Collaborations set to advance life-saving pre-referral intervention for severe malaria
MMV signs collaboration agreements with two Indian pharmaceutical companies, Cipla Limited and Strides Arcolab Limited for the development of rectal artesunate, a pre-referral intervention for children with severe malaria.
The collaborations, established under the MMV-led "Improving Severe Malaria Outcomes" project funded by UNITAID1, aim to develop a rectal artesunate product for submission to WHO prequalification. Cipla and Strides will each develop a product building on the clinical studies led by TDR, the Special Programme for Research and Training in Tropical Diseases hosted by the World Health Organization.
The goal is to achieve WHO-prequalification of a rectal artesunate product by 2016.
An estimated 5.6 million cases of severe malaria each year result in around 627,000 deaths, mostly of children under 5.2 Severe malaria is the result of inadequately treated uncomplicated malaria and can quickly lead to death.
A WHO-TDR trial conducted in 17,000 patients in Bangladesh, Ghana and Tanzania demonstrated that "if patients with severe malaria cannot be treated orally and access to injections will take several hours, a single inexpensive artesunate suppository at the time of referral substantially reduces the risk of death or permanent disability."3
Although the WHO guidelines for the treatment of malaria recommend use of rectal artesunate,4 there is currently no product with WHO prequalification or marketing authorisation by a stringent regulatory authority. This prevents international donors from funding the procurement of this potentially life-saving intervention.
“This is a significant milestone in our project to improve severe malaria outcomes,” said Dr David Reddy, MMV’s CEO. “We have agreed a clear pathway with these two manufacturers to bring this product to an internationally acceptable quality standard. This will help make the product available to more patients, buying more time and saving more lives. We look forward to working closely with Cipla and Strides and thank UNITAID for supporting these efforts.”
Mr Subhanu Saxena, MD & Global CEO, Cipla Limited said: “We are happy to join hands with MMV that shares our ongoing commitment to fight against malaria. Cipla is one of the major suppliers of antimalarial products worldwide and we have designed many innovative medicines for children in developing countries. Through this collaboration, we will endeavour to make rectal artesunate accessible to each and every child with severe malaria in a pre-referral setting in malaria-endemic countries.”
“We are excited to be part of this initiative, as it will expand access to quality, affordable medicines for a wider population and save more lives,” said Mohan Kumar, CEO, Strides Arcolab Limited.
1. UNITAID invests to increase availability to better and more affordable products to prevent, test and treat HIV/AIDS, tuberculosis and malaria in developing countries. It was launched in 2006 by Brazil, Chile, France, Norway and the United Kingdom. UNITAID is hosted by the World Health Organization and is currently supported by 17 contributing members.
3. Gomes MF et al. Pre-referral rectal artesunate to prevent death and disability in severe malaria: a placebo-controlled trial. Lancet. 373(9663):557-66 (2009).
4. World Health Organization. Guidelines for the treatment of malaria. Second edition , March 2010.