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April 14, 2014
06:10 EDTLXRXLexicon achieves positive results in Type 1 diabetes clinical trial
Lexicon Pharmaceuticals announced positive, top-line results in a Phase 2 clinical trial of LX4211 in type 1 diabetes, which achieved the primary endpoint of reducing mealtime insulin use as well as several secondary endpoints, including improved glycemic control. LX4211 is an oral, first-in-class, dual inhibitor of sodium glucose transporters 1 and 2 that is designed to lower blood glucose levels through two insulin-independent mechanisms of action. In the placebo-controlled, double-blind, 28-day study, LX4211 reduced the total daily mealtime bolus insulin dose by 32% compared to 6% for placebo, while significantly improving glycemic control with a mean HbA1c reduction of 0.55% in the LX4211-treated group compared to a reduction of only 0.06% with placebo. This improvement was accompanied by significant improvement in the time spent in a glucose range of 70-180 mg/dl, a significant reduction in time in hyperglycemic range, and no increase in hypoglycemia. Multiple measures indicated that LX4211 treatment resulted in reduced variability in blood glucose levels. Overall, LX4211 was well tolerated with no discontinuations of study medication due to adverse events.
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October 22, 2014
05:17 EDTLXRXIpsen, Lexicon enter into ex-North America/Japan licensing agreement
Ipsen (IPSEY) and Lexicon Pharmaceuticals (LXRX) announced that they have entered into an exclusive licensing agreement for Ipsen to commercialize telotristat etiprate outside of North America and Japan, with a focus on the treatment of carcinoid syndrome. Lexicon retains sole rights to commercialize telotristat etiprate in the United States, Canada and Japan. Lexicon is conducting Phase 3 clinical trials of telotristat etiprate for carcinoid syndrome, a serious condition caused by symptomatic neuroendocrine tumors, which produce large amounts of serotonin. Carcinoid syndrome is characterized by severe diarrhea, flushing and, in some cases, heart valve damage. Telotristat etiprate is an oral, small-molecule inhibitor of tryptophan hydroxylase, or TPH, that reduces peripheral serotonin production without affecting brain serotonin levels. Telotristat etiprate has received fast track status and orphan drug designation from the FDA, and has received orphan drug designation from the European Medicines Agency. Under the financial terms of the agreement, Lexicon is eligible to receive up to $145M, comprising $23M upfront payment and additional payments contingent upon achievement of clinical, regulatory and commercial milestones. In addition, Lexicon is also eligible to receive royalties on net sales of telotristat etiprate in the licensed territory.

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