Recipharm, the contract development and manufacturing organisation (CDMO), announced today ongoing large-scale commercial manufacturing of RedHill Biopharma’s (Nasdaq: RDHL) drug, Talicia® (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10 mg/250 mg/12.5 mg, for its planned launch in the first quarter 2020.
RedHill and Recipharm have been working in partnership since 2015 to develop and manufacture the product, which is the first rifabutin-based therapy approved treatment for the treatment of Helicobacter pylori infection.
Throughout the development process Recipharm has been responsible for establishing manufacturing methods, scaling up from small scale concept to technology batch and clinical trial material, and establishing a compliant commercial manufacturing process.
Erik Haeffler, VP of Manufacturing Services said: “Recipharm’s end-to-end development and manufacturing capabilities mean we have been able to support RedHill throughout the entire journey to market.
“We’ve been working closely with RedHill over the past few years to develop and manufacture Talicia®, so gaining FDA approval marks an important milestone in the journey and is testament to the hard work of both teams.”
H. pylori infection, which is caused by a type of bacteria that grows in the digestive tract, affects over 50% of the population worldwide and approximately 35%, or over 100 million people, in the US.
Reza Fathi, Senior Vice President R&D at RedHill said: “This is a significant moment in our shared collaboration with Recipharm. We have been working diligently to develop and receive FDA approval for Talicia®. This would not have been possible without the mutual activities and work by all of the teams at RedHill and Recipharm, at three different sites.”
Talicia is designed to address the challenge of high and growing bacterial resistance and diminished efficacy of existing treatments. It is eligible for eight years of US market exclusivity under QIDP designation and its patent protection extends until 2034.