RHB-105 is being developed for the treatment of Helicobacter pylori (H. pylori) bacterial infection, a global market estimated at about $4.8 billion. Recipharm will be responsible for the supply of the remaining clinical trial material and ongoing future commercial supply.
RHB-105 is a new and proprietary fixed-dose oral combination therapy of two antibiotics (amoxicillian and rifabutin) and a proton pump inhibitor (omeprazole) combined into an all-in-one oral capsule with a planned indication for treatment of H. pylori infection. In June of this year, RHB-105 successfully met its primary endpoint in its first Phase III study.
This complex project straddles and integrates three of Recipharm’s manufacturing facilities, making it the first project of its kind within the organization. The FDA-approved facilities in Fontaine and Pessac will manufacture the Omeprazole mini-tablets, whilst in Strangnäs the final product will be encapsulated and packaged ready for final release.
To support this project, Recipharm will invest approximately SEK13 million ($1.55 million) in manufacturing capabilities. In addition, the Strängnäs facility will be registered with the US FDA. Commercial supply is expected to commence with initial launch into the US market, after regulatory approval by US FDA. Supply to EU markets is anticipated after this, pending EU regulatory approval.
Erik Haeffler, VP Manufacturing Services, Recipharm, commented: “This is a fantastic example of how Recipharm has been able to offer an integrated solution to solve a complex manufacturing project. We are looking forward to working on this project and supporting a successful clinical trial and launch of RHB-105.”
Guy Goldberg, Chief Business Officer of RedHill, said: “We are very pleased that we have entered into this partnership with Recipharm for this important and exciting product. Recipharm is able to offer us a one-stop-shop solution that is fairly unique. We are confident in Recipharm’s ability to deliver and look forward to working with them. With the successful first Phase III study we have just announced, we plan to meet with FDA in the coming months to discuss a path for approval for RHB-105. We believe RHB-105 could provide an important solution for patients and physicians for this critical infectious disease.”