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news.Swedish contract development and manufacturing organization (CDMO) Recipharm has signed an agreement with Israeli biopharmaceutical firm RedHill Biopharma to manufacture its late-stage patented drug candidate, RHB-105 to treat Helicobacter pylori (H. pylori) bacterial infection.
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Under the deal, Recipharm will be responsible for the supply of the remaining clinical trial material and ongoing future commercial supply.
RHB-105 is a new fixed-dose oral combination therapy of two antibiotics amoxicillian and rifabutin as well as a proton pump inhibitor omeprazole combined into an all-in-one oral capsule with a planned indication to treat H. pylori infection.
The company noted that in June, RHB-105 successfully met its primary endpoint in its first Phase III trial.
The deal will see FDA approved facilities in Fontaine and Pessac manufacture the Omeprazole mini-tablets, whilst in Strangnäs the final product will be encapsulated and packaged ready for final release.
Recipharm intends to invest about SEK13m ($1.55m) in manufacturing capabilities in order to support this project.
Additionally, the Strängnäs facility will be registered with the US FDA.
Recipharm Manufacturing services vice-president Erik Haeffler said: "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."
The company noted that commercial supply is expected to start with initial launch into the US market, after regulatory approval by US FDA, while supply to EU markets is expected after this and upon EU regulatory approval.