Eisai's Halaven First Breast Cancer Therapy for Which Price Negotiations with the National Association of Statutory Health Insurance Funds were Successfully Concluded

FRANKFURT and HATFIELD, England, October 15, 2012 /PRNewswire/ --

Price agreement endorses confidence in new treatment

Eisai announced today that it concluded an agreement with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) in Germany on a reimbursement price for Halaven^® (eribulin). According to its European licence Halaven^® is to be used for the treatment of patients with locally advanced or metastatic breast cancer whose disease has progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.^[1]

"We are delighted to have reached an agreement on the reimbursement price of Halaven with the GKV-SV. This is positive news as the price agreement provides confidence for payers and most importantly for physicians treating seriously ill women with metastatic or locally advanced breast cancer.  Our negotiations have provided further evidence that a balance between the interests of pharmaceutical manufacturers and health insurance funds can be met, and can help generate savings for the German healthcare system," said Georg Wager, Director Market Access, Eisai, Europe Central.

Frank Zeymer, Eisai's Oncology Business Unit Director, Central Region, added, "Halaven is already endorsed in the German guidelines and is being successfully used in clinical practice, so we believe it can be established as the standard of care for eligible patients here in Germany."

The pivotal phase III, EMBRACE study demonstrates that eribulin is the first, single-agent chemotherapy to show both a statistically significant and clinically relevant median overall survival benefit in women with heavily pre-treated advanced breast cancer (compared to treatment of physician choice).^[2] Eribulin has an expected and manageable safety profile which is in line with other single-agent chemotherapy treatments for advanced breast cancer in this setting.^[2]

Commenting on the agreement in Germany, Gary Hendler, President and CEO, Eisai EMEA & Russia explained, "Despite facing challenging economic hurdles, Eisai is committed to ensure that patients receive access to Halaven. Eisai's entry into this market is aligned with the company's wider strategy of increasing access to our medicines based on affordability, availability and adoption by making products available in new markets. We have also worked in partnership with the authorities in the UK, France, and Italy to ensure further access to Halaven for patients across Europe and more specifically in Spain, we have been collaborating with the Spanish Government and Ministry of Health to try and reach a reimbursement agreement based on the affordability of innovative medicines like Halaven."

The development and increasing patient access to eribulin underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well being of people 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.^[1] 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.

Halaven is approved in the European Union, USA, Switzerland, Japan, and Singapore. In Europe, Halaven has received pricing authorisation and been launched in Austria, Denmark, Finland, Germany, Iceland, Italy, Norway, Sweden, Switzerland, Slovenia, and the UK.

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 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 2.7 months (13.2 vs 10.5 HR 0.81 (95% CI 0.067, 0.96) nominal p=0.014).^[2] 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).

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]

Metastatic Breast Cancer

Metastatic breast cancer is an advanced stage of the disease that occurs when cancer spreads beyond the breast to other parts of the body. In Europe, approximately 6% of breast cancers are metastatic at diagnosis with a five-year survival rate of 21%.^[3]

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 recently expanded their UK Hatfield commercial, research and manufacturing facility which now supports the company's growing EMEA business.

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

• Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight loss
• Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc.
• 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 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. Summary of Product Characteristics Halaven (updated March 2011). Available at:
http://www.medicines.org.uk/EMC/medicine/24382/SPC/Halaven+0.44+mg+ml+solution+for+injection/

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 -9233. Cardoso, M. and Castiglione F. Locally recurrent or metastatic breast cancer: ESMO Clinical Recommendations for diagnosis, treatment and follow-up. On behalf of the ESMO Guidelines Working Group. Ann Oncol (2009) 20 (suppl 4): iv15-iv18

3. Cardoso, M. and Castiglione F. Locally recurrent or metastatic breast cancer: ESMO Clinical Recommendations for diagnosis, treatment and follow-up. On behalf of the ESMO Guidelines Working Group. Ann Oncol (2009) 20 (suppl 4): iv15-iv18

Date of preparation: October 2012

Job code: eribulin-UK2175