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1 December 2016
RNS Reach
Halaven® (eribulin) receives registration in South Africa for
treatment of women with advanced breast cancer
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
Shaun Chilton, Group Chief Executive Officer, Clinigen, said:
"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.”
Gary Hendler, Chairman and CEO EMEA & Global Chief Commercial Officer, Oncology Business Group, Eisai,
said:
“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.”
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.
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Contact details
Clinigen Group plc
Shaun Chilton, Chief Executive Officer
Tel: +44 (0) 1283 495010
Numis Securities Limited
Michael Meade / Freddie Barnfield (Nominated Adviser)
James Black / Tom Ballard (Corporate Broking)
Tel: +44 (0) 20 7260 1000
Peel Hunt LLP - Joint Broker
Tel: +44 (0) 20 7418 8900
James Steel / Dr Christopher Golden
Instinctif Partners (media – Clinigen)
Tel: +44 (0) 20 7457 2020
Melanie Toyne-Sewell / Jen Lewis / Jayne Crook
Email: [email protected]
Eisai Europe Ltd
Tel: +44 (0) 7908 314 155
Cressida Robson
Email: [email protected]
Tonic Life Communications (media – Eisai)
Tel: +44 (0) 7720 496 472
Alex Davies
Email: [email protected]
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) study5
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 singleagent 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
2
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 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.
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.
CANSA. 2011 National Cancer Registry; Available at: http://www.cansa.org.za/files/2016/08/NCR-2011-cancer-tables.pdf
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,
2012;118:4372-84.
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
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