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Halaven® (eribulin) Receives Registration in South Africa for Treatment of Women With Advanced Breast Cancer

Mittwoch, 30.11.2016 19:01 von PR Newswire

PR Newswire

JOHANNESBURG and HATFIELD, England, December 1, 2016 /PRNewswire/ --


Collaboration between Eisai and Clinigen provides women in South Africa with access to eribulin for advanced breast cancer   

Halaven® (eribulin) is now registered by the Medicines Control Council (MCC) in South Africa for the treatment of women with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. Eribulin was discovered and developed by Eisai and will be available to people in South Africa through a partnership with Equity Pharma, part of Clinigen's Link Healthcare division.

Approximately 7,000 women are diagnosed with breast cancer in South Africa each year.[1] Eribulin monotherapy is indicated for the treatment of patients 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 unless patients were not suitable for these treatments.[2]

"This is the first distribution agreement of this kind for Clinigen following our acquisition of Link Healthcare in 2015, and marks the continuation of a successful relationship with Eisai. As partners in the distribution of eribulin, we can leverage our comprehensive South African distribution network and local expertise to deliver this important medicine to eligible women across the country, marking an important moment in the fight against advanced breast cancer in the region," comments Shaun Chilton, Group Chief Executive Officer, Clinigen.

"Through our close partnership with Clinigen South Africa, Eisai will officially enter the South African market with the launch of eribulin and together we strive to make a meaningful difference to the lives of patients with advanced breast cancer," comments Gary Hendler, Chairman and CEO EMEA & Global Chief Commercial Officer, Oncology Business Group, Eisai.

Eisai is dedicated to the discovery, development and production of 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 to better understand the needs of patients and their families to increase the benefits health care provides.

Notes to Editors   

Halaven® (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.

Eribulin is indicated in the European Union for the treatment of adults with locally advanced or metastatic breast cancer who have received at least one chemotherapeutic regimen for advanced disease in the European Union. 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. Eribulin is also indicated in the European Union for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

Metastatic Breast Cancer  

On the continent of Africa, more than 92,600 women are diagnosed with breast cancer each year of whom around 30% subsequent develop metastatic disease.[3],[4] At this advanced stage, the cancer spreads beyond the breast to other parts of the body.

About the EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice Versus Eribulin) study[5]

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 MBC 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.

EMBRACE showed eribulin can prolong median overall survival in people (n=508) with MBC compared to people who received 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 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.

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. 

About Clinigen Group  

Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and services company with a unique combination of businesses focused on providing access to medicines. Its mission is to deliver the right medicine to the right patient at the right time.

The Group consists of five synergistic businesses focused in three areas of global medicine supply; clinical trial, unlicensed and licensed medicines.

Clinigen Clinical Trial Services is the global market leader in the management and supply of commercial medicines for clinical trials.

The Group is also the trusted global leader in ethically sourcing and supplying unlicensed medicines to hospital pharmacists and physicians for patients with a high unmet need, through three of its divisions: Idis Managed Access runs early access programs for innovative new medicines. Idis Global Access and Link Healthcare work directly with healthcare professionals to enable compliant access to unlicensed medicines on a global basis and niche essential licensed and generic medicines across Australasia, Africa and Asia (AAA region).

Clinigen Specialty Pharmaceuticals acquires global rights, revitalises and markets its own portfolio of niche hospital commercial products.

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1. CANSA. 2011 National Cancer Registry; Available at: Accessed December 2016 

2. RSA SMC Halaven (updated December 2016) 

3. Jemal A. Bray F, Forman D, et al. Cancer burden in Africa and opportunities for prevention. Cancer,

4. O'Shaughnessy J. Extending survival with Chemotherapy in Metastatic Breast Cancer, The Oncologist, 2005;10:20-29. 

5. Cortes J, O'Shaughnessy J, 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 

December 2016