Imagine trying to clean a house with two different cleaners, but you can only use one at a time. This project combines two powerful medicines into a single pill to kill parasitic worms more effectively. It's like a 'two-in-one' solution that makes treatment easier for patients and more efficient for health programs.
Current single-drug treatments for soil-transmitted helminths are failing to control infections effectively. This creates a gap in the market for a more potent, easy-to-administer combined therapy.
A fixed-dose combination (FDC) tablet of albendazole and ivermectin and a supporting evidence package for WHO and national regulatory approval.
If you are a generic drug manufacturer dealing with low efficacy of single-drug treatments for parasites — this project developed a fixed-dose combination of albendazole and ivermectin that shows significantly superior efficacy against T. trichiura.
If you are a medical supply chain provider dealing with the complexity of distributing multiple medications for neglected tropical diseases — this project developed a single-tablet FDC that simplifies the supply and costing model for endemic settings.
If you are a regulatory agency dealing with the need for updated safety data for combined therapies — this project developed a multidisciplinary evidence package for policy making and WHO guidance.
Based on available project data, the project is developing a model for sustainable supply and costing appropriate for widespread use in endemic country settings, but specific price points are not listed.
The project is led by Laboratorios Liconsa SA, a pharma company that has already obtained WHO prequalification for generic ivermectin, suggesting a high capacity for industrial scale.
Based on available project data, the project focuses on implementation, regulatory submission in Ghana and Kenya, and WHO guidance rather than specific patent filings.
The combination received a positive opinion from the EMA in accordance with Article 58 of Regulation (EC) No 726/2004.
The project runs from 2023-07-01 to 2027-06-30, with goals to align with WHO 2030 targets for eliminating STH morbidity.
The consortium is heavily weighted toward implementation and research, consisting of 7 partners across 5 countries. While the industry ratio is low at 14% (1 company), the coordinator is Laboratorios Liconsa SA, a pharmaceutical firm with proven WHO prequalification experience, which provides the necessary industrial bridge to move the 4 research entities' findings into the market.
Contact Laboratorios Liconsa SA regarding FDC implementation
Contact us to explore licensing opportunities for the FDC evidence package.
