Life-extending Advanced Breast Cancer Treatment Halaven® (Eribulin Mesylate) Launched in Kingdom of Saudi Arabia

HATFIELD, England, February 26, 2015 /PRNewswire/ --

 - For EMEA media only: not for Swiss/U.S. Journalists

Innovative breast cancer treatment Halaven^® (eribulin mesylate) has recently been approved by the Saudi Food and Drug Authority (SFDA) for the treatment of women with advanced disease. Specifically, it is indicated for the treatment of patients with locally advanced or metastatic breast cancer (MBC) who have received at least two chemotherapeutic regimens for advanced disease. 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 only single agent chemotherapy proven to improve significantly median overall survival in metastatic breast cancer after treatment with an anthracycline and taxane.^[2] Developed and manufactured by Eisai, the therapy will be marketed in Saudi Arabia by the company's regional partner NewBridge Pharmaceuticals.  

"The availability of Eribulin is an important step forward for patients in Saudi Arabia with advanced breast cancer. Patients with advanced breast cancer are in real medical need of new treatment modalities, and in particular, therapies, like Eribulin, which have demonstrated an overall survival benefit. The availability of Eribulin will be welcomed by patients and doctors across the country," commented Dr. OmalKhair Abulkhair, Section Head and Oncology consultant in King Abdulaziz medical city.

There were an estimated 2,700 diagnosed cases of breast cancer in Saudi Arabia in 2012 with almost 800 deaths from the disease.^[3] Breast cancer is the most common cancer among women in Saudi Arabia.^[4]

"Breast cancer is a major health issue in Saudi Arabia and new treatment options for patients with advanced disease are needed now more than ever. We are pleased that the Saudi Arabian health authorities recognise the innovative drug status and clinical value eribulin offers. Along with our regional partner NewBridge, Eisai will work to ensure that patients in the country have easy access to this innovative treatment with proven overall survival benefit," said Gary Hendler, President and CEO, Eisai EMEA, and President, Eisai Oncology Global Business Unit.

Eisai is dedicated to discovering, developing and producing innovative oncology therapies that can make a difference and impact the lives of women 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^® (eribulin mesylate) 

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.

Eribulin is currently indicated for the treatment of women with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. 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.

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.

In the total phase III EMBRACE study population, eribulin was shown to prolong median overall survival in heavily pre-treated women with metastatic breast cancer compared to women receiving TPC by 2.7 months (13.2 vs 10.5 HR 0.81 (95% CI 0.67, 0.96) nominal p=0.014). A pre-planned analysis of participants 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 people 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 women involved in the EMBRACE trial. Neutropenia only led to eribulin discontinuation for 0.6%. 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.

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 pharmaceuticals, biologics, and medical diagnostics serving the AfMET markets (Middle East, Africa, Turkey) to address the unmet medical needs of diseases with high regional prevalence. Headquartered in UAE with strong local and international business network, NewBridge is 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 Burrill & Company, Venture Capital, private equity, merchant banking and media; KLSC the life sciences arm of National Technology Enterprises Company (NTEC) and Elan Corporation plc, a biotechnology company.

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

References  

1. Saudi Food and Drug Authority Registration Certificate for Halaven received November 2014

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. IARC. GLOBOCAN 2012. Available at: http://globocan.iarc.fr/Pages/fact_sheets_population.aspx . Last accessed February 2015

4. Saudi Arabian Ministry of Health. Available at: http://www.moh.gov.sa/en/HealthAwareness/Campaigns/Breastcancer/Pages/stat.aspx . Last accessed February 2015

Date of preparation: February 2015       

Job code: Halaven-UK0304