Catalent to Manufacture Lexicon Pharmaceuticals' Orphan Drug Xermelo

PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-06-08-2017, Volume 12, Issue 6

Catalent has been working together with Lexicon to develop the drug formulation of Xermelo, which has now been approved by FDA for the treatment of carcinoid syndrome diarrhea.

Catalent Pharma Solutions has welcomed FDA’s approval of Lexicon Pharmaceuticals’ orphan drug, Xermelo (telotristat ethyl), for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.

Since 2007, Catalent has been working together with Lexicon to develop the drug formulation. Catalent undertook development and manufacture of the drug at its 450,000-square-foot Kansas City facility, where the company provides a range of services, from formulation development and analytical testing, to clinical and commercial-scale manufacturing and packaging of various oral-dose forms. Following the approval by FDA, Catalent will be manufacturing the product for commercial supply.

“Catalent first partnered with Lexicon when the drug was in Phase I development, and continued to support its manufacture through to supplying launch products,” said Matthew Mollan, Catalent's general manager at its Kansas City, Missouri site, in a press statement.

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. “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.

Source: Catalent