Catalent will manufacture and package Phathom’s lead compound, vonoprazan, if the drug receives approval from the U.S. Food and Drug Administration, the company said in a statement.
“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,” said Dr. Aris Gennadios, president of softgel & oral technologies at Catalent.
Phathom develops and commercializes novel treatments for gastrointestinal diseases, and vonoprazan is a new class of medicines that block acid secretion in the stomach. The drug is currently in late clinical-stage development for the treatment of gastric acid-related diseases and disorders.
“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 Dr. Azmi Nabulsi, chief operating officer of 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.”
Catalent plans to manufacture the drug at its oral solid dose manufacturing site in Winchester, Kentucky, which opened in 1992 and has since launched more than 100 products, the company said. The facility produces more than 3 billion tablets and capsules per year.
“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,” Gennadios said.