Catalent Pharma Solutions welcomed Lexicon Pharmaceuticals’ announcement that Xermelo, has been approved by the U.S. Food and Drug Administration (FDA). Catalent has been working in partnership with Lexicon since 2007 to develop the drug formulation, and will be manufacturing Xermelo for commercial supply.
Xermelo (telotristat ethyl) 250 mg is an 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 ten years has resulted in this pioneering treatment reach the market,” Matthew Mollan, Catalent's General Manager at its Kansas City, Missouri site said. “Catalent first partnered with Lexicon when the drug was in Phase I development, and continued to support its manufacture through to supplying launch products.”
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-square-foot Kansas City facility, where the company provides a range of support services, from formulation development and analytical testing, to clinical and commercial scale manufacturing and packaging of various oral dose forms.