Life-extending Metastatic Breast Cancer Treatment Now Available in the Republic of Ireland

    Life-extending Metastatic Breast Cancer Treatment Now Available in the
                             Republic of Ireland

  PR Newswire

  HATFIELD, England, January 6, 2014

HATFIELD, England, January 6, 2014 /PRNewswire/ --

Halaven ^® (eribulin) has today received reimbursement approval in the
Republic of Ireland as a treatment for patients with locally advanced or
metastatic breast cancer who have progressed after at least two
chemotherapeutic regimens for advanced disease. Prior therapy should have
included two common types of chemotherapy, an anthracycline and a taxane,
unless patients were not suitable for these treatments. ^[1] Eribulin is the
first, single-agent chemotherapy to demonstrate a prolonged overall survival
benefit for metastatic breast cancer patients within this setting compared to
other available single agent treatments. ^[2]

"I am pleased that eribulin will be available to Irish public patients with
advanced breast cancer," says Professor John Crown, Consultant Medical
Oncologist at St Vincent's University Hospital, Dublin, Ireland. "It is active
and offers the prospect of additional precious months of disease control to
these women."

Breast cancer is the second most common form of cancer amongst Irish women.
^[3] One in ten women in Ireland will develop breast cancer and more than
2,600 new cases are diagnosed each year. ^[ ^3 ^] In almost ten percent of
cases, ^[4] breast cancer is metastatic at diagnosis with a five-year survival
rate of only 21 percent. ^[5] Ireland has the fourth highest breast cancer
mortality rate across 30 European countries, ^[ ^4 ^] however a recent report,
published by St James's Hospital Dublin, has shown significant improvements in
cancer survival rates over the last decade. ^[6]

Gary Hendler, President and CEO, Eisai EMEA commented: "Eribulin will play an
important role in improving the treatment and outcomes of metastatic breast
cancer in Ireland. We are delighted that the innovative drug status and
clinical value of eribulin has been recognised and that women will now have
access to the drug. Its reimbursement in Ireland underscores the need to
ensure that women with metastatic breast cancer have access to treatments that
are best suited to their needs."

Eribulin received European Commission (EC) approval on 17 March 2011 based on
the results of the Phase III EMBRACE study (Eisai Metastatic Breast Cancer
Study Assessing Treatment of Physician's Choice (TPC) Versus Eribulin E7389).
^[ ^2 ^] Eribulin is now available in 50 countries worldwide.

In the EMBRACE study population (n=762), eribulin was shown to prolong overall
survival in heavily pre-treated patients with metastatic breast cancer by 2.5
months compared to patients receiving Treatment of Physicians Choice (TPC),
representing a mix of real-life treatment choices (eribulin 13.1 months vs.
TPC 10.6 months, HR 0.81 (95% CI 0.66, 0.99) p=0.041). ^[ ^2 ^] Updated data
from the trial confirmed these results, showing that patients treated with
eribulin survived a median of 2.7 months longer than patients who received
treatment of physician's choice (overall survival of 13.2 months versus 10.5
months, respectively, HR 0.81 (95% CI 0.067, 0.96), nominal p=0.014). ^[ ^2 ^]
A pre-planned analysis of patients from Region 1 of the study (North
America/Western Europe/Australia) showed a significant overall survival
benefit of eribulin over TPC of 3.0 months (p=0.009). ^[ ^2 ^]

Eisai is dedicated to discovering, developing and producing innovative
oncology therapies that can make a difference and impact the lives of women
and their families. This passion for people is part of Eisai's human health
care (hhc) mission, which strives for better understanding of the needs of
patients and their families to increase the benefits health care provides.

                                 *** ENDS ***

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. ^[7] ^, ^[8] ^, ^[9] 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. ^[10] 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.

Global Phase III Clinical Study 305 (EMBRACE) ^[ ^2 ^]

EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of
Physician's Choice (TPC) Versus Eribulin E7389) was an open-label, randomised,
global, multi-centre, parallel two-arm study designed to compare overall
survival in patients treated with eribulin versus a Treatment of Physician's
Choice (TPC) arm. TPC was defined as any single-agent chemotherapy, hormonal
treatment or biologic therapy approved for the treatment of cancer; or
palliative treatment or radiotherapy administered according to local practice.
The study included 762 patients with metastatic breast cancer who previously
had been treated with at least two and a maximum of five prior chemotherapies,
including an anthracycline and a taxane. The vast majority (96%) of patients
in the TPC arm received chemotherapy.

In the total Phase III EMBRACE study population, eribulin was shown to prolong
median overall survival in heavily pre-treated patients with metastatic breast
cancer compared to patients receiving TPC by 2.7 months (13.2 vs 10.5 HR 0.81
(95% CI 0.067, 0.96) nominal p=0.014). A pre-planned analysis of patients from
Region 1 of the study (North America/Western Europe/Australia) showed a
significant median overall survival benefit of eribulin over TPC of 3.0 months
(nominal p=0.031).

The most commonly reported adverse reactions among patients treated with
eribulin in the EMBRACE study were fatigue (asthenia), a decrease in
infection-fighting white blood cells (neutropaenia), hair loss (alopecia),
numbness and tingling in arms and legs (peripheral neuropathy), nausea and
constipation. Peripheral neuropathy was the most common adverse event leading
to discontinuation from eribulin, occurring in less than 5% of the patients
involved in the EMBRACE trial. Neutropaenia only led to eribulin
discontinuation for 0.6% patients. Death due to serious side effects,
discontinuation and dose interruptions to treatment were lower in the eribulin
arm of the trial compared with the TPC arm.

Metastatic Breast Cancer

Over 300,000 women are diagnosed with breast cancer in Europe every year, of
whom about one third subsequently develop metastatic disease. ^[11] ^, ^[12]
Metastatic disease is an advanced stage of the disease that occurs when cancer
spreads beyond the breast to other parts of the body.

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

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
  *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


1. SPC Halaven (updated August 2013). Available at: . Last accessed December 2013

2. Cortes J, et al. The Lancet. 2011; 377: 914-923

3. Irish Cancer Society. Breast Cancer - the key facts. Available from:
(Last accessed October 2013)

4. National Medicines Information Centre, St James' Hospital, Ireland
(Last accessed October 2013)

5. Cardoso, M., Castiglione F. Ann Oncol 2009; 20 Suppl 4: iv15-iv18

6. Cancer Audit Programme Team, St James's Hospital. Ten year cancer audit
report 2003-2013

7. 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

8. 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

9. 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

10. 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

11. World Health Organization. Atlas of Health in Europe. 2003. World Health
Organization, Regional Office of Europe, Copenhagen, Denmark.

12. Cancer Research UK. Breast cancer incidence statistics.
]. Last accessed October 2013.

Job code: Halaven-UK0220

Date of preparation: December 2013

Contact: Media Enquiries: Eisai Europe Ltd, Cressida Robson / Charlotte
Andrews, +44(0)7908-314-155 / +44(0)7947-231-513 ,, , Tonic Life Communications, Siobhan Reilly /
April Kenneally, +44(0)207-798-9999 / +44(0)207-798-9263,,
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