THE WOODLANDS, Texas, March 30, 2016 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of telotristat etiprate, an oral drug for the treatment of carcinoid syndrome. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Lexicon has requested a Priority Review by the FDA as part of the NDA filing.
"The filing of the NDA for telotristat etiprate brings us one step closer to the possibility of bringing this innovative new investigational treatment to the market to improve the lives of the community of patients and caregivers who live with carcinoid syndrome on a daily basis," said Lexicon President and Chief Executive Officer, Lonnel Coats. "We look forward to working closely with the FDA during the review process."
The NDA filing is supported by the results from TELESTAR, a pivotal Phase 3 clinical trial of telotristat etiprate in patients with carcinoid syndrome, and TELECAST, a Phase 3 companion study to TELESTAR. Results from TELESTAR demonstrated 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. Top-line results from TELECAST demonstrated a statistically significant reduction in urinary 5-hydroxyindoleacetic acid (5-HIAA, the main metabolite of serotonin) at week 12 (p<0.001) as compared to placebo, meeting that study's primary endpoint. The proportions of patients with treatment-emergent adverse events, serious adverse events and discontinuation due to adverse events were generally similar between the telotristat etiprate and placebo arms in both studies.
Carcinoid syndrome is a rare disease affecting thousands of cancer patients with metastatic neuroendocrine tumors (mNETs) that have spread to the liver and other organs from the gastrointestinal tract. The condition is characterized by frequent and debilitating diarrhea that often prevents patients from leading active, predictable lives, as well as facial flushing, abdominal pain, fatigue and, over time, heart valve damage.
About Telotristat Etiprate
Discovered using Lexicon's unique approach to gene science, telotristat etiprate is the first investigational drug in clinical studies to target tryptophan hydroxylase, an enzyme that triggers the excess serotonin production within mNET cells that leads to carcinoid syndrome. While existing treatments for carcinoid syndrome work to reduce the release of serotonin outside tumor cells, telotristat etiprate works at the source to reduce serotonin production within the tumor cells. By specifically inhibiting serotonin production, telotristat etiprate seeks to control this important driver of carcinoid syndrome and, in turn, provide patients with more control over their disease.
Telotristat etiprate has received Fast Track and Orphan Drug designation from the U.S. Food and Drug Administration.
Lexicon retains rights to market telotristat etiprate in the U.S. and Japan, and is building the in-house commercial infrastructure to serve the U.S. market. Lexicon has a license and collaboration agreement with Ipsen to commercialize telotristat etiprate in Europe and other countries outside the U.S. and Japan.
Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in oncology, diabetes and metabolism. For additional information please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements," including statements relating to Lexicon's clinical development of telotristat etiprate (LX1032) and the results of and projected timing of clinical trials and the potential therapeutic and commercial potential of telotristat etiprate. In addition, this press release also contains forward-looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including the risk that clinical studies of telotristat etiprate may be halted, delayed or otherwise not demonstrate safety or efficacy, the risk that Lexicon and its licensees may be unable to file for regulatory approval of telotristat etiprate with the FDA and other regulatory authorities in accordance with its currently anticipated timelines, the risk that the FDA and other regulatory authorities may not grant regulatory approval of telotristat etiprate in accordance with Lexicon's currently anticipated timelines or at all, and the risk that such regulatory approvals, if granted, may have significant limitations on the approved use of telotristat etiprate. As a result, telotristat etiprate may never be successfully commercialized. Other risks include Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other potential drug candidates, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2015, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE Lexicon Pharmaceuticals, Inc.