Recipharm AB, a contract development and manufacturing organization based in Jordbro, Sweden, has signed an agreement with the Israeli biopharmaceutical company RedHill Biopharma Ltd for the manufacturing of RedHill's late-stage drug candidate, RHB-105, which is being developed for treating Helicobacter pylori (H. pylori) bacterial infection. Recipharm will be responsible for the supply of the remaining clinical trial material and ongoing future commercial supply.

RHB-105 is a 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. The drug is in Phase III development.The supply pact involve the use of Recipharma’s facilities in Fontaine and Pessac, France, which will manufacture the omeprazole mini-tablets, and its facility in Strangnäs, Sweden, where the final product will be encapsulated and packaged ready for final release.

To support this project, Recipharm will invest approximately SEK 13 million ($1.55 million) in manufacturing capabilities. In addition, the Strängnäs facility will be registered with the US Food and Drug Administration. Commercial supply is expected to commence following regulatory approvals in the US and European Union.

Source: Recipharm