Medicines for Malaria Venture (MMV), a leading product development partnership in the field of antimalarial drug research and development, has signed collaboration agreements with Cipla and Strides Arcolab for the development of rectal artesunante for pre-referral treatment of children with severe malaria. The goal is to achieve WHO-prequalification of a rectal artesunate product by 2016.
The collaborations, established under the MMV-led “Improving severe malaria outcomes” project funded by UNITAID, aim to develop a rectal artesunate product for submission to WHO pre-qualification. 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 WHO.
Dr David Reddy, MMV's chief executive officer, said, This is a significant milestone in our project to improve severe malaria outcomes. 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.”
Subhanu Saxena, MD & Global chief executive officer, of Cipla, 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.”
Mohan Kumar, chief executive officer, Strides Arcolab, said, “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.”
According to WHO, World Malaria Report 2013, an estimated 5.6 million cases of severe malaria each year result in around 6.25 lakh deaths, mostly of children under 5 years. Severe malaria is the result of inadequately treated uncomplicated malaria and can quickly lead to death.
Although the WHO guidelines for the treatment of malaria recommend use of rectal artesunate, 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 treatment.
Managing the largest portfolio of antimalarial R&D projects ever assembled, of over 65 projects, MMV has seven new drugs in clinical development addressing unmet medical needs in malaria, including medicines for children, pregnant women and relapsing malaria, and drugs that could support the elimination/eradication agenda. MMV's has strong partnership network of over 300 pharmaceutical, academic and endemic-country partners in 50 countries.