Clinigen extends agreement with Eisai to supply Halaven®, Fycompa® and Lenvima® into 10 African countries

All three medicines will be submitted for registration in Namibia, Botswana, Zimbabwe, Zambia, Ghana, Nigeria, Kenya, Uganda and Tanzania, subject to local regulatory approval

BURTON-ON-TRENT, United Kingdom, January 3, 2018/ -- Clinigen Group plc (AIM: CLIN, ‘Clinigen’) (www.ClinigenGroup.com), the global pharmaceutical and services company, has extended its exclusive agreement with Eisai Europe Ltd. (www.Eisai.com) to obtain the marketing authorisation and subsequently launch Halaven® (eribulin), Fycompa® (perampanel) and Lenvima® (lenvatinib) into 10 African countries.

The new agreement follows the successful launch of Halaven and Fycompa in South Africa in February and July 2017 respectively. All three medicines will be submitted for registration in Namibia, Botswana, Zimbabwe, Zambia, Ghana, Nigeria, Kenya, Uganda and Tanzania, subject to local regulatory approval.

Eribulin is currently licensed in South Africa only for the treatment of women with locally advanced or metastatic breast cancer who have received at least two chemotherapeutic regimens for their disease. These would usually include an anthracycline and taxane, unless not suitable. In 2012, breast cancer was the leading cancer among the female population in the majority of countries in Africa[1] and is responsible for one in four diagnosed cancers and one in five cancer deaths in women[2] worldwide.

Perampanel is currently licensed in South Africa only for the adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older. Across Africa, the prevalence of epilepsy varies between 2.2 to 58 cases per 1000 people, with an average prevalence of 15.8 per 1000[3]. The World Health Organisation estimates that in Africa, epilepsy directly affects 10 million people[4].

Lenvatinib is not currently registered in any of the 10 countries. In Europe, lenvatinib is licensed for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated thyroid carcinoma (DTC), refractory to radioactive iodine. DTC is the most common form of thyroid cancer. Overall annual incidence globally is about 1/10,000, and the incidence appears to be increasing[5].

Healthcare professionals can obtain details about any of the medicines mentioned above by emailing Info@EquityPharma.co.za

Benjamin Miny, Managing Director, South Africa, Clinigen, said:

“This agreement builds on the strong partnership we have with Eisai in providing access to medicines.”

“We are able to leverage our extensive distribution network in the region and local expertise to enable access to these important medicines, helping to address the unmet medical needs of patients and their families across southern Africa.”

Distributed by APO Group on behalf of Clinigen Group plc.



Contact details
Clinigen Group plc
Tel: +44 (0) 1283 495010 / +27 12 345 1747
Shaun Chilton, Group Chief Executive Officer
Benjamin Miny, Managing Director, South Africa

Numis Securities Limited
Tel: +44 (0) 20 7260 1000
Michael Meade / Freddie Barnfield (Nominated Adviser)
James Black / Tom Ballard (Corporate Broking)

RBC Capital Markets - Joint Broker
Tel: +44 (0) 20 7653 4000
Marcus Jackson / Elliot Thomas / Jack Wood

Instinctif Partners
Melanie Toyne-Sewell / Alex Shaw
Tel: +44 (0) 20 7457 2020
Email: Clinigen@Instinctif.com

About Clinigen Group
Clinigen Group plc (AIM: CLIN) (www.ClinigenGroup.com) is a global pharmaceutical and services company with a unique combination of businesses focused on providing ethical access to medicines. Its mission is to deliver the right medicine to the right patient at the right time through three areas of global medicine supply; clinical trial, unlicensed and licensed medicines. Clinigen acquired Quantum Pharma in November 2017.

For more information, please visit www.ClinigenGroup.com

Fycompa® (perampanel)
Perampanel is a first-in-class, non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate receptor antagonist on post-synaptic neurons. AMPA receptors, widely present in almost all excitatory neurons, transmit signals stimulated by the excitatory neurotransmitter glutamate within the brain, and are believed to play a role in central nervous system diseases characterised by excess neuroexcitatory signalling, including epilepsy[6].

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.

Lenvima® (lenvatinib)
Lenvatinib, discovered and developed by Eisai, is an oral multikinase inhibitor of vascular endothelial growth factor receptor 1–3, fibroblast growth factor receptor 1–4, platelet-derived growth factor receptor–alpha, and RET and KIT proto-oncogenes[7, 8].

About Eisai Co., Ltd.
Eisai Co., Ltd. (www.Eisai.com) 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 info on Eisai please visit www.Eisai.com. 

References
[1] Kantelhardt EJ, Cubasch H, Hanson C. Taking on breast cancer in East Africa: global challenges in breast cancer. Curr Opin Obstet Gynecol. 2015;27:108–14.
[2] Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010; 127:2893–917.
[3] Shakirullah et.al. The Prevalence, Incidence and Etiology of Epilepsy. International Journal of Clinical and Experimental Neurology, 2014, Vol. 2, No. 2, 29-39.
[4] http://APO.af/ZERbjv.
[5] Carlo Cappelli, et. al. TSH Variability of Patients Affected by Differentiated Thyroid Cancer Treated with Levothyroxine Liquid Solution or Tablet Form. Int J Endocrinol. Volume 2017, Article ID 7053959.
[6] Lee K, et al. (2016) AMPA Receptors as Therapeutic Targets for Neurological Disorders. Advances in Protein Chemistry and Structural Biology. 103,203-261.
[7] Matsui J, et al. (2008) E7080, a novel inhibitor that targets multiple kinases, has potent antitumor activities against stem cell factor producing human small cell lung cancer H146, based on angiogenesis inhibition. Int J Cancer. 122:664-671.
[8] Okamoto K, et al. (2014) Distinct Binding Mode of Multikinase Inhibitor Lenvatinib Revealed by Biochemical Characterization. ACS Medicinal Chemistry Letter.

SOURCE
Clinigen Group plc