Clinigen Registers Garsun® (artesunate for injection) in South Africa for the Treatment of Patients with Severe Malaria

Clinigen Group plc (AIM: CLIN, ‘Clinigen’ or the ‘Group’), the global pharmaceutical and services company, announces that it has registered Garsun® (artesunate for injection) in South Africa. Equity Pharmaceutical (Pty) Ltd, a division of Clinigen, will be the Holder of the Certificate of Registration.

Garsun® is an innovative medicine indicated for the treatment of severe malaria, specifically caused by the parasite Plasmodium falciparum, in both adults and children. It is owned by Guilin Pharma, a member of Fosun Pharma, a leading healthcare group in PR China.

Malaria is an infectious disease which is caused by mosquito-borne parasites. Malaria in South Africa is seasonal, with peaks occurring from September to May, and it is endemic in three of South Africa’s nine provinces: Limpopo, Mpumalanga and KwaZulu-Natal. In the 2016/17 malaria season, by March 2017, a total of 9,478 malaria cases and 76 deaths had been reported in South Africa compared to 6,385 malaria cases and 58 deaths in the 2015/16 season1.

The newly-registered injectable artesunate product has been available in South Africa since October 2017.

Healthcare professionals can obtain details about Garsun® (artesunate for injection) by emailing [e-mail]

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

“The conversion of unlicensed to licensed medicines is a key strategic priority for the Group. Injectable artesunate is a great example where its registration is allowing for increased access for doctors and their patients to this potentially life-saving drug.

“Our work with Guilin Pharma to achieve registration illustrates how Clinigen is increasingly becoming an attractive partner to pharmaceutical companies, both in Africa and around the world, in the supply and distribution of their products.”

Professor Lucille Blumberg, Deputy-Director: Epidemiology & Medical Consultant, Centre for Emerging and Zoonotic Diseases, said:

“The World Health Organisation strongly recommends that intravenous artesunate should be used in preference to quinine for the treatment of severe malaria in adults and children, as it reduces malaria deaths. It has been used in a special drug access programme in South Africa over the past 8 years, which has provided evidence of its rapid action, ease of administration and favourable safety profile, and supported the findings of extensive clinical studies in Asia and elsewhere in Africa.

“The registration of Garsun® is welcomed and will likely ensure a regular supply and better access of this life-saving drug for the treatment of all patients with severe malaria in South Africa.”

- Ends -

Notes to Editors

About injectable artesunate (Garsun®)

Injectable artesunate is currently the only commercialised water soluble derivatives of artemisinin. Injected intravenously*, it can save different suffering groups from encephalic malaria and other fatal malaria illnesses. Results from a number of large scale clinical trials show that injectable artesunate has a good safety profile and is effective among special groups, such as underage children. Injectable artesunate of Guilin Pharma was approved by the WHO PQ in 2010, and now is registered and marketed in 37 countries around the world. The medicine is also acceptable in the European Union, Canada and Australia through designated patient projects.

*Please refer to the registered Garsun® package insert, dated 2 June 2017, for registered indications and dosage. Equity Pharmaceuticals only recommends the use of Garsun® in accordance with the approved South African package insert.

About Clinigen Group

Clinigen Group plc (AIM: CLIN) 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.

Clinical Trial Services

Clinigen is the global market leader in the specialist supply and management of quality-assured comparator medicines and services to clinical trials and Investigator Initiated Trials.

Unlicensed Medicines

Clinigen is the global leader in ethically sourcing and supplying unlicensed medicines to hospital pharmacists and physicians for patients with a high unmet medical need. The Group manages early access programmes to innovative new medicines and provides ‘on demand’ access globally to medicines which remain unlicensed at the point of care.

Commercial Medicines

Clinigen acquires global rights to niche hospital only and critical care products, revitalising these assets around the world and returning them back to sustained growth. It also provides access to licensed and branded generic medicines in the Africa and Asia Pacific region.

The Group also has an ‘unlicensed to licensed’ strategy, where it looks to take unlicensed medicines with commercial potential and licence them, helping to address unmet medical need and allowing the Group to capitalise on its market-leading positions.

For more information on Clinigen, please visit www.clinigengroup.com

About Shanghai Fosun Pharmaceutical (Group) Co.,Ltd

Established in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196.SH, 02196.HK) is a leading healthcare Group in the PRC. Fosun Pharma strategically covers important segments of the healthcare industry value-chain, including pharmaceutical manufacturing and R&D, healthcare services, medical diagnosis, medical devices manufacturing and agent, as well as pharmaceutical distribution and retail, making contribution to improving people’s health. Fosun Pharma maintains a National Recognised Enterprise Technology Centre and a highly capable international R&D team, focusing on innovation and research of therapeutic areas including cardiovascular system, central nervous system, blood system, metabolism and digestive tract system, anti-infection and anti-tumor. With its commitment to innovation for good health and creating a better future, Fosun Pharma will continue insisting on the strategic development approach of “organic growth with external expansion and integrated business operation”, striving to be one of the first-class enterprises in the global healthcare market.

1 Limpopo Department of Health; Outbreak Division of Public Health, Surveillance and Response, NICD-NHLS.

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