Catalent provides commercial manufacturing of Lexicon Pharmaceuticals' orphan drug Xermelot following FDA approval

Xermelo is a first-in-class orally administered therapy for the treatment of carcinoid syndrome diarrhea.

Xermelo (telotristat ethyl) 250 mg is a first-in-class orally administered therapy for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.

“We are pleased that the skill and expertise that our scientists have dedicated to this project for 10 years has resulted in this pioneering treatment reach the market,” commented Matthew Mollan, Catalent's General Manager at its Kansas City, Missouri site. “Catalent first partnered with Lexicon when the drug was in Phase I development, and continued to support its manufacture through to supplying launch products.”

"We are proud to have discovered this ground-breaking orphan drug, and our successful collaboration with Catalent means we are now able to make it available for the thousands of patients currently suffering from this condition,” added Lonnel Coats, Lexicon's President and CEO.

Carcinoid syndrome is a rare condition that occurs in patients living with metastatic neuroendocrine tumors (mNETs) and is characterized by frequent and debilitating diarrhea that often prevents patients from leading active, predictable lives, as well as by facial flushing, abdominal pain, fatigue and, over time, heart valve damage.

Catalent undertook development and manufacture of the drug at its 450,000-sq-ft Kansas City facility, where the company provides a range of fully integrated support services, from formulation development and analytical testing, to clinical and commercial scale manufacturing and packaging of various oral dose forms.