New Breast Cancer Treatment Available in France

Hatfield, England (ots/PRNewswire) -

Reimbursement granted for Halaven(R) (eribulin) for women with
locally advanced or metastatic breast cancer

Halaven(R) (eribulin), a novel treatment for patients with locally
advanced or metastatic breast cancer who have progressed after at
least two chemotherapeutic regimens for advanced disease, has today
received reimbursement approval from the French health authorities.
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 in patients with heavily
pre-treated advanced breast cancer, compared to other single agent
chemotherapies.[2]

Breast cancer is the most common cancer amongst women in France,
accounting for 35.5% of all cancers[3] and has the highest mortality
rate of all cancers in France. Information on French cancer
statistics from The Fédération Nationale des Centres de Lutte Contre
le Cancer, estimate that there are approximately 13,400 new cases of
metastatic breast cancer every year in France.[4] It is estimated
that up to 7,400 patients will be able to benefit from eribulin per
year in France, and the new drug is already being used in a number of
key cancer treatment institutions.[5]

Dr Joseph Gligorov from Tenon Hospital APHP, Paris, France
commented; "From my clinical experience of eribulin to date, this
drug is a promising treatment option for women with heavily
pre-treated breast cancer. I have treated many women with eribulin
who have had a good experience, not only regarding the efficacy but
also the side effect profile that is expected and manageable."

"It is really encouraging to see that the French health
authorities recognise the innovative drug status and clinical value
eribulin may offer to women with locally advanced or metastatic
breast cancer. The approval for reimbursement in France underscores
the potential importance of this treatment and it is a positive step
forward for women affected by this disease. Patients who are eligible
may now benefit from a novel treatment that may extend their lives, a
notion that had until now been deemed unrealistic," commented Evelyne
Lepetit, Oncology Business Unit Head for France, Eisai Europe.

In addition to the French authorities granting reimbursement for
the use of eribulin in heavily pretreated women with metastatic
breast cancer, Eisai announces it is expanding its footing in the
Israeli market with the registration grant of eribulin.

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.

Eribulin received European Commission approval on 17 March 2011
based on the results of the Phase III EMBRACE study. Eribulin is
approved in the European Union, USA, Switzerland, Japan, and
Singapore. In Europe, eribulin is currently commercially available in
Austria, Denmark, Estonia, France, Finland, Germany, Iceland,
Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Poland,
Sweden, Switzerland, and the United Kingdom.

Global Phase III Clinical Study (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.[2]

In the total Phase III EMBRACE study population, eribulin was
shown to prolong overall survival in heavily pre-treated patients
with metastatic breast cancer compared to patients receiving TPC by
2.5 months compared to patients receiving TPC (eribulin 13.1 months
vs. TPC 10.6 months p=0.014).[1,2] An updated analysis, demonstrated
a statistically significant improvement of 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 overall
survival benefit of eribulin over TPC of 3.0 months (nominal
p=0.031).[2]

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 (neutropenia), 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. Neutropenia 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.[2]

Eisai in Oncology

Eisai is dedicated to discovering, developing and producing
innovative oncology therapies that can make a difference and impact
the lives of patients 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. 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 R&D-based pharmaceutical
companies and has defined its 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
recently expanded their UK Hatfield facility which now supports the
company's growing European, Middle Eastern, African and Russian
(EMEA) business.

Eisai concentrates its R&D activities in three key areas:

- Neuroscience, including: Alzheimer's disease, multiple 
sclerosis,
          neuropathic pain, epilepsy, depression
        - Oncology including: anticancer therapies; tumour 
regression, tumour
          suppression, antibodies, etc and supportive cancer 
therapies; pain relief, nausea
        - Vascular/Immunological reaction including: acute coronary 
syndrome,
          atherothrombotic disease, rheumatoid arthritis, psoriasis, 
Crohn's disease

With operations in the U.S., Asia, Europe and its domestic home
market of Japan, Eisai employs more than 11,000 people worldwide. In
Europe, Eisai undertakes sales and marketing operations in over 20
markets, including the United Kingdom, France, Germany, Italy, Spain,
Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway,
Portugal, Iceland, Czech Republic, Slovakia, the Netherlands,
Belgium, Luxembourg, the Middle East and Russia.

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

References

1) SPC Halaven (updated March 2011). Available at:
          http://www.medicines.org.uk/EMC/medicine/24382/SPC/Halaven+
0.44+mg+ml+solution+for+injection
          . Last accessed October 2011
        2) Cortes J et al. The Lancet. 2011; 377: 914-923
        3) GLOBOCAN. 2008. Breast Cancer in France. Available at:
          http://globocan.iarc.fr/factsheets/populations/factsheet.as
p?uno=250#KEY Last
          accessed November 2011
        4) Launois R et al. PharmacoEconomics 1997: 11(5): 495-497
        5) Eisai. Data on file

Rückfragehinweis:
Media Enquiries: Eisai Europe Ltd, Charlotte Andrews / Cressida
Robson, +44(0)7947-231513 / +44(0)790-831-4155,
[email protected]
/ [email protected] ; Tonic Life Communications, Benjamyn Tan
/
Leah Peyton, +44(0)207-798-9262 / +44(0)7788-191434,
[email protected] / [email protected]

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