Catalent to manufacture Phathom gastrointestinal medicine


P-CABs are a class of medicines that block acid secretion in the stomach

Catalent to manufacture Phathom gastrointestinal medicine

Catalent, a global provider of development sciences and manufacturing platforms for medicines, has announced a commercial supply agreement with Phathom Pharmaceuticals, a late clinical-stage biopharmaceutical company focused on developing and commercialising novel treatments for gastrointestinal diseases. The agreement covers the commercial manufacturing and packaging of Phathom’s lead compound, vonoprazan, an orally active-potassium competitive acid blocker (P-CAB).

P-CABs are a 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 commercialisation of vonoprazan in the US, Europe, and Canada.

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, Kentucky.

“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, MD, COO of Phathom Pharmaceuticals. “This agreement further provides us with scalable commercialisation resources and brings us closer to delivering on our commitment to change the treatment landscape for acid-related gastrointestinal diseases.”

“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,” commented Dr Aris Gennadios, President, Softgel & Oral Technologies, Catalent. “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 commercialisation.”

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In 2019, Catalent’s Winchester facility undertook a $40m investment that saw the installation of 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.