Contract development relationship frames recent FDA approval. 

The FDA recently approved a first-in-class oral dose therapy for carcinoid syndrome diarrhea, a rare but debilitating symptom related to metastatic neuroendocrine tumors or mNets. Characterized as “pioneering,” Lexicon Pharmaceuticals, Inc. XERMELO (telotristat ethyl) received fast-track priority review and orphan designation more than a decade ago and began developing the formulation with contract development and manufacturing organization (CDMO) Catalent in 2007.

Commenting that its orphan drug is ready for commercial launch, Lexicon President and CEO explained the, “successful collaboration with Catalent means we are now able to make it available for the thousands of patients currently suffering from this condition.”

With FDA approval, Xermelo is ready for patients and commercial-scale manufacture – which Catalent announced it had secured after the culmination of ongoing strategic development to create a safe and effective drug.

Matthew Mollan, Catalent's Kansas City, Missouri site GM acknowledged Catalent’s central role, noting “We are pleased that the skill and expertise that our scientists have dedicated to this project for ten years has resulted in this pioneering treatment reaching the market,” he continued. “Catalent first partnered with Lexicon when the drug was in Phase I development, and continued to support its manufacture through to supplying launch products.”