Innovative Metastatic Breast Cancer Treatment Halaven® (eribulin) is Available in Belgium

Innovative Metastatic Breast Cancer Treatment Halaven® (eribulin) is Available
                                  in Belgium

  PR Newswire

  HATFIELD, England, October 1, 2013

HATFIELD, England, October 1, 2013 /PRNewswire/ --

Country with highest global rate of breast cancer ^[ ^1]  welcomes treatment
              option with proven overall survival benefit ^[ ^2]

Halaven ^® (eribulin) has today received reimbursement approval in Belgium as
a novel treatment for patients with metastatic breast cancer. Eribulin is the
first, single-agent chemotherapy to demonstrate a prolonged overall survival
in patients with heavily pre-treated advanced breast cancer, compared to other
single agent chemotherapies ^[ ^2 ^] .

"The availability of eribulin in Belgium is a significant milestone for women
with advanced breast cancer," says Professor Ahmad Awada, Principal Study
Investigator and Head of the Medical Oncology Clinic at Jules Bordet
Institute, Brussels, Belgium. "Many women with metastatic breast cancer need
urgently new treatment options. Eribulin goes some way to address this unmet
need and provides patients and clinicians with an option that has a proven
overall survival benefit in heavily pretreated patients."

Belgium has a higher incidence of breast cancer than any other country in the
world with around one in every 10 women developing breast cancer each year ^[
^1 ^] . Of these cases, metastatic breast cancer develops in 30 percent of
women with an estimated 2,500 women dying from the condition. ^[3]

"We are pleased that the Belgian health authorities recognise the innovative
drug status and clinical value eribulin may offer to women with locally
advanced or metastatic breast cancer. The reimbursement in Belgium underscores
the potential importance of this treatment and is a positive step forward for
women affected by this disease. Eisai will work closely with local health
authorities to ensure that women in Belgium have rapid access to a treatment
that has a proven overall survival benefit," says Dr Nicolas Kormoss, Medical
Director for Belgium and Luxembourg, Eisai EMEA.

Eribulin received European Commission approval on 17 March 2011 based on the
results of the pivotal Phase III EMBRACE (Eisai Metastatic Breast Cancer Study
Assessing Treatment of Physician's Choice (TPC) Versus Eribulin E7389)
study.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 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 ^]

The most commonly reported adverse reactions among patients treated with
eribulin were asthenia (fatigue), neutropenia, alopecia (hair loss),
peripheral neuropathy (numbness and tingling in arms and legs), nausea and
constipation. ^[ ^2 ^]

Eisai is committed to developing and delivering highly beneficial new
treatments to help improve the lives of people with cancer. Built on
scientific expertise, Eisai 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.

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. ^[ ^4] ^, ^[ ^5] ^, ^[ ^6] 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. ^[ ^7] 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. ^[8] ^, ^[9]
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
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.
http://www.wcrf-uk.org/research/cancer_statistics/world_cancer_statistics_breast_cancer.php
Last accessed August 2013

2. Cortes J, O'Shaughnessy J, Loesch D, et al. Eribulin monotherapy versus
treatment of physician's choice in patients with metastatic breast cancer
(EMBRACE): a phase 3 open-label randomised study. The Lancet. 2011; 377: 914
-923

3. Globocan 2008 statistics. http://globocan.iarc.fr/factsheet.asp#WOMEN [
http://globocan.iarc.fr/factsheet.asp ]. Last accessed July 2013.

4. 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 

5. 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

6. 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

7. 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

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

9. Cancer Research UK. Breast cancer incidence statistics.
http://www.cancerresearchuk.org/cancer-info/cancerstats/types/breast/incidence/#world
[
http://www.cancerresearchuk.org/cancer-info/cancerstats/types/breast/incidence
]. Last accessed April 2013.



Date of preparation: October 2013

Job code: Halaven-UK0213



Contact: Media Enquiries, Eisai Europe Ltd, Cressida Robson / Charlotte
Andrews, +44(0)7908-314-155 / +44(0)7947-231-513, Cressida_Robson@eisai.net,
Charlotte_Andrews@eisai.net; Tonic Life Communications, Siobhan Reilly / April
Kenneally, +44(0)207-798-9999 / +44(0)207-798-9263,
siobhan.reilly@toniclc.com, april.kenneally@toniclc.com
 
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