THE WOODLANDS, Texas,
Feb. 28, 2017 /PRNewswire/ -- Lexicon
Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that the U.S.
Food and Drug Administration (FDA) 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[i]. Carcinoid syndrome is a
rare and debilitating condition that affects people with metastatic
neuroendocrine tumors (mNETs)[ii]. XERMELO targets the
overproduction of serotonin inside mNET cells[iii], providing a new
treatment option for patients suffering from carcinoid syndrome
diarrhea. This new treatment is now available by prescription and
will be in select specialty pharmacies beginning March 6, 2017.
"Today's approval of XERMELO represents a shift in the treatment
paradigm of carcinoid syndrome diarrhea for cancer patients who are
inadequately controlled by SSA therapy, and until now, have had
limited options to manage this debilitating condition," said
Lonnel Coats, Lexicon's president
and chief executive officer. "We are proud to have discovered and
developed this ground-breaking orphan drug, and it is an honor to
make it available for the thousands of patients currently suffering
from this condition who wish to lead a more routine life with fewer
incidences of severe diarrhea."
Carcinoid syndrome is a rare condition that occurs in patients
living with mNETs[iv] 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.
"The approval of XERMELO establishes a new treatment option for
patients with carcinoid syndrome diarrhea that is inadequately
controlled by SSA therapy," said Matthew H.
Kulke, M.D., TELESTAR primary investigator, director of the
Program in Neuroendocrine and Carcinoid Tumors at Dana Farber
Cancer Institute and Professor of Medicine, Harvard Medical
School. "Inhibition of tumoral serotonin production
represents a novel approach for patients with this condition.
Studies have shown that XERMELO can reduce the debilitating effects
of carcinoid syndrome diarrhea and has a favorable efficacy and
safety profile in patients who currently have limited treatment
options."
About XERMELO™
Discovered using Lexicon's unique approach to gene science,
XERMELO is the first and only approved oral therapy for carcinoid
syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an
enzyme that mediates the excess serotonin production within 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 telotristat ethyl in Japan.
Lexicon has established a license and collaboration agreement
with Ipsen to commercialize telotristat ethyl in Europe and other countries outside of U.S. and
Japan. For more information about XERMELO, please visit
www.xermelo.com.
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.
Lexicon Conference Call
Lexicon management will hold a conference call to discuss the
approval of XERMELO at 5:00 pm Eastern
Time today, February 28,
2017. The dial-in number for the conference call is
888-645-5785 (within the US/Canada) or 970-300-1531 (international).
The conference ID for all callers is 78166536. Investors can
access a live webcast of the call at www.lexpharma.com. An
archived version of the webcast will be available on the website
through March 31, 2017.
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. 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.
In an effort to ensure all appropriate patients have fast access
to affordable treatment, Lexicon offers LexCares—a comprehensive
program designed to guide patients through each step of their
treatment journey. Through LexCares, patients will have access to
financial assistance programs that may reduce or eliminate
out-of-pocket costs associated with their XERMELO prescription. For
additional information about the LexCares program, visit
www.xermelo.com/lexcares.
Safe Harbor Statement
This press release contains "forward‑looking
statements," including statements relating to the safety and
efficacy and the therapeutic and commercial potential of XERMELO
(telotristat ethyl) 250 mg. 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, 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.
[i] Data on file – XERMELO label. Lexicon Pharmaceuticals, Inc.
2017.
[ii] National Organization for Rare Disorders. Carcinoid Syndrome.
Retrieved from:
https://rarediseases.org/rare-diseases/carcinoid-syndrome/.
Accessed November 22, 2016.
[iii] Data on file. Lexicon Pharmaceuticals, Inc. 2017.
[iv] Rorstad O. Prognostic indicators for carcinoid neuroendocrine
tumors of the gastrointestinal tract. J Surg Oncol. 2005;
89(3):151-60.
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SOURCE Lexicon Pharmaceuticals, Inc.