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.