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

Hatfield, England (ots/PRNewswire) -

Halaven(R) (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, Milos Zivanský, 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(R) (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. h
ttp://www.mamo.cz/index-en.php?pg=professionals--breast-cancer-epidem
iology 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/inciden
ce/#world [http://www.cancerresearchuk.org/cancer-info/cancerstats/ty
pes/breast/incidence ]. Last accessed November 2013.

Date of preparation: December 2013

Job code: Halaven-UK0227

ots Originaltext: Eisai Europe Limited
Im Internet recherchierbar: http://www.presseportal.de

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