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Company Update (NASDAQ:LXRX): Lexicon Pharmaceuticals, Inc. Reports 3rd Quarter Financial Results and Discusses Collaboration with Sanofi for Sotagliflozin


Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) reported financial results for the third quarter ended September 30, 2015 and provided an overview of key milestones for the company’s lead drug candidates.

Earlier today, Lexicon announced that it entered into a collaboration and license agreement with Sanofi for the worldwide development and commercialization of sotagliflozin. Under the terms of the agreement, Lexicon will receive an upfront payment of $300 million and is eligible to receive development, regulatory and sales milestone payments of up to $1.4 billion. Lexicon is also entitled to tiered, escalating royalties on net sales of sotagliflozin. The financial results reported in this press release are as of September 30, 2015 and do not reflect any impact of this collaboration.

“As anticipated, 2015 has been a transformational year for Lexicon and our two lead drug candidates, telotristat etiprate and sotagliflozin,” said Lexicon President and Chief Executive Officer Lonnel Coats. “We announced positive results from our pivotal Phase 3 TELESTAR study of telotristat etiprate during the third quarter and earlier today we announced a strategic collaboration with Sanofi that is designed to unlock the full potential of sotagliflozin for patients living with diabetes.”

Pipeline Progress

Telotristat etiprate is the first investigational drug in clinical studies to target tryptophan hydroxylase (TPH), an enzyme that triggers the excess serotonin production within metastatic neuroendocrine tumor cells that leads to carcinoid syndrome, a condition characterized by serious consequences including frequent and debilitating diarrhea, facial flushing, abdominal pain, and heart valve damage.

Top-line results from Lexicon’s Phase 3 TELESTAR study showed that patients who added telotristat etiprate to the standard of care at both the 250 mg and 500 mg doses experienced a statistically significant reduction from baseline compared to placebo in the average number of daily bowel movements over the 12-week study period (p<0.001), meeting the study’s primary endpoint.

Patients who received 250 mg of telotristat etiprate experienced a reduction of 1.71 bowel movements (29%) in the average number of daily bowel movements during the final week of the study compared to baseline, and those in the 500 mg arm experienced a reduction of 2.11 bowel movements (35%); the placebo group showed a reduction of 0.87 bowel movements (17%).

A substantially greater proportion of patients on telotristat etiprate achieved a durable response (44 percent and 42 percent in the 250 mg and 500 mg arms, respectively), defined as at least a 30 percent reduction in daily bowel movements over at least...