The Woodlands, Texas, October 5, 2016 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has entered into an agreement to buy out its remaining obligations under its clinical development financing arrangement with Symphony Icon Holdings LLC upon regulatory approval in the United States for the marketing and sale of telotristat ethyl.
“In light of progress in the process of regulatory review of telotristat ethyl for carcinoid syndrome, we felt this would be an opportune time to reach a favorable settlement of the remaining financial obligations under our collaboration with Symphony Icon,” said Jeffrey L. Wade, Lexicon’s executive vice president, corporate and administrative affairs and chief financial officer. “The buyout arrangement will reduce the overall amount of our payment obligations and eliminate the sharing of future milestone payment and other license proceeds relating to telotristat ethyl.”
Under the buyout arrangement, Lexicon will make a single payment to Symphony Icon of $21.013 million upon U.S. regulatory approval of telotristat ethyl. The buyout will replace and eliminate the remaining contingent payments of up to $29.550 million for which Lexicon was obligated under the terms of the Symphony collaboration in effect prior to the buyout agreement. Consistent with the terms of the Symphony collaboration previously in effect, the buyout payment may be payable in cash or a combination of cash and up to 50% in Lexicon common stock, at Lexicon’s option.
About Telotristat Ethyl
Discovered using Lexicon’s unique approach to gene science, telotristat ethyl is the first investigational drug in clinical studies to target tryptophan hydroxylase, an enzyme that triggers the excess serotonin production within mNET cells that is a key driver of carcinoid syndrome. While existing treatments for carcinoid syndrome work to reduce the release of serotonin outside tumor cells, telotristat ethyl works at the source to reduce serotonin production within the tumor cells. By specifically inhibiting serotonin production, telotristat ethyl seeks to control this important driver of carcinoid syndrome and, in combination with SSA therapy, the current standard of care, to provide patients with more control over their disease.
Telotristat ethyl has received Fast Track and Orphan Drug designation from the U.S. Food and Drug Administration and has been granted priority review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2017.
Lexicon retains rights to market telotristat ethyl 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 ethyl 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 ethyl (formerly referred to as telotristat etiprate and LX1032) and the results of and projected timing of clinical trials and the potential therapeutic and commercial potential of telotristat ethyl. 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 ethyl may be halted, delayed or otherwise not demonstrate safety or efficacy, the risk that the FDA and other regulatory authorities may not grant regulatory approval of telotristat ethyl 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 ethyl. As a result, telotristat ethyl 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.