The Swedish CDMO will invest approximately SEK13m in manufacturing capabilities
Swedish contract development and manufacturing organisation Recipharm has signed an agreement with Israeli biopharmaceutical company RedHill Biopharma for the manufacture of a late-stage drug candidate for the treatment of Helicobacter pylori (H. pylori) infection.
Recipharm will be responsible for the supply of the remaining clinical trial material and ongoing future commercial supply.
RHB-105 is RedHill's new fixed-dose oral combination therapy of two antibiotics (amoxicillian and rifabutin) and a proton pump inhibitor (omeprazole) combined into an oral capsule for the treatment of H. pylori infection. In June, RHB-105 successfully met its primary endpoint in its first Phase III study.
The project straddles three of Recipharm’s manufacturing facilities making it the first project of its kind within the company. The FDA-approved facilities at Fontaine and Pessac in France will manufacture the Omeprazole mini-tablets, while the final product will be encapsulated and packaged in Strangnäs, Sweden ready for final release.
Recipharm will invest approximately SEK13m (US$1.55m) in manufacturing capabilities. In addition, the Strängnäs facility will be registered with the US FDA.
Commercial supply is expected to start with initial launch into the US market, after regulatory approval by FDA. Supply to EU markets is anticipated after this following EU regulatory approval.
Erik Haeffler, VP Manufacturing services at Recipharm, 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.'