The Woodlands, Texas, November 21, 2016 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced the appointments of Alexander Santini as chief commercial officer, Kiernan Seth, Ph.D. as vice president of marketing, and Gary Branch as vice president of sales. Mr. Santini will have responsibility for all commercial activities in the United States for telotristat ethyl, an investigational oral drug for the treatment of carcinoid syndrome, with Dr. Seth and Mr. Branch reporting directly to him.
“We are pleased to have the core members of the commercial leadership team in place leading into the potential commercialization of telotristat ethyl,” said Lexicon president and chief executive officer, Lonnel Coats. “Each member of this unique team brings a tremendous level of expertise that will be crucial in ensuring that telotristat ethyl, if approved, is immediately accessible for patients suffering from carcinoid syndrome.”
With over 30 years of varied health care experience, Mr. Santini has demonstrated the ability to build, lead and motivate cross functional teams responsible for driving successful product launches and customer service improvements, while building strategic partnerships with key decision makers. Mr. Santini joined Lexicon in April 2015 and was previously responsible for developing the market access and channel management strategy for telotristat ethyl. Prior to joining Lexicon, Mr. Santini served as executive member and vice president of market access for the Bayer U.S. Pharmaceutical organization where he had executive responsibility for market access, pricing, trade and channel management, and payer account management for the entire Bayer U.S. drug portfolio. Prior to Bayer Pharmaceuticals, Mr. Santini held executive leadership roles of increasing responsibility at Berlex Laboratories. Prior to embarking on his career in the pharmaceutical industry, Mr. Santini served as a non-commissioned officer in the U.S. Air Force, where he completed the Radiologic Technology Program at the U.S. Air Force School of Health Care Science and an AAS degree in Business Marketing from Westchester Community College in Valhalla, New York. During his tour of duty Alex was awarded the Certificate of Appreciation from the U.S. Secretary of Defense for exemplary outstanding performance of duties in support of the 1980 XIII Olympic Winter Games, Lake Placid, New York.
Dr. Seth joined Lexicon in November 2014 as executive director of oncology marketing. As vice president of marketing, he will be responsible for leading the marketing efforts for telotristat ethyl while ensuring Lexicon’s commercial readiness. Dr. Seth brings to Lexicon more than 20 years of experience, most recently at Eisai, Inc. where he served as executive director of Eisai value maximization systems and head of the oncology business unit. Before joining Eisai, Dr. Seth served in a series of marketing roles with Bristol-Myers Squibb, Pfizer and Schering-Plough involving products in oncology, cardiovascular and metabolic disease, immunology and central nervous system disorders. He received his Ph.D. from Meharry Medical College and MBA from St. Joseph’s University and completed a Post Doctoral Fellowship at Harvard Medical School.
Mr. Branch joined Lexicon in March 2016 with the responsibility of leading the sales effort for telotristat ethyl and building the sales function, including the sales team, sales operations, and sales training. He has over 24 years of commercial experience in the pharmaceutical industry with a deep breadth of experiences in both oncology and general pharmaceuticals including key roles as vice president of sales at GlaxoSmithKline Oncology, vice president of sales at Novartis Canada, and global brand director at Novartis Oncology. Prior to embarking on his career in the pharmaceutical industry, Gary served with distinction as captain in the U.S. Army, where he was awarded and recognized for performance in combat during Operations Desert Shield and Desert Storm. Gary has a BS degree in General Engineering from the United States Military Academy in West Point, NY, and an MBA from the University of Michigan Business School in Ann Arbor, MI.
“I am very excited to be leading the commercial team at this crucial juncture, and look forward to making telotristat ethyl commercially available to carcinoid syndrome patients following regulatory approval,” said Mr. Santini. “I look forward to working with the executive team to achieve our vision of developing and commercializing innovative medications to address the needs of patients, physicians, and payers.”
About Carcinoid Syndrome
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 by facial flushing, abdominal pain, fatigue and, over time, heart valve damage.
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.