HATFIELD, England, April 22, 2015 / PRNewswire — Halaven(R) (eribulin) launches today in the United Arab Emirates (UAE) for the treatment of women with locally advanced or metastatic breast cancer (MBC). Eribulin is a life extending treatment for women with advanced disease who have progressed after at least two chemotherapeutic regimens. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.[1]

Eribulin is the first in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action. The treatment will be marketed and commercialised in the UAE by Eisai’s regional partner NewBridge Pharmaceuticals.

It is estimated that 30% of people who present with breast cancer in the UAE will develop metastatic disease.[2] Breast cancer is the most common cancer in women in the UAE[3] and accounted for 27.7% of female cancer deaths in 2012.[4]

The approval of eribulin in the UAE is based on the pivotal Phase III EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician’s Choice (TPC) Versus Eribulin E7389) study.[2]EMBRACE showed eribulin prolongs median overall survival in women with MBC compared to women receiving an alternative treatment of physician’s choice by 2.7 months (13.2 vs 10.5 HR 0.81 (95% CI 0.67, 0.96) nominal p=0.014). The most commonly reported adverse reactions in the eribulin study arm are fatigue, neutropenia, alopecia, peripheral neuropathy, nausea and constipation.[2]

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.

Notes to Editors
Halaven(R) (eribulin)
Eribulin is the first in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action. Structurally, eribulin is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Eribulin is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division.

Global Phase III Clinical Study 305 (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 women treated with eribulin versus a 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 participants 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 participants in the TPC arm received chemotherapy.

About Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. 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 our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in multiple therapeutic areas with high unmet medical needs, including Oncology and Neurology.

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit http://www.eisai.com.

About NewBridge Pharmaceuticals
NewBridge Pharmaceuticals is a specialty therapeutics company focused on in-licensing FDA and EMA approved pharmaceuticals, biologics, and molecular diagnostics serving the AfMET markets (Middle East, Africa, and Turkey) to address the unmet medical needs of diseases with high regional prevalence. NewBridge is a one-stop solution to multiple geographies and hence uniquely positioned as the partner-of-choice for companies seeking to create value for their pharma or medical products in the high growth emerging AfMET markets. NewBridge is financially backed by International, Regional and Corporate Investors.

For further information please visit: http://www.nbpharma.com

References

1. United Arab Emirates Ministry of Health. Halaven UAE license approval letter. 2015

2. Ravichandran K, et al. Population based survival of female breast cancer cases in Riyadh Region, Saudi Arabia. Asian Pacific Journal of Cancer Prevention, 2005: 6, 72-6

3. Tadmouri G, et al. Cancers in the United Arab Emirates. Genetic Disorders in the Arab World. http://www.cags.org.ae/cbc08ca.pdf. Accessed: April 2015

4. Health Statistics 2012. Health Authority Abu Dhabi. http://www.haad.ae/HAAD/LinkClick.aspx?fileticket=JY0sMXQXrOU%3d&tabid=1243. Accessed: April 2015

Date of preparation: April 2015
Job Code: Halaven-UK0407

Source: Eisai Europe Limited