European Medicines Agency (EMA) Validates Application for Arpraziquantel to Treat Schistosomiasis in Preschool-Aged Children

About Arpraziquantel

The current standard of care treatment for schistosomiasis is praziquantel. Praziquantel is safe, effective, and suitable for school-aged children and adults. However, an appropriate drug for pre-school aged children has to date been elusive. Arpraziquantel aims to close this treatment gap for schistosomiasis (S. mansoni, S. haematobium). Arpraziquantel contains the pharmacologically active enantiomer of praziquantel. The new tablet is smaller, (oro)-dispersible – it dissolves in the mouth or in water, has taste properties that are acceptable for children, and withstands the challenges presented by a tropical climate. It was developed by Astellas Pharma Inc. in Japan, subsequently optimized by Merck KGaA, Darmstadt, Germany, in Germany and transferred for clinical & manufacturing supply to Farmanguinhos in Brazil. In addition, the more recent partnership with Universal Corporation Ltd. in Kenya prepares for extensive local production capacities in and for Africa. Arpraziquantel is not approved for any use in any country.

About Schistosomiasis

Schistosomiasis is a chronic condition and one of the most common and most devastating parasitic diseases in tropical countries. It is estimated that approximately 240 million people are infected worldwide and that around 200,000 die from it each year. Flatworms transmit the disease. It is widespread in tropical and subtropical regions where large sections of the population have no access to clean water and sanitary installations. People become infected with the parasite via contact with freshwater, for example while working, swimming, fishing or washing their clothes. The minuscule larvae penetrate human skin, enter the blood vessels and attack internal organs. The infection rate is particularly high among children.

About the Pediatric Praziquantel Consortium

The Pediatric Praziquantel Consortium is an international not-for-profit partnership that aims to help improving child’s health by addressing the medical needs of preschool-aged children with schistosomiasis for potentially reducing the global burden caused by this disease. Its mission is to develop, register and provide access to a suitable pediatric drug for treating schistosomiasis in children three-months to six years of age. For more information, and to see an overview of all Consortium partners, visit the Consortium website: www.pediatricpraziquantelconsortium.org

The Consortium is financially supported by Merck KGaA, Darmstadt, Germany; in-kind contributions from the Consortium’s partners; and grants from the Bill and Melinda Gates Foundation (2012), the Global Health Innovative Technology Fund (GHIT) (2013, 2014, 2016, 2019 & 2021), and the European & Developing Countries Clinical Trials Partnership (EDCTP), under its second program supported by the European Union (2018 & 2021).

About the Schistosomiasis Elimination Program of Merck KGaA, Darmstadt, Germany

Merck KGaA, Darmstadt, Germany, initiated its Schistosomiasis Elimination Program in cooperation with the World Health Organization (WHO) in 2007. Since then, more than 1.5 billion tablets have been donated, enabling the treatment of over 600 million school-aged children. Merck KGaA, Darmstadt, Germany, has committed itself to maintaining its efforts in the fight against schistosomiasis until the disease is eliminated as a public health burden. To this end, each year Merck KGaA, Darmstadt, Germany, provides up to 250 million tablets for the treatment of schistosomiasis through its partnership with WHO. The planned annual donation has a value of USD 32.5 million. In addition, Merck KGaA, Darmstadt, Germany, has adopted an integrated schistosomiasis strategy that is implemented in close collaboration with partners worldwide and focuses on: treatment, research & development, WASH (Water, Sanitation & Hygiene) & health education, advocacy & partnerships. More information about the Schistosomiasis Elimination Program is available at www.makingschistory.com.

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About Merck KGaA, Darmstadt, Germany

Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across life science, healthcare and electronics. More than 60,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2021, Merck KGaA, Darmstadt, Germany, generated sales of € 19.7 billion in 66 countries.

The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.