Business
LEXICON PHARMACEUTICALS REPORTS FOURTH QUARTER AND FULL-YEAR 2019 FINANCIAL RESULTS AND PROVIDES A BUSINESS UPDATE
XERMELO® (telotristat ethyl) 2019 U.S. Net Sales Reached $31.0 Million THE WOODLANDS, Texas, March 12, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc.
About this update from Lexicon Pharmaceuticals, Inc.
[{"type":"text","content":" XERMELO® (telotristat ethyl) 2019 U.S. Net Sales Reached $31.0 Million\n THE WOODLANDS, Texas, March 12, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months and full-year ended December 31, 2019 and provided a business update. “In 2019, we achieved continued growth in our XERMELO (telotristat ethyl) business of nearly 25% year-over-year and made significant strides in advancing pipeline initiatives such as telotristat ethyl in biliary tract cancer and LX9211 in neuropathic pain,” said Lonnel Coats, Lexicon’s president and chief executive officer. “We expect initial clinical efficacy data for telotristat ethyl in biliary tract cancer by the end of this year. As for LX9211, we are initiating a proof-of-concept study in diabetic peripheral neuropathic pain in the first half of this year.” “We received a response yesterday from the Center for Drug Evaluation and Research (CDER) to our appeal of the FDA’s complete response letter (CRL) for sotagliflozin in type 1 diabetes,” continued Mr. Coats. “The response confirmed the CRL decision, and we are now evaluating the feedback they provided in their response.\" “We are engaged in discussions around potential partnerships for sotagliflozin, which will be necessary to enable completion of the long-term outcomes studies, SCORED and SOLOIST, that are designed to demonstrate benefits in and support labeling for heart failure and chronic kidney disease.” Fourth Quarter and Full-Year 2019 Product and Pipeline Highlights XERMELO® (telotristat ethyl) XERMELO U.S. net sales were $31.0 million in 2019.In December, Lexicon completed a safety review of the initial safety run-in cohort of The Telotristat Ethyl for Advanced Biliary Tract Cancer, or TELE-ABC, study, a Phase 2a clinical study of telotristat ethyl in patients with biliary tract cancer. Safety analysis from the first six patients who completed at least a 21-day cycle of treatment with telotristat ethyl in combination with cisplatin and gemcitabine supported the continuation of enrollment with no adjustment in the telotristat ethyl 500 mg three times daily dosing regimen. Zynquista™ (sotagliflozin) In December, Lexicon announced topline data from the Phase 3 SOTA-EMPA study of sotagliflozin in type 2 diabetes. Sotagliflozin 400 mg achieved the primary endpoint of sup...