Development of Pediatric Formulation for Schistosomiasis

Schistosomiasis is a severe chronic inflammatory disease caused by parasitic worms and is endemic in 78 developing countries, infecting more than 243 million people globally every year. Schistosomiasis is the second most prevalent tropical disease in the world after malaria, and occurs primarily in developing countries with limited access to safe drinking water and adequate sanitation.
The standard recommended praziquantel treatment is available in tablets, suitable for adults and children from the age of six. Proper treatment of younger children with schistosomiasis is hampered due to missing clinical data and the fact that they cannot swallow these tablets because of their size and bitter taste.

The Pediatric Praziquantel Consortium was founded in July 2012 with the objective to develop and register a new praziquantel pediatric formulation for the treatment of schistosomiasis in preschool-age children, including infants and toddlers. Astellas Pharma has been a core partner in this partnership from establishment and has contributed by providing our expertise and technology in the area of pediatric formulation development and clinical development.

The pediatric formulation newly developed by Astellas uses its original drug formulation technology. The pediatric formulation was designed to be smaller than the existing tablet and to be orally dispersible so that it can be taken even without water, with reduction of bitterness. In addition, the pediatric formulation can be manufactured using simple production technology, while holding down production costs, and the tablets are stable even in the hot and humid environment of tropical areas. Astellas has transferred the technology and expertise needed to develop the pediatric formulation to a consortium partner in Brazil, thereby helping to build local pharmaceutical manufacturing capabilities.

Newly developed pediatric formulation (top) and existing tablet (bottom)

Newly developed pediatric formulation (top) and existing tablet (bottom)

The importance of this initiative has earned international recognition and has obtained a research grant from the Bill & Melinda Gates Foundation and a second research grant from the GHIT Fund in May 2015. The consortium is conducting Phase II clinical trials. Astellas continues to provide its expertise and technology to the consortium.

* GHIT Fund: Global Health Innovative Technology Fund. A product development fund for global health R&D. It is built on the strength of contributions from partners in the public, private, and civil sectors