THE WOODLANDS, Texas,
July 21, 2017 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), announced
today that the Committee for Medicinal Products for Human Use
(CHMP), the committee of the European Medicines Agency (EMA)
responsible for human medicines, has adopted a positive opinion for
the Marketing Authorization Application (MAA) filed by Lexicon
collaborator Ipsen for
XERMELO® (telotristat ethyl) 250 mg
to treat carcinoid syndrome diarrhea in combination with
somatostatin analog (SSA) therapy in adults inadequately controlled
by SSA therapy.
The CHMP's recommendation is now referred to the European
Commission (EC), which is expected to render its final decision in
the third quarter of 2017. If approved by the EC, the marketing of
XERMELO will be authorized in all 28 countries of the European
Union (EU), as well as Norway,
Liechtenstein and Iceland.
"XERMELO was approved in the U.S. in February, and the CHMP's
positive opinion marks another important step forward in providing
the first oral treatment option for adults affected by this rare
disease in Europe. We thank the
carcinoid syndrome community for their continued support, including
the adults, families and caregivers who gave their time to
participate in the clinical trials of telotristat ethyl with the
goal of making this treatment a reality for patients," said
Pablo Lapuerta, M.D., executive vice
president and chief medical officer.
Regulatory Submission
The XERMELO MAA was based on two randomized Phase 3 studies,
TELESTAR and TELECAST. The TELESTAR study was a global, pivotal,
double-blind Phase 3 study for telotristat ethyl in 135 patients
from 12 countries with carcinoid syndrome diarrhea whose symptoms
were not adequately controlled on SSA therapy. The primary
objectives were to evaluate the safety and tolerability of
telotristat ethyl and the effectiveness of the drug on the
reduction in the average number of daily bowel movements over a
12-week study period. The TELECAST study was designed similarly to
the TELESTAR study to provide additional efficacy and safety
information in 76 patients with carcinoid syndrome diarrhea. The
primary endpoints were the percent change from baseline in u5-HIAA
at Week 12 and incidence of treatment emergent adverse events
(TEAEs).
In July 2016, the EMA validated
and accepted the MAA to begin the Centralized Procedure.
The CHMP is a scientific committee composed of representatives
from the 28-member states of the EU, as well as Norway, Liechtenstein and Iceland. The committee reviews medical product
applications on their scientific and medicinal merit and provides
advice to the EC, which has the authority to approve medicines for
the EU. The EC is expected to make its final decision on the
XERMELO MAA in the third quarter of
2017.
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. 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.