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Deal is dependent on FDA approval of Phathom’s vonoprazan compound
Catalent, a contract development and manufacturing organization (CDMO), has signed a commercial supply agreement with Phathom Pharmaceuticals, a late clinical-stage biopharma company focused on developing and commercializing treatments for gastrointestinal diseases, for its compound, vonoprazan, 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. Currently, vonoprazan is 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 owns rights for the development and commercialization of this P-CAB in the US, Europe and Canada.
Per the agreement, if the drug is approved by FDA, Catalent will be responsible for 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, MD, 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.”