THE WOODLANDS, Texas,
Sept. 7, 2017 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), announced
today that data from four posters highlighting
XERMELO® (telotristat ethyl) will be presented at
the upcoming European Society of Medical Oncology (ESMO) 2017
Congress (September 8-12,
Madrid, Spain).
Additional information on poster details can be found
below and can be accessed at www.esmo.org.
Presentation Details (all times local)
- Sunday, September 10,
1:15pm-2:15pm, poster sessions
-
- "Identifying Symptom and Quality of Life Improvements in
Patients with Carcinoid Syndrome Treated with Telotristat Ethyl:
Qualitative Patient Exit Interviews from the TELESTAR Trial"
(#443P)
- "Relationship between Symptoms and Health-Related Quality of
Life Benefits in Patients with Carcinoid Syndrome: Post-Hoc
Analyses from TELESTAR" (#445P)
- "Long-term Survival of Patients With Carcinoid Syndrome in
Clinical Trials of Telotristat Ethyl" (#442P)
- Monday, September 11,
11:00am-12:00pm, poster
discussion
-
- "Efficacy and Safety of Telotristat Ethyl in Patients With
Carcinoid Syndrome Inadequately Controlled by Somatostatin Analogs:
Analysis of the Completed TELESTAR Extension Period" (#440-PD)
About XERMELO (Telotristat Ethyl)
Discovered using Lexicon's unique approach to gene science,
XERMELO (telotristat ethyl) is the first and only approved oral
therapy for carcinoid syndrome diarrhea in combination with
somatostatin analog (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. 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 its first commercial product,
XERMELO® (telotristat ethyl) for carcinoid
syndrome diarrhea, 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.