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Eisai Oncology to Present Data Analyses on Halaven® (eribulin) at 36th Annual San Antonio Breast Cancer Symposium



Eisai Oncology to Present Data Analyses on Halaven® (eribulin) at 36th Annual
                     San Antonio Breast Cancer Symposium

  PR Newswire

  HATFIELD, England, December 5, 2013

HATFIELD, England, December 5, 2013 /PRNewswire/ --

Eisai announced today that four abstracts highlighting new study results will
be presented during the 2013 San Antonio Breast Cancer Symposium. The meeting
will be held 10-14 December 2013 at the Henry B. Gonzalez Convention Center in
San Antonio, Texas.  

The studies highlight Eisai's current and ongoing clinical research efforts
with eribulin and reinforce the company's commitment to the breast cancer
community.

"As part of Eisai's human health care mission, Eisai gives first thought to
patients and their families by developing drugs for diseases with unmet
medical need," said Kenichi Nomoto, Ph.D., President, Oncology Product
Creation Unit at Eisai. "Nowhere is this more compelling than in oncology, one
of Eisai's long-standing therapeutic areas of focus."

The following Eisai abstracts have been accepted for presentation at this
year's San Antonio Breast Cancer Symposium:


        Product/
    Poster Number    Abstract Name

    Eribulin         Eribulin mesylate as first-line therapy for locally
    P3-13-05         recurrent or metastatic HER2-negative breast cancer: Results
                     of a phase 2, multicenter, single-arm study McIntyre et al.
    Eribulin         Phase 2, multicenter, single-arm study of eribulin mesylate
    P4-12-12         + trastuzumab as first-line therapy for locally recurrent or
                     metastatic HER2-positive breast cancer
                     Wilks et al.

    Eribulin         A phase III, open-label, randomized study of eribulin versus
    P3-13-03         capecitabine in patients with metastatic breast cancer
                     (MBC): Effect of post-progression anti-cancer treatments
                     (PPT) and metastatic progression events on overall survival
                     Awada et al.

    Eribulin         Effect of age on tolerability and efficacy of eribulin and
    P3-13-04         capecitabine in patients with metastatic breast cancer
                     treated in study 301
                     Kaufman et al.

The information discussed in this release is about investigational uses for a
European Commission approved product. It is not intended to convey conclusions
of efficacy and safety.

Notes to Editors

Halaven ^®   (eribulin)

Eribulin is a non-taxane, microtubule dynamics inhibitor indicated for the
treatment of patients with breast cancer who have previously received at least
two chemotherapeutic regimens for metastatic disease and whose prior therapy
should have included an anthracycline and a taxane.Eribulin belongs to a class
of antineoplastic agents, the halichondrins, which are natural products,
isolated from the marine sponge Halichondria okadai. It is believed to work by
inhibiting the growth phase of microtubule dynamics without affecting the
shortening phase and sequesters tubulin into non-productive aggregates.
Research indicates that eribulin may have a novel inhibitory effect on tumour
metastasis by suppressing the expression in epithelial-mesenchymal transition
(EMT) gene sets. ^[1] ^, ^[2] ^, ^[3] EMT is a phenomenon in which cells
acquire characteristics that allow them to develop into tumours and is highly
significant in the infiltration and metastasise of cancer.

Further analysis of the MOA for eribulin has shown that eribulin also improves
blood perfusion in tumour tissues meaning that it increases the amount of
oxygen available to tumours. ^[4] When tumours are deprived of oxygen they are
more likely to metastasise and as such eribulin works to inhibit metastasis.
Following treatment with eribulin, tumours were less aggressive and invasive.

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 and we define our corporate mission as "giving first
thought to patients and their families and to increasing the benefits health
care provides," which we call human health care ( hhc ).

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 EMEA
Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business
operations to include Europe, the Middle East, Africa, Russia and Oceania
(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, Luxembourg, Russia and the Middle East.

For further information please visit our web site http://www.eisai.co.uk

References

1. McCracken P.J, Ito. K, Yanagimachi M, et al. Eribulin alters vascular
function in human triple-negative (TN) breast MX-1 and MDA-MB-231 tumor
xenograft models as measured by DCE-MRI. AACR abstract 2013 abstract # 4502  

2. Dezso Z, Oestreicher J, Weaver A et al. Gene expression profiling (GEP)
reveals Epithelial Mesenchymal Transition (EMT) genes selectively
differentiating eribulin sensitive breast cancer cell lines. AACR abstract
2013 abstract # 1522

3. Agoulnik SI, Oestreicher JL, Taylor NH et al. Eribulin and Paclitaxel
differentially affect gene expression profiling of blood vessel cells and in
vitro angiogenesis in co-cultures of human endothelial cells with pericytes.
AACR abstract 2013 abstract # 3830

4. Matsui J, Toyama O, Ino M et al. Eribulin caused re-modeling of tumor
vasculature altering gene expression profiling in angiogenesis and Epithelial
Mesenchymal Transition (EMT) signaling pathway of host cells within human
breast cancer cell (BCC) xenografts in nude mice. AACR abstract 2013 abstract
# 1413

Date of preparation: December 2013

Job code: Halaven-0288

Contact: Media Enquiries: Eisai Europe Ltd, Charlotte Andrews / Cressida
Robson, +44 (0)7947 231513, +44 (0)790 831 4155, charlotte_andrews@eisai.net /
cressida_robson@eisai.net; Tonic Life Communications, Siobhan Reilly / April
Kenneally, +44 (0)207 798 9999 / +44(0)784 047 3199, +44 (0)207 798 9263 /
+44(0)788 561 4274, siobhan.reilly@toniclc.com / april.kenneally@toniclc.com
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