European Commission Approves XERMELO® (Telotristat Ethyl) For The Treatment Of Carcinoid Syndrome Diarrhea In Combination With Somatostatin Analog Therapy

THE WOODLANDS, Texas, Sept. 19, 2017 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), announced today that the European Commission has approved XERMELO^® (telotristat ethyl) 250 mg as a first and only orally administered therapy for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. This approval allows for the marketing of XERMELO by Lexicon's collaborator, Ipsen, in the above indication in all 28 member states of the European Union, Norway and Iceland. Carcinoid syndrome is a rare and debilitating condition that affects people with metastatic neuroendocrine tumors (mNETs). XERMELO targets the overproduction of serotonin inside mNET cells, providing a new treatment option for patients suffering from carcinoid syndrome diarrhea.

"The approval of XERMELO in Europe underscores the terrible nature of the disease and the significant impact that XERMELO can provide to thousands of European patients living with carcinoid syndrome diarrhea," said Lonnel Coats, Lexicon's president and chief executive officer. "We are pleased that this regulatory approval in Europe marks the first oral treatment option for patients with this disease. I would like to thank the investigators, patients and families who participated in the clinical trials that led to this approval."

"Today's approval marks an inflection point for patients and their families in Europe who have waited a long time for a novel treatment option for carcinoid syndrome diarrhea," said Kjell Oberg, M.D., Ph.D., Professor of Endocrine Oncology, Chairman Centre of Excellence Endocrine Tumors, Uppsala University Hospital. "In the TELESTAR and TELECAST studies, XERMELO safely reduced the debilitating effects of carcinoid syndrome diarrhea and significantly improved the quality of life for these patients."

"On behalf of the international neuroendocrine patient community, we would like to thank the European Commission for their diligence and commitment to bringing new therapies to patients who suffer on a daily basis from neuroendocrine tumors," said Teodora Kolarova, Executive Director of the International Neuroendocrine Cancer Alliance (INCA). "The approval of XERMELO ensures that patients throughout Europe will continue to have access to the newest treatment options available."

About XERMELO (Telotristat Ethyl)

Discovered using Lexicon's unique approach to gene science, XERMELO (telostristat ethyl) is the first and only approved oral therapy for carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSAs. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. Lexicon has built the in-house capability and infrastructure to launch and market XERMELO in the U.S., where it retains all commercialization rights.  Lexicon also retains rights to market XERMELO in Japan. Lexicon has established a license and collaboration agreement with Ipsen to commercialize XERMELO in Europe and other countries outside of U.S. and Japan.

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. Shortly after approval, XERMELO was included in the National Comprehensive Cancer Network (NCCN) and the North American Neuroendocrine Tumor Society (NANETS) guidelines. Carcinoid syndrome is a rare condition that occurs in patients living with metastatic NETs (mNETs) and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing a new treatment option for patients suffering from carcinoid syndrome diarrhea.

XERMELO (Telotristat Ethyl) 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 gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
• Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

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.

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SOURCE Lexicon Pharmaceuticals, Inc.