The Woodlands, Texas, June 19, 2017 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that XERMELO™ (telotristat ethyl) 250 mg has been included as a recommended treatment option in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for neuroendocrine tumors (NET) patients with carcinoid syndrome diarrhea. The NCCN designated XERMELO together with somatostatin analog (SSA) therapy as a category 2A treatment for adults inadequately controlled by SSA therapy. XERMELO has also been included in the NCCN Drugs & Biologics Compendium (NCCN Compendium®).
“XERMELO is the first and only FDA-approved orally administered therapy for the treatment of carcinoid syndrome diarrhea in combination with SSA therapy, representing an important advancement for many NET patients,” said Pablo Lapuerta, M.D., Lexicon’s executive vice president and chief medical officer. “Approval of XERMELO has elevated the importance of managing carcinoid syndrome diarrhea in parallel and separately from treatment of the underlying tumor. We greatly appreciate NCCN’s inclusion of XERMELO in their treatment guidelines, which will help assist patients, their caregivers and their healthcare providers in making informed decisions while treating their NETs.”
XERMELO was approved by the U.S. Food and Drug Administration on February 28, 2017 for the treatment of carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with metastatic NETs (mNETs) and 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. XERMELO targets the overproduction of serotonin inside mNET cells, providing a new treatment option for patients suffering from carcinoid syndrome diarrhea.
About National Comprehensive Cancer Network
The National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 27 of the world’s leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers.
XERMELO™ Important Safety Information
- Warnings and Precautions: XERMELO may cause constipation which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe persistent or worsening abdominal pain develops.
- Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased GGT, depression, peripheral edema, flatulence, decreased appetite, and pyrexia.
- Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure.
For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.
About Lexicon Pharmaceuticals
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. In addition to XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in diabetes and metabolism and neuropathic pain. For additional information please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to the safety and efficacy and therapeutic and commercial potential of XERMELO (telotristat ethyl) 250mg. 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 degree of market acceptance of XERMELO, the availability of coverage and reimbursement for XERMELO, Lexicon’s dependence on third parties for manufacturing and distribution of XERMELO, Lexicon’s compliance with applicable legal and regulatory requirements and other factors relating to the commercialization of XERMELO. 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, 2016, 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.
Kimberly Lee, D.O.
Head of Investor Relations and Corporate Strategy
Senior Director, Corporate Communications and Advocacy