The contract development and manufacturing organisation (CDMO) will produce RHB-105 for clinical trials and later for commercial supply.
The drug candidate contains two antibiotics, amoxicillian and rifabutin, as well as the proton pump inhibitor omeprazole in one oral dose. It targets Helicobacter pylori (H. pylori) bacterial infection, a market the companies say is worth $4.8bn (€4.2bn).
RHB-105 was successful in a Phase III study which ended in June.
Three site manufacture
Recipharm said RedHill’s order is a complicated manufacturing job and the first to involve three Recipharm sites.
FDA-approved facilities in Fontaine and Pessac, France will produce omeprazole pellets and a plant in Strängnäs, Sweden will encapsulate and package the final product. Recipharm will invest 13m Swedish Krona ($1.6m) in upgrading manufacturing at the Swedish site and will apply for FDA registration.
Erik Haeffler, VP, manufacturing services, Recipharm said spreading production across three sites is an “integrated solution to solve a complex manufacturing project.”
The companies said they expect RHB-105 to be launched in the US before the EU.
RedHill’s pipeline also includes an oral combination therapy in Phase III for Chrohn’s disease, a Phase III ondansetron pill for chemotherapy nausea, a bowel preparation licensed to Salix, and several Phase I and II candidates.