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 info@equitypharma.co.za
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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