Catalent, a global provider of development sciences and manufacturing platforms for medicines, including biotherapeutics, cell and gene therapies and consumer health products, has signed a commercial supply agreement with Phathom Pharmaceuticals, a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, for its lead compound, vonoprazan, which is a novel, orally active-potassium competitive acid blocker (P-CAB).
 
P-CABs are a new class of medicines that block acid secretion in the stomach. Vonoprazan is currently in late clinical-stage development for the treatment of gastric acid-related diseases and disorders, including gastroesophageal reflux disease (GERD) and Helicobacter pylori (H. pylori) bacterial infection. Phathom has the rights for the development and commercialization of vonoprazan in the U.S., Europe, and Canada.
 
Under the terms of the agreement, should the drug receive FDA approval, Catalent will undertake the commercial manufacturing and packaging of the product at its large-scale oral solid dose manufacturing site in Winchester, KY.
 
“As Phathom readies for the potential approval and launch of our first product, we are pleased to have secured Catalent as a strategic partner to support our vonoprazan commercial manufacturing and packaging capabilities,” said Azmi Nabulsi, chief operating officer, Phathom Pharmaceuticals. “This agreement further provides us with scalable commercialization resources and brings us closer to delivering on our commitment to change the treatment landscape for acid-related gastrointestinal diseases.”
 
Aris Gennadios, president, softgel and oral technologies, Catalent, said, “This agreement is the start of long-term partnership between Catalent and Phathom, and we are pleased to be able to be part of a program that aligns with our ‘patient first’ philosophy, as this drug offers a true innovation for patients. Our Winchester facility has an extensive history of manufacturing and robust track record in supporting product launches, and has all the experience and capabilities, particularly related to fluid bed technologies, to meet the needs of this program as it nears commercialization.”
 
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 100 new products into the market since its inception and produces over three-billion tablets and capsules annually. The site doubled its footprint to 180,000 square feet in 2015, and in 2019 undertook a $40 million investment that saw the installation of new equipment to increase its tablet and capsule manufacturing capabilities, including laser drill for osmotic drug delivery, stick pack dosage manufacturing, integrated packaging lines, and expanded roller compaction and fluid bed capacity.