Catalent Pharma Solutions announced that it will commercially manufacture Lexicon Pharmaceuticals, XERMELO following the FDA approval at its Kansas City facility.
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.
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’s General Manager, Matthew Mollan said that they are pleased that the skill and expertise that their scientists have dedicated to this project for ten years has resulted in this pioneering treatment reach the market. Catalent first partnered with Lexicon when the drug was in Phase I development, and continued to support its manufacture through to supplying launch products.
Lexicon’s president and CEO, Lonnel Coats said that they are proud to have discovered this ground-breaking orphan drug, and their successful collaboration with Catalent means they are now able to make it available for the thousands of patients currently suffering from this condition.