The first point-of-care for many patients with severe malaria is a community-level healthcare worker (CHW) or primary care facility. These critically ill patients should be treated as quickly as possible with injectable artesunate; however, local health posts may not have this drug or trained personnel to administer it. In such cases, WHO recommends the use of rectal artesunate (RAS) as a pre-referral intervention; this option can substantially reduce the risk of death or disability, buying time for patients to be referred to centres that can provide recommended treatment.1 However, no WHO-prequalified version of RAS exists, leaving malaria-control programmes and donors without a quality-assured option.
With funding from UNITAID, MMV is working with two Indian pharmaceutical companies, Cipla Limited and Strides Arcolab Limited, to develop RAS for submission to WHO prequalification by the end of 2015 and market introduction in 2016. This process will build on clinical studies led by WHO-TDR, which demonstrated the benefits of RAS.2
MMV has also conducted qualitative research in 20 high-burden malaria countries in subSaharan Africa to understand the need, barriers to use and potential market demand for a pre-referral severe malaria intervention. The research revealed which countries are best placed to integrate the product after its prequalification.
Dr Yusuf Hamied CEO of Cipla Limited, talks about getting involved in developing an RAS product and why they chose to work with MMV.
1. What motivated Cipla to get involved in the development of rectal artesunate?
Cipla has been manufacturing antimalarial drugs since its inception in 1935. We believe that we are among the largest producers in the world of artesunate and artemether, two of the key medicines to treat malaria today. We are also in the process of producing injectable artesunate. Two years ago, we were asked to consider making rectal artesunate as well. We already have an approved facility for making rectocaps and as they have been shown to save lives, for us this project is a priority.
2. Why did you choose to partner with MMV on this project?
MMV is extremely well known for its expertise in malaria and Cipla has been wanting to work with MMV for a very long time. We hope this project will lead to further projects in the area.
Mr Mohan Kumar CEO of Strides Arcolab Limited, explains how Strides will make a prequalified product widely available and what it is like to work with MMV.
1. What key lessons can Strides bring to ensure RAS becomes more widely available?
Strides has a distribution network in 25 countries across the African region. We have 250 medical representatives and field staff overseeing operations in these countries. Our established presence will accelerate access to the product for patients, once it is prequalified.
2. What’s different about this project compared to other development projects in Strides’ portfolio?
This project allows us to play an integral role in saving the lives of children who are critically ill with malaria. Working with MMV has been a privilege for Strides and we really value the partnership. The technical expertise and experience MMV has in bringing a product to market in the malaria field makes this an ideal partnership.
2. WHO-TDR: World Health Organization Special Programme for Research and Training in Tropical Diseases.