Halaven® (Eribulin) Now Commercially Available in Lebanon for the Treatment of Metastatic Breast Cancer

HATFIELD, England, April 7, 2014 /PRNewswire/ --



Eisai partners with Abela Frères for the commercialisation of Halaven^® (eribulin) 

Eisai EMEA (Europe, Middle East, Africa, Russia and Oceania) today announces that Halaven^® (eribulin) is now commercially available in Lebanon as a treatment for women with locally advanced or metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.^[1] Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.^[1] Eisai will partner with Abela Frères to market eribulin in Lebanon.

Around 1,750 women in Lebanon are diagnosed with breast cancer every year, demonstrating a need for new treatment options.^[2] Eribulin has been proven to significantly extend overall survival in patients with heavily pre-treated metastatic breast cancer, compared to other single agent chemotherapies.^[3]  As one of the most dynamic pharmaceutical markets within the Arab region, Lebanon remains a leader in healthcare with one of the highest rates of Gross Domestic Product (GDP) spend on healthcare in the Middle East and North Africa regions.^[4]

Toshitaka Asano, Vice President Market Development Business Unit EMEA, commented: "The launch of Halaven in Lebanon is part of Eisai's wider strategy to establish a solid foundation in the EMEA region. Lebanon is an important market with specific healthcare needs and our valued partnership with Abela Frères will ensure that people with metastatic and locally advanced breast cancer have access to this additional and important treatment option."

"We are committed to building a strong relationship with Eisai to ensure that Halaven reaches the people who need it in Lebanon," said Antoine Fadel, Chief Executive Officer, Abela Frères. "Our extensive marketing and distribution experience in the region best positions us for this partnership."

As part of Eisai's globalisation strategy set out in its mid-term strategic plan in 2011 "HAYABUSA", the company seeks to expand its global presence by 2015 in an effort to achieve its objective of making contributions to more than 500 million patients worldwide.

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 which prevents cell division.

Global Phase III Clinical Study 305 (EMBRACE)^[3]

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 (asthaenia), 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.

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

About Abela Frères
Part of the Holcom Group of companies, Abela Frères was established in 1927 as a family owned firm importing and distributing pharmaceutical products in Lebanon and the Middle East. Through its many years of operation and experience, the key success factors of Abela Frères is its ongoing commitment to providing high integrity and excellent partnership to its suppliers with the aim to become leaders within the Healthcare Distribution Market.  Headquartered in Beirut, Lebanon, the company is a private stock company which employs 147 people.

References 

1. SPC Halaven. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002084/human_med_001427.jsp&mid=WC0b01ac058001d124. Last accessed March 2014. 

2. Ghosn M et al. The Oncologist. 2011;16(11):1552-1556 

3. Cortes J et al. The Lancet. 2011;377;914-923 

4. World Bank. Health Expenditure Data. http://data.worldbank.org/indicator/SH.XPD.TOTL.ZS/countries?display=map Last accessed March 2014.

Date of preparation: April 2014 

Job Code: Halaven-UK0226