THE WOODLANDS, Texas,
Sept. 14, 2016 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today
announced that the U.S. Food and Drug Administration ("FDA") will
require additional time to complete its review of the New Drug
Application ("NDA") for telotristat etiprate, an oral drug for the
treatment of carcinoid syndrome. In a notice received from
the FDA, the Prescription Drug User Fee Act ("PDUFA") date for its
Priority Review of telotristat etiprate has been extended by three
months, from November 30, 2016 to
February 28, 2017. In response
to an information request from the FDA, additional clinical data
analyses have been submitted and the extension will provide the FDA
time for a full review of the submission.
"We look forward to continuing to work closely with the FDA
throughout the remainder of the regulatory review of telotristat
etiprate," said Lexicon President and Chief Executive Officer,
Lonnel Coats. "We appreciate
the efforts of the FDA to conduct a complete review of all of the
data supporting our NDA and we are committed to bringing this
potential new therapy to patients suffering from 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 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 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 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.
About Lexicon
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 and its licensees'
clinical development of and regulatory filings for telotristat
etiprate (LX1032) and the results 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 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.