Halaven® (eribulin) launches in South Africa

28 February 2017

RNS Reach

Halaven® (eribulin) launches in South Africa for the treatment of women with advanced breast cancer

Eisai and Clinigen enter partnership to provide eribulin in South Africa for women with advanced breast cancer

Halaven® (eribulin) is now available in South Africa for the treatment of women with locally advanced or metastatic breast cancer who have received at least two chemotherapeutic regimens for their advanced disease. Prior therapy should have included an anthracycline and a taxane, unless patients were not suitable for these treatments1.

Approximately 7,000 women are diagnosed with breast cancer in South Africa each year and 30% will develop recurrent advanced or metastatic disease2. Metastatic breast cancer is deemed incurable and only one third of women with metastatic breast cancer will be alive five years after diagnosis2.

Shaun Chilton, Group Chief Executive Officer, Clinigen, said:

"This is the first distribution agreement of its kind for Clinigen following our acquisition of Link Healthcare in 2015, and provides access to eribulin in South Africa. This launch builds on our strong relationship with Eisai allowing us to further demonstrate our local distribution knowledge and expertise."

Gary Hendler, Chief Commercial Officer Oncology Business Group, Chairman and CEO EMEA, Eisai, said:

"We are excited and pleased to launch eribulin to South Africa for patients with advanced breast cancer. Eisai discovered and developed eribulin, and have partnered with Equity Pharma from Clinigen Group's Link Healthcare division to introduce eribulin in South Africa. We hope that this launch will make a meaningful difference to the lives of patients and their families."

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Notes to Editors

Halaven® (eribulin mesilate)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 disease3.

About the EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice Versus Eribulin) studyIn the EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice Versus Eribulin) trial4, eribulin prolonged median overall survival in people (n=762) with metastatic breast cancer compared to an alternative treatment of physician's choice by 2.5 months (13.1 vs 10.6 HR 0.81 (95% CI 0.66, 0.99) p=0.041)4. 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 constipation4.

About Clinigen GroupClinigen 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 programmes 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.

For more information, please visit www.clinigengroup.com

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.

1 Precribing Information, Halaven in South Africa

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

3 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

4 SPC Halaven (updated August 2016). Available at: http://www.medicines.org.uk/emc/medicine/24382 Accessed: October 2016