WHO Pre-Qualified IV Artesunate may Bring Brighter Future for Treatment of Severe Malaria for Ghana

THE LANCET published a clinical result named African Quinine Artesunate Malaria Trial ?AQUAMAT?on its website on Nov 8, 2010. The AQUAMAT, which was sponsored by the University of Oxford, funded by The Wellcome Trust (UK) and supported by MMV ( Medicines for Malaria Venture), 5425 children enrolled, was done in 11 centers in 9 countries across Africa (Mozambique, The Gambia, Ghana, Kenya, Tanzania, Nigeria, Uganda, Rwanda and Democratic Republic of Congo) from October 2005 to July 2010.

Prof. Nicholas J White, the lead author of this trial said that the result of the trial was exciting: Following artesunate treatment 8.5% (230/2712) of the patients died compared with 10.9% (297/2713) following quinine, an odds ratio stratified for study site of 0.75 (95%CI 0.63 to 0.90), and a relative reduction of 22.5% (95% CI 8.1 to 36.9%, p=0.0022). This article states that “Artesunate substantially reduces mortality in African children with severe malaria. These data, together with a meta-analysis of all trials comparing artesunate and quinine, strongly suggest that parenteral artesunate should replace quinine as the treatment of choice for severe falciparum malaria worldwide.”

The authors complained in the articles that “The major factor restricting the deployment of artesunate has been unavailability of a product satisfying international good manufacturing standards”. Just three (3) days before the publication of this article, Guilin Pharmaceutical Co. Ltd, the supplier of the artesunate for injection for the AQUAMAT study, received news that The WHO Prequalification Programme had added Artesunate 60mg powder for injection, manufactured by Guilin, to its prequalified list.

According to the article, “If 4 million African children with severe malaria every year were to receive prompt treatment with parenteral artesunate instead of quinine, and the benefits were similar to those recorded in this trial, then approximately 100, 000 lives might be saved per year.”

Guilin Pharmaceutical Co., Ltd (Guilin) introduced its artesunate powder for injection in Ghana in 2009 with generic name “Artesuante for injection”. Currently, Guilin has applied for the registration of three different strengths of artesunate powder for injection 30mg, 60mg and 120mg under the proprietary name Glunate® and these products are expected to be launched in Ghana at the beginning of 2011 when the registration processes would have been completed.

Besides Artesunate for injection, Guilin has introduced WHO prequalified AS+AQ (AMFm products) and other antimalarial drugs and devices. “I hope IV artesunate will bring brighter future for treatment of severe malaria for Ghana. We will do our best to help Ghana to offer the best treatment for malaria”, said Mr. Song Liujun, the managing director of Guilin Pharmaceutical (Ghana) Limited.  

The following links provide you with more information on the clinical trial and PQ.   
http://apps.who.int/prequal/
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)61924-1/abstract
http://www.mmv.org/newsroom/news/mmv-supported-iv-artesunate-receives-who-prequalification

Guilin Pharmaceutical Co., Limited is a subsidiary of Fosun Pharmaceutical (Group) Co., Ltd., one of the largest pharmaceutical companies in China. Guilin is one of the six (6) WHO prequalified companies for the manufacture of ACTs and also the first Chinese pharmaceutical company approved by WHO’s GMP.  The company is the innovator of Artesunate tablets and injection and currently the United States Pharmacopeia (USP) has accepted the company’s reference standards of Artesunate Tablets. The company supplies ACTs to WHO, UNICEF and other international agencies as well as over 40 countries.

You may contact the following address in Ghana for any further information.

Manufacturer:
Guilin Pharmaceutical Co., Ltd.
Local Branch:
Guilin Pharmaceutical (Ghana) Limited
House No. 5, Osu Badu Street,
Airport West Residential, ccra, Ghana
P. O. Box: KPMB 58, Airport, Accra.
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it This e-mail address is being protected from spambots. You need JavaScript enabled to view it ; This e-mail address is being protected from spambots. You need JavaScript enabled to view it This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Tel: 0302765915
Mob: 054 7753455/6
Website: www.guilinpharma.com; www.fosunpharma.com