Eisai Europe Limited

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.asp?uno=250#KEY Last
          accessed November 2011
        4) Launois R et al. PharmacoEconomics 1997: 11(5): 495-497
        5) Eisai. Data on file 

Contact:

Media Enquiries: Eisai Europe Ltd, Charlotte Andrews / Cressida
Robson, +44(0)7947-231513 / +44(0)790-831-4155,
charlotte_andrews@eisai.net
/ cressida_robson@eisai.net ; Tonic Life Communications, Benjamyn Tan
/
Leah Peyton, +44(0)207-798-9262 / +44(0)7788-191434,
benjamyn.tan@toniclc.com / eisaioncology@toniclc.com


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