PATH welcomes positive steps on price, donations for GlaxoSmithKline's RTS,S malaria vaccine candidate

PATH today welcomed the announcements made by GlaxoSmithKline (GSK) CEO Andrew Witty concerning the RTS,S malaria vaccine candidate, currently in a large, late-stage clinical trial that is supported by the PATH Malaria Vaccine Initiative (MVI), a vaccine development program of PATH and GSK.

“The announcements regarding sustainable pricing and vaccine donations to PATH are positive steps in the long pathway from discovery to delivery of RTS,S,” said Christian Loucq, director of MVI. “These commitments help to illustrate the potential of product development partnerships—like the one between MVI and GSK Biologicals—for meeting the health needs of people in developing countries.”

In a speech today at the Council on Foreign Relations, Witty committed to setting a price for RTS,S that would cover GSK’s costs and generate a small return that would be re-invested in research and development for next-generation malaria vaccines and vaccines against other neglected diseases. GSK also committed to donating at least 12.5 million doses of RTS,S (if approved for use) to PATH.

GSK Biologicals, the vaccine division of GSK, and PATH signed a collaboration agreement in 2001 to pursue the pediatric clinical development of RTS,S in Africa. To advance the development program, African research centers in five countries, and collaborating institutions, joined the partnership. Centers in two additional African countries have joined for the Phase 3 trial. Together, these partners comprise the Clinical Trials Partnership Committee and lead the clinical development of RTS,S.

The RTS,S vaccine was invented, developed, and manufactured in laboratories at GSK Biologicals’ headquarters in Belgium, with the research starting in the late 1980s. The vaccine was initially tested in US volunteers in the mid-1990s, as part of a collaboration with the Walter Reed Army Institute of Research.

Funding for the development of this vaccine candidate has been made possible through the support of the Bill & Melinda Gates Foundation, which has provided more than $200 million in grant monies to MVI for this project since 2001.

“Like other PATH programs, MVI’s mission goes beyond development of a health intervention to ensuring that it is available at the lowest price possible and readily accessible to all who need it,” said Christopher J. Elias, president and CEO of PATH.

“In light of the commitments made today and as we get closer to the day that the RTS,S vaccine candidate—if all goes well—could be available for use, we look forward to working with GSK, as well as other global partners, to ensure that malaria vaccines are available to the children that need them most.”

The PATH Malaria Vaccine Initiative (MVI) is a global program established at PATH in 1999 through an initial grant from the Bill & Melinda Gates Foundation. MVI's mission is to accelerate the development of malaria vaccines and ensure their availability and accessibility in the developing world. MVI's vision is a world free from malaria. For more information, please visit www.malariavaccine.org.

Posted January 20, 2010.