Catalent today welcomed the recent announcement by Phathom Pharmaceuticals that the U.S. FDA has approved both VOQUEZNA™ TRIPLE PAK™ (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA™ DUAL PAK™ (vonoprazan tablets, amoxicillin capsules), for the treatment of Helicobacter pylori (H. pylori) infection in adults. Catalent has a supply agreement for the commercial manufacturing of vonoprazan at Catalent's large-scale oral solid dose manufacturing site in Winchester, Kentucky.
SOMERSET, N.J., June 9, 2022 /PRNewswire-PRWeb/ -- Catalent, the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today welcomed the recent announcement by Phathom Pharmaceuticals that the U.S. Food and Drug Administration (FDA) has approved both VOQUEZNA™ TRIPLE PAK™ (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA™ DUAL PAK™ (vonoprazan tablets, amoxicillin capsules), for the treatment of Helicobacter pylori (H. pylori) infection in adults. These new treatment options contain antibiotics conveniently packaged with vonoprazan, a novel potassium-competitive acid blocker (PCAB) and the first innovative acid suppressant from a new drug class approved in the U.S. in over 30 years. For more information on the VOQUEZNA treatment regimens, including important safety information, please click here.
Catalent originally announced that it had signed a supply agreement with Phathom Pharmaceuticals in September 2021, for the commercial manufacturing of vonoprazan at Catalent's large-scale oral solid dose manufacturing site in Winchester, Kentucky.
"Phathom's first FDA-approved products will provide an important new treatment option for the millions of patients in the U.S. with H. pylori infection," said Jay Buchanan, Vice President of Manufacturing and Supply Chain, Phathom Pharmaceuticals. "Since we began partnering with Catalent, the company's commitment to our program has been exceptional, and we are thankful for its support in advancing our mission to change the treatment landscape for patients with gastrointestinal disorders."
"This is obviously great news for Phathom, and we are pleased to be able to support yet another innovative product launch that puts patient health and wellbeing as a priority", added Aris Gennadios, Ph.D., President of Softgel & Oral Technologies at Catalent. "Our team at Winchester has an extensive history of supporting product launches, and the evolving needs and demands of our partners has led to us recently announcing a large-scale expansion at the site to ensure we have the capabilities and capacity to continue to support as many new programs as possible in the future."
Opened in 1992, Catalent's Winchester facility has evolved into one of the industry's premier sites for complex oral drug formulation and manufacturing. The site has launched more than 150 new products into the market since its inception and produces over three billion tablets and capsules annually. In May 2022, Catalent announced a $175 million investment to expand the site's capabilities to handle highly potent materials, as well as provide additional laboratory space and add further capacity for existing turnkey operations including roller compaction and fluid bed capacity.
About Catalent
Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.
Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of nearly 7,000 products annually. Catalent's expert workforce exceeds 19,000, including more than 2,500 scientists and technicians.
Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year. For more information, visit http://www.catalent.com.
More products. Better treatments. Reliably supplied.™
Media Contact
Chris Halling, Catalent Pharma Solutions, +44 (0)7580 041073, [email protected]
Richard Kerns, NEPR, +44 (0)161 728 5880, [email protected]
SOURCE Catalent Pharma Solutions
Share this article