Recipharm Announces Commercial Manufacturing to Support Drug Launch Following FDA Approval
Recipharm, the contract development and manufacturing organisation (CDMO), recently announced ongoing large-scale commercial manufacturing of RedHill Biopharma’s 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.”
Reza Fathi, Senior Vice President R&D at RedHill, added “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.
Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) in the pharmaceutical industry employing almost 7,000 employees. Recipharm offers manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material and APIs, and pharmaceutical product development. Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. Recipharm’s turnover is approximately SEK 7.2 billion. The company operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK and the US and is headquartered in Stockholm, Sweden. The Recipharm B-share (RECI B) is listed on Nasdaq Stockholm. For more information visit www.recipharm.com.
RedHill Biopharma Ltd. is a specialty biopharmaceutical company, primarily focused on the development and commercialization of proprietary drugs for the treatment of gastrointestinal diseases. RedHill commercializes and promotes several gastrointestinal products in the US, Donnatal, EnteraGam, and Mytesi, and is planning to launch Aemcoloand Taliciain the US. RedHill’s key clinical late-stage development programs include: RHB-104, with positive results from a first Phase 3 study for Crohn’s disease; RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; RHB-102 (Bekinda), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; ABC294640 (Yeliva), a first–in–class SK2 selective inhibitor, targeting multiple oncology, inflammatory and gastrointestinal indications, with an ongoing Phase 2a study for cholangiocarcinoma; RHB-106, an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd. and RHB-107,a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases. For more information, visit www.redhillbio.com.
Total Page Views: 489