The Global Pipeline of New Medicines for the Control and Elimination of Malaria

Melinda P Anthony; Jeremy N Burrows; Stephan Duparc; Joerg JMoehrle; Timothy NC Wells

Disclosures

Malar J. 2012;11(316) 

In This Article

Background

Recent years have seen a transformation in the landscape of malaria drug discovery and development. A review of publicly available data from PubMed, clinicaltrials.gov as well as proprietary databases, such as Thomson Pharma, revealed that as of March 2012, over 50 projects were in progress worldwide. These include a wide variety of molecules in the window between late discovery (within 12 months of starting regulatory preclinical studies) and launch. Twenty-seven of these are in formal regulatory studies and beyond. In addition, in the past three years, five new medicines have either been approved by Stringent Regulatory Authorities [those that adhere to the guidelines of the International Commission for Harmonisation (ICH), or prequalified by the World Health Organization (WHO)].

The portfolio of new medicines contains several generations of products. The oldest group reflects the requirement for fixed-dose, artemisinin-combination therapy (ACT), driven by the need to protect artemisinin from the emergence and spread of resistance. This therapy is based around active molecules that were first identified over 30 years ago. The central focus for the development process of this therapy has been ensuring that the historical data available match current international standards of safety and efficacy.

The call for the eradication of malaria in 2007 led to a new research agenda[1] laying out priorities with broader horizons. As well as the focus on case management of uncomplicated and severe malaria, there is now a need for medicines that prevent transmission, stop relapse and provide chemoprotection against new infections. These characteristics are described by Target Product Profiles (TPPs), which give a description of the ideal medicine and the minimum acceptable profile. TPPs provide drug discoverers with a common standard of the unmet clinical needs in malaria control and eradication, thereby allowing a better focus. TPPs were developed with input from countries, field-based clinicians, and discovery and development teams,[2] and are refined every two years.[3]

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