The new drug is currently being tested in a Phase 3 clinical trial in Kenya and Côte d’Ivoire
Merck logo in front of the headquarters. (Credit: Merck KGaA, Darmstadt, Germany.)
Merck has signed a contract manufacturing agreement with Universal for the large-scale production of a new paediatric medication for schistosomiasis.
Under the agreement, Universal, a subsidiary of India-based Strides Pharma Science, will start large scale production of a new paediatric treatment arpraziquantel in Kenya, for distribution in African countries.
The new drug, under late-stage development, is intended to treat the neglected tropical disease (NTD) schistosomiasis in children, aged below six years.
Praziquantel is the standard of care treatment for schistosomiasis in school-aged children and adults. The new paediatric medication arpraziquantel is derived from praziquantel.
Arpraziquantel is designed to be smaller in size, and orally dispersible, along with acceptable taste properties for preschool-aged children, said the company.
Merck global healthcare operations head Teresa Rodó said: “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.”
Schistosomiasis is a chronic, and most common parasitic disease in tropical countries, usually transmitted by the flatworms.
The disease is prevalent in tropical and subtropical regions where large populations lack access to clean water and sanitary installations, and its infection is high among school-aged children.
If left untreated, schistosomiasis may lead to potentially fatal chronic inflammation of vital organs along with anaemia, stunted growth and impaired learning ability.
The new drug is currently being tested in a Phase 3 clinical trial in Kenya and Côte d’Ivoire to generate confirmatory data for registration.
The Phase 3 clinical trial programme is led by the Pediatric Praziquantel Consortium, Merck’s public-private partnership, to addresses the needs of children with schistosomiasis.
Merck said that the collaboration aims to expand the production of arpraziquantel in Nairobi, to ensure future supply in endemic African countries, after its registration.
In November last year, the company has agreed to acquire clinical-stage biopharmaceutical company VelosBio, in an all-cash deal valued at $2.75bn.