Recipharm to Manufacture RedHill Biopharma’s FDC Therapy for Helicobacter pylori Infection

August 26, 2015
Pharmaceutical Technology Editors

PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-09-02-2015, Volume 11, Issue 9

Recipharm will be responsible for the supply of the remaining clinical-trial material and ongoing future commercial supply of RHB-105, the lead drug candidate developed by RedHill for the treatment of Helicobacter pylori bacterial infection.

Recipharm announced that it has signed an agreement with biopharmaceutical company RedHill Biopharma for the manufacturing of RHB-105, which is the lead late-stage patented drug candidate that RedHill is developing for the treatment of Helicobacter 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 new and proprietary fixed-dose combination (FDC) therapy of two antibiotics (amoxicillian and rifabutin) and a proton pump inhibitor (omeprazole) combined into an all-in-one oral capsule for the treatment of H. pylori infection. The formulation successfully met its primary endpoint in the first Phase III trial in June 2015.

Recipharm will invest approximately $1.55 million in manufacturing capabilities.

The complex manufacture of RHB-105 will be carried out across three of Recipharm’s facilities. The FDA-approved facilities in Fontaine and Pessac will manufacture the omeprazole mini-tablets, while in Strangnäs, the final product will be encapsulated and packaged for final release. The Strängnäs facility will be registered with FDA.

Commercial supply is expected to commence with initial launch into the US market, after regulatory approval by FDA. Supply to EU markets is anticipated after EU regulatory approval.

Source: Recipharm