Halaven® (eribulin), the First and Only Single-agent Treatment to Extend Survival in Later Stage Metastatic Breast Cancer, Launches in Russia

HATFIELD, England, September 12, 2013 /PRNewswire/ --



Halaven^® (eribulin) is now available in Russia as a novel treatment for patients with 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] 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]

In Russia, breast cancer is the most common cause of death in women aged 45 - 55 years, having increased by 64% over the last 20 years alone. Additionally, approximately 50,000 Russian women are newly diagnosed with breast cancer each year with approximately one in every eight women at risk of developing the disease.^[3]

"This is a significant step forward for women affected by breast cancer. The development of medical therapy over the last decade has ensured the significant increase in the life expectancy of patients. However, a new medicine means further prospects for effective treatment," commented prof. Vera Gorbunova, MD, head of the chemical therapy department at the Russian Blokhin Oncologic Research Centre. "The use of eribulin in Russia will introduce new treatments and provide women with metastatic breast cancer with an opportunity to use the new medicine to achieve and maintain remission of the disease, which means that women will be able to spend more time with their family and loved ones."

"The rate of metastatic breast cancer in Russia continues to increase at an alarming rate. We are delighted that the Russian Ministry of Health recognises the clinical value Halaven offers women with locally advanced or metastatic breast cancer," commented Gary Hendler, President and CEO, Eisai EMEA. "Eisai is committed to provide effective treatment options to women in Russia with advanced breast cancer, in addition to the 500 million patients worldwide in need of alternate treatment options. The approval today further validates our human health care (hhc) mission, to satisfy unmet medical needs and contribute to the health and well-being of people around the world."

Results from the pivotal Phase III study, EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice (TPC) Versus Eribulin E7389) showed that patients treated with eribulin survived a median of 2.5 months longer than patients who received (eribulin 13.1 months vs. TPC 10.6 months, HR 0.81 (95% CI 0.66, 0.99) p=0.041).^[2] An updated analysis demonstrated that patients treated with eribulin survived a median of 2.7 months longer than patients who received TPC (overall survival of 13.2 months versus 10.5 months, respectively, HR 0.81 (95% CI 0.067, 0.96), nominal p=0.014).^[2] TPC represents active treatment options currently used by doctors in real world clinical practice.

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.^[2]

Eribulin received European Commission approval on 17 March 2011 based on the results of the Phase III EMBRACE study. Eribulin is now available in 50 countries worldwide.

Eisai is committed to developing and delivering highly beneficial new treatments to help improve the lives of people with metastatic breast 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 (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.

In the Phase III 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). Updated data from the pivotal Phase III EMBRACE trial confirmed these results, showing 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).

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.

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 recently expandedKnowledge Centre in Hatfield, UK, which now includes an additional high potency, global packaging capability, 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, Russia, the Netherlands, Belgium, and the Middle East.

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

References

1. SPC Halaven (updated April 2013). Available at: http://www.medicines.org.uk/emc/medicine/24382. Last accessed July 2013.

2. 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

3. Women's Health Empowerment Program Moscow and Central Russia. http://www.hsph.harvard.edu/breastandhealth/files/ekaterina_bashta.pdf. Last accessed September 2013

Date of preparation: September 2013

Job code: Halaven-UK0204