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30.10.2009 – 09:35

Eisai Co. Ltd.

Global Phase III Study Results Show Eribulin Meets Primary Endpoint Of Overall Survival

London (ots/PRNewswire)

- Eisai Plans to Submit Marketing Authorization Applications for.
Eribulin Mesylate in Locally Advanced or Metastatic Breast Cancer
Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo
Naito) today announced preliminary results from a recently completed
Phase III study with E7389 (generic name: eribulin mesylate,
"eribulin"), discovered and developed by the Company, in patients
with locally advanced or metastatic breast cancer.
This global Phase III study, known as "EMBRACE," (Eisai
Metastatic Breast Cancer Study Assessing Physician's Choice Versus
E7389), was an open-label, randomized, parallel two-arm, multi-center
study of 762 women(1) with locally recurrent or metastatic breast
cancer previously treated with at least two and a maximum of five
prior chemotherapy regimens, including an anthracycline and a
taxane.(2)
The patients were treated either with eribulin (administered
intravenously over two to five minutes on days 1 and 8 every 21 days)
or with treatment of physician's choice.(3) Treatment of physician's
choice is defined as any single agent chemotherapy, hormonal
treatment or biological therapy approved for the treatment of cancer;
or palliative treatment or radiotherapy administered according to
local practice.(4)
Preliminary results from the study demonstrated a statistically
significant improvement in overall survival, the primary endpoint, in
eribulin-treated patients compared with the physician's choice of
therapy. The safety profile of eribulin in this Phase III study was
consistent with the adverse events seen in previous Phase II clinical
studies and the most common adverse event reported was
myelosuppression.
Eribulin is a new chemical compound discovered and developed by
Eisai. It is a synthetic analogue of halichondrin B, a
naturally-derived compound that was first isolated from a marine
sponge. While taxanes inhibit cell division by stabilising
microtubules, eribulin is a microtubule dynamics inhibitor that
arrests the cell cycle through inhibition of the growth of
microtubules without interfering with microtubule shortening.
While early detection by breast cancer screening and the
development of innovative anti-cancer drugs have contributed to the
decline in breast cancer mortality around the world, breast cancer
remains one of the leading causes of cancer death in women. Although
advances are being made every year in the treatment of breast cancer,
women with locally advanced or metastatic breast cancer have limited
treatment options and the development of more effective treatment or
anti-cancer drugs is critically important.
Eisai will complete a more detailed analysis of the data prior to
submitting marketing authorization applications for eribulin to
health authorities in Japan, the United States, and Europe for
locally advanced and metastatic breast cancer by the end of the
fiscal year 2009.
Eisai is currently conducting clinical trials of this compound
in-house to evaluate the efficacy and safety not only in breast
cancer, but also in non-small cell lung cancer (NSCLC), hormone
refractory prostate cancer, and sarcoma. Eisai also includes eribulin
as one of the compounds in the co-development projects based on the
strategic collaboration agreement with Quintiles and will proceed
with joint clinical development of this compound for NSCLC as well as
bladder cancer.
Eisai defines oncology as a therapeutic area of focus and is
committed to developing novel anti-cancer agents and treatments for
supportive care. With these efforts, Eisai will make further
contributions to addressing the diversified needs of and improving
benefits to patients and families affected by cancer as well as
healthcare professionals.
For more information about eribulin, health care professionals
and patients in Europe may call +44 (0) 845-676-5200 or send
enquiries to eumedinfo@eisai.net.
Eisai Europe Ltd
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.
[Please refer to the following notes for a glossary of terms]
Note to editors:
About locally advanced and metastatic breast cancer
Breast cancer is staged from Stage 0 to Stage IV, based on the
size of the breast lump, whether lymph nodes are involved, and
whether the distant metastases have developed. Locally advanced
breast cancer, also known as Stage III, is invasive breast cancer
that has spread to axillary lymph nodes, the chest wall, skin of the
breast, or above or below the collarbone. Metastatic breast cancer,
considered Stage IV, is diagnosed when cells from the original breast
tumour have spread beyond the breast to other parts of the body,
usually the liver, bone, brain, or lungs.
It is believed that more than one million women are newly
diagnosed with breast cancer each year around the world.(5)
About overall survival
Overall survival is defined as the time from the date of
randomisation until the date of death from any cause.
References:
(1) Data on file
(2) Eisai Clinical Study Protocol, The "EMBRACE" Trial: Eisai
Metastatic Breast Cancer Study Assessing Physician's Choice Versus
E7389, Final Incorporating Amendment 1, Version Date: 08 August 2006.
Page 1, par. 3
(3) Ibid page 8, par.1
(4) Ibid, page 8, par.2
(5) Freddie Bray, Peter McCarron, D Maxwell Parkin, "The changing
global patterns of female breast cancer incidence and mortality."
Breast Cancer Res 2004; 6(6);229-239
Available at:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1064079/
Nonpro-EU2005

Contact:

Bob Laverty, Eisai Inc., +1-201-746-2265 (office), +1-201-937-2591
(mobile); Judee Shuler, Eisai Inc., +1-201-746-2241 (office),
+1-908-337-2540 (mobile)

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