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

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