Catalent announced today that it entered into a commercial supply agreement with Phathom Pharmaceuticals for its acid blocker.
The commercial supply agreement covers Phathom’s lead compound, vonoprazan, which is a novel, orally active-potassium competitive acid blocker (P-CAB) for treating gastrointestinal diseases, according to a news release.
Phathom currently has vonoprazan in late clinical-stage development for treating gastric acid-related diseases and disorders, including gastroesophageal reflux disease (GERD) and Helicobacter pylori (H. pylori) bacterial infection. The company owns rights for developing and commercializing vonoprazan in the U.S., Europe and Canada.
Under the agreement, Catalent will undertake the commercial manufacturing and packaging of the product at its large-scale oral solid dose manufacturing site in Winchester, Kentucky, should the drug receive FDA approval.
“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,” Phathom Pharmaceuticals COO Dr. Azmi Nabulsi said in the release. “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.”
“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,” added Catalent president of softgel & oral technologies Dr. Aris Gennadios. “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.”