoclonal
antibodies; Eisai Medical Research Inc., a clinical development
group; Eisai Inc., a commercial operation with manufacturing and
marketing/sales functions; and Eisai Machinery U.S.A., which markets
and maintains pharmaceutical manufacturing machinery.

Eisai in Europe

Eisai Europe Limited (EEL) is a wholly-owned subsidiary of Eisai
Co., Ltd. and supports the activities of its operations across
Europe, where Eisai 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, Iceland, Czech Republic, Hungary, and Slovakia. In
addition, other Eisai operating companies in Europe carry out basic
discovery research; distribution & logistics; clinical research; and
manufacturing.

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 health care system. Eisai employs
approximately 11,000 employees worldwide.

Eisai concentrates its R&D activities in three key areas:
- Integrative Neuroscience, including Alzheimer's disease,
neuropathic pain and epilepsy.
- Integrative Oncology, including anticancer therapies, tumor
regression, tumor suppression and antibodies; supportive cancer
therapies include nausea and vomiting.
- Vascular/Immunological Reaction including acute coronary
syndrome, atherothrombotic disease and sepsis.

(1) Morphotek, Inc. and Eisai Corporation of North America ESMO
abstract. "Efficacy and safety of farletuzumab, a humanized
monoclonal antibody to folate receptor alpha, in platinum-sensitive
relapsed ovarian cancer subjects: preliminary data from a phase-2
study."

A. Pg. 1, col. 1, par. 1
B. Pg. 1, col. 1., par 3

(2) Deborah Armstrong, MD. Johns Hopkins University/Kimmel Cancer
Center. "Exploratory Phase 2 Efficacy Study of MORAb-003, a
Monoclonal Antibody against Folate Receptor Alpha, in
Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse." Joint
ECCO 15 - 34th ESMO Multidisciplinary Congress Slide Presentation.

A. Pg. 20, col. 1, par. 1
B. Pg. 23, col. 1, par. 3
C. Pg. 22, col. 1, par. 2 and 3
D. Pg. 15, col. 1, par. 1 and 2
E. Pg. 15, col. 2, par. 2 (Rustin response)
F. Pg. 15, col. 1, par. 3

(3) Morphotek, Inc. Clinical Trial Protocol: MORAb-003-002,
Morphotek, Inc., "A Study of the Efficacy of MORAb-003 in Subjects
with Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse."
Revised April 9, 2007.

A. Pg. 8, col. 1, par. 6

(4) National Cancer Institute. CA-125. Available at
http://www.cancer.gov/Templates/db_alpha.aspx?CdrID=46490. Accessed
September 10, 2009.

A. Pg. 1, col. 1., par. 1

(5) National Cancer Institute. Ovarian Cancer. Available at:
http://www.cancer.gov/cancer_information/cancer_type/ovarian/.
Accessed September 10, 2009.

A. Pg. 1, col. 1, par. 1
B. Pg. 1, col. 1, par. 2

(6) American Cancer Society. Cancer Statistics 2009 Slide. Slide
2. Available at: http://www.cancer.org/docroot/PRO/content/PRO_1_1_Ca
ncer_Statistics_2009_Pres entation.asp. Accessed September 10, 2009.

A. Pg. 2, col. 2, par. 1

(7) National Cancer Institute. Ovarian Cancer Symptoms. Available
at: http://www.cancer.gov/cancertopics/wyntk/ovary/page5. Accessed
September 11, 2009.

A. Pg. 1, col. 1., par 1 and 4

(8) Cancer Intelligence, sponsored by Professor Gordon McVie,
former Chief Executive of The Cancer Research Campaign and joint
Chief Executive of the new charity Cancer Research UK and current
consultant at the European Institute of Oncology. Ovarian Cancer.
Available at:
http://www.ecancermedia.com/Ovarian_Cancer_Factsheet.aspx. Accessed
September 11, 2009.

A. Pg. 4, col. 1, par. 10

(9) Morphotek, Inc. Clinical Trial Protocol: MORAb-003-004,
Morphotek, Inc., "A Randomized, Double-blind, Placebo-Controlled,
Phase 3 Study to Assess the Efficacy and Safety of Weekly
Farletuzumab (MORAb-003) in Combination with Carboplatin and Taxane
in Subjects with Platinum-sensitive Ovarian Cancer in First Relapse."
Revised February 2, 2009.

A. Pg. 2, col. 1., par 2

Nonpro-EU2004

ots Originaltext: Morphotek(R), Inc.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Judee Shuler, Eisai Inc., +1-201-746-2241, judee_shuler@eisai.com; or
Robert Laverty, Eisai Corporation of North America, +1-201-746-2265,
robert_laverty@eisai.com