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Lexicon bags FDA OK on lead drug for carcinoid syndrome, preps for a commercial launch

Lonnel Coats, Lexicon

Lexicon Pharmaceuticals $LXRX has completed a marathon development program with an FDA approval of telotristat ethyl (which will be sold as Xermelo and was formerly known as LX1032) for carcinoid syndrome, which is linked with severe diarrhea.

The oral drug inhibits tryptophan hydroxylase, or TPH, eliminating serotonin in the GI tract but leaving levels in the brain unaffected. Back in the summer of 2015, investigators outlined the first batch of Phase III data for the drug, demonstrating a reduction in bowel movements. Carcinoid syndrome is described as a rare and debilitating condition that affects people with metastatic neuroendocrine tumors, or mNET.

The drug targets serotonin production in mNET cells.

Ipsen has European rights and Lexicon holds on to commercialization rights in the critical US market. There’s no word yet on what this drug will cost. The Woodlands, TX-based Lexicon has a market cap of $1.7 billion. Its stock jumped 5% in after-market trading.

Lexicon managed the program from its inception, announcing Phase I data in the fall of 2008.

“We are proud to have discovered and developed this ground-breaking orphan drug, and it is an honor to make it available for the thousands of patients currently suffering from this condition who wish to lead a more routine life with fewer incidences of severe diarrhea,” noted CEO Lonnel Coats.

The biotech was forced to reorganize back in early 2014 as it circled its wagons around its other lead program, the SGLT1/2 inhibitor sotagliflozin (LX4211) for diabetes. Sanofi inked a billion-dollar deal on that program, which posted positive late-stage data for Type 1 diabetes last fall.

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