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Innovative Metastatic Breast Cancer Treatment Halaven® (Eribulin) Recieves Reimbursement Approval in the Czech Republic



  Innovative Metastatic Breast Cancer Treatment Halaven® (Eribulin) Recieves
                 Reimbursement Approval in the Czech Republic

  PR Newswire

  HATFIELD, England, January 6, 2014

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

Halaven ^®  (eribulin) has received reimbursement approval in the Czech
Republic as a highly innovative drug for patients with metastatic breast
cancer, effective from the 1 January 2014. 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. ^[1]

"The reimbursement of eribulin in the Czech Republic is an important step
forward for women with metastatic breast cancer," says Professor MUDr.
Bohuslav Melichar, PhD, the Scientific Secretary of the Czech Society for
Oncology. "These patients urgently need new treatment options and in
particular, therapies which have demonstrated an overall survival benefit in
heavily pre-treated patients. The advent of eribulin will be welcomed by
patients and doctors across the country."

Breast cancer is the most common cancer in Czech women and accounts for nearly
25% of all newly diagnosed malignancies in the female population. ^[2]  More
than 6,400 people are diagnosed with breast cancer each year in the Czech
Republic ^[3]  and metastatic disease will develop in approximately 30% of
cases.

"Metastatic breast cancer continues to affect many women across Europe. We are
pleased that the Czech health authorities recognise the innovative drug status
and clinical value eribulin may offer to women with locally advanced or
metastatic breast cancer," commented MUDr, Miloš Živanský, Medical Director of
CEE in Eisai. "The reimbursement in the Czech Republic underscores the
potential importance of this treatment and Eisai will work closely with local
health authorities to ensure that women in the Czech Republic have rapid
access to a treatment that has a proven overall survival benefit."

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). ^[4]  Updated data
confirmed 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). ^[4] 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). ^[4]

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. ^[4]

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.

Global Phase III Clinical Study 305 (EMBRACE) ^[ ^4]

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. ^[5],[6]
Metastatic disease is an advanced stage of the disease that occurs when cancer
spreads beyond the breast to other parts of the body.

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. SPC Halaven (updated August 2013). Available at:
http://www.medicines.org.uk/emc/medicine/24382 . Last accessed October 2013

2. Epidemiology of breast cancer in the Czech Republic. Mamo.cz. 
http://www.mamo.cz/index-en.php?pg=professionals--breast-cancer-epidemiology
 Last accessed November 2013

3. Globocan 2008 statistics  http://globocan.iarc.fr/factsheet.asp  Last
accessed October 2013

4. 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

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

6. 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 November 2013.

Date of preparation: December 2013        

Job code: Halaven-UK0227

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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