Lexicon Pharmaceuticals’ orphan drug, Xermelo, has been approved by the U.S. FDA for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Xermelo (telotristat ethyl) 250 mg is a first-in-class orally administered therapy. Catalent Pharma Solutions has been working in partnership with Lexicon since 2007 to develop the drug formulation, and will be manufacturing XERMELO for commercial supply.
 
“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,” said Matthew Mollan, Catalent’s general manager at its Kansas City, MO 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 chief executive officer.
 
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 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 support services, from formulation development and analytical testing, to clinical and commercial scale manufacturing and packaging of various oral dose forms.