Merck KGaA, Darmstadt, Germany, and Universal Agree on Contract Manufacturing for new Pediatric Medication Against Schistosomiasis

• Universal to produce new pediatric medication against schistosomiasis on a large scale in Kenya for endemic African countries
• The new pediatric drug is currently in clinical Phase III
• Collaboration contributes to the sustainability strategy of Merck KGaA, Darmstadt, Germany, and the United Nations’ Sustainable Development Goals

Merck KGaA, Darmstadt, Germany, a leading science and technology company, has entered into a contract manufacturing agreement with Universal Corporation Ltd., Nairobi, Kenya, a subsidiary of Strides Pharma Science Limited, India, for the large-scale production of a new pediatric medication. Production will begin once the medication has been registered. The drug is needed to treat the neglected tropical disease (NTD) schistosomiasis in preschool-aged children younger than six and is currently in late-stage development. The agreement with Universal includes building up extensive production capacities in Nairobi, Kenya for future provision of the treatment in endemic African countries. It adds to the manufacturing activities of Farmanguinhos, the federal governmental pharmaceutical laboratory of the Fiocruz Foundation in Brazil, which brings expertise in production and distribution.

“Universal has not only the necessary equipment and knowledge for this kind of production, but also a well-established quality assurance system. That is why we really look forward to establishing sustainable supply of the new medication together with our new local partner,” said Teresa Rodó, Head of Global Healthcare Operations at Merck KGaA, Darmstadt, Germany.

“As a group, our strategy has always focused on being in Africa for Africa. We are proud that by establishing local production, we will further support the regional economy and ensure sustainable and equitable access to the new pediatric medication against schistosomiasis for the young patients in need,” said Palu Dhanani, Chief Executive Officer of Universal.

For school-aged children and adults, praziquantel is the standard of care treatment for schistosomiasis. Merck KGaA, Darmstadt, Germany, makes it available by providing the World Health Organization with up to 250 million tablets per year and will continue delivering the treatment until the disease is eliminated. However, the vulnerable group of preschool-aged children has so far been left untreated in public health programs primarily due to the lack of an appropriate child-friendly formulation of the drug. Untreated schistosomiasis can lead to potentially fatal chronic inflammation of vital organs as well as anemia, stunted growth and impaired learning ability, all of which have devastating consequences for the lives of the youngest members of the population.

The new pediatric medication for preschool-aged children, arpraziquantel, is derived from praziquantel. It is smaller and orally dispersible – i.e. it dissolves quickly in the mouth or in water and has acceptable taste properties for children. It is currently being tested in a pivotal clinical Phase III trial in Kenya and Côte d’Ivoire to generate confirmatory data for registration. The new drug is being developed by the Pediatric Praziquantel Consortium, a public-private partnership led by Merck KGaA, Darmstadt, Germany, which addresses the medical needs of preschool-aged children infected with schistosomiasis.

“A world free of schistosomiasis is possible. With the new medication, we will be one important step closer to reaching this goal,” said Jutta Reinhard-Rupp, Head of the Global Health Institute at Merck KGaA, Darmstadt, Germany, and Chair of the Pediatric Praziquantel Consortium.

Within the scope of its Schistosomiasis Elimination Program, Merck KGaA, Darmstadt, Germany, has been fighting this NTD with its partner, the World Health Organization, since 2007. The company has donated more than 1.3 billion tablets of praziquantel, enabling treatment of 520 million school-aged children to date. The new medication will be an important building block in this program. Merck KGaA, Darmstadt, Germany, is also involved in several collaborative initiatives that build capacity and strengthen healthcare systems in low- and middle-income countries. These projects invest in local research & development, production and supply chain as well as in health infrastructure, education for behavioral change and training. The set-up of local African production for equitable access to the pediatric medication for schistosomiasis is one example of the collaborative efforts of Merck KGaA, Darmstadt, Germany, to enhance local health capacities in a sustainable manner in order to benefit global health. In this way, Merck KGaA, Darmstadt, Germany, addresses the key requirements of the World Health Organization’s 2030 Roadmap for NTDs and also contributes to the United Nations’ Sustainable Development Goals (mainly SDGs 3, 8, 9, and 17), in line with the company’s sustainability strategy.