Approval Enables Availability of First-in-Class
Oral Tryptophan Hydroxylase Inhibitor that Sustains Improvement of
Carcinoid Syndrome Diarrhea in Adults Inadequately Controlled by
Somatostatin Analogs Alone
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), and Ipsen
Biopharmaceuticals Canada Inc. announced today that Health Canada
has approved XERMELO® (telotristat ethyl) 250 mg as a first and
only orally administered therapy for the treatment of refractory
carcinoid syndrome diarrhea in combination with somatostatin analog
(SSA) therapy in patients inadequately controlled by SSA therapy
alone. This approval allows for the marketing of XERMELO by
Lexicon’s collaborator, Ipsen, in the above indication in Canada.
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.
“Today’s approval of XERMELO in Canada
underscores the need for a new therapy to treat refractory
carcinoid syndrome diarrhea and the significant impact that XERMELO
can provide to many Canadian patients living with this debilitating
disease,” said Lonnel Coats, Lexicon’s president and chief
executive officer. “I would like to thank the investigators,
patients, families and caregivers who participated in the clinical
trials that led to this approval.”
“Health Canada’s approval of XERMELO is a
further demonstration of our and Lexicon’s commitment to bringing
new, innovative therapies for difficult-to-treat diseases and for
patients faced with limited options in Canada,” said Ed Dybka,
General Manager for Ipsen Biopharmaceuticals Canada Inc. “We look
forward to making XERMELO available to patients with refractory
carcinoid syndrome diarrhea across Canada.”
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 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 and by the European Commission
on September 19, 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 an additional 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), 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.
About Ipsen
Ipsen Biopharmaceuticals Canada Inc., the
Canadian affiliate of Ipsen, is headquartered in Mississauga,
Ontario with established operations since October 2015. For more
information on Ipsen Biopharmaceuticals Canada Inc. visit
www.ipsen.ca. Ipsen is a global specialty-driven biopharmaceutical
group focused on innovation and specialty care. The group develops
and commercializes innovative medicines in three key therapeutic
areas – Oncology, Neuroscience and Rare Diseases. Its commitment to
Oncology is exemplified through its growing portfolio of key
therapies for prostate cancer, neuroendocrine tumors, renal cell
carcinoma and pancreatic cancer. Ipsen’s R&D is focused on its
innovative and differentiated technological platforms located in
the heart of the leading biotechnological and life sciences hubs
(Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has
about 5,400 employees worldwide. Ipsen is listed in Paris
(Euronext: IPN) and in the United States through a Sponsored Level
I American Depositary Receipt program (ADR: IPSEY). For more
information on Ipsen, visit www.ipsen.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) 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, 2017, 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.
Ipsen Forward Looking
Statement
The forward-looking statements, objectives and
targets contained herein are based on the Group’s management
strategy, current views and assumptions. Such statements involve
known and unknown risks and uncertainties that may cause actual
results, performance or events to differ materially from those
anticipated herein. All of the above risks could affect the Group’s
future ability to achieve its financial targets, which were set
assuming reasonable macroeconomic conditions based on the
information available today. Use of the words "believes,"
"anticipates" and "expects" and similar expressions are intended to
identify forward-looking statements, including the Group’s
expectations regarding future events, including regulatory filings
and determinations. Moreover, the targets described in this
document were prepared without taking into account external growth
assumptions and potential future acquisitions, which may alter
these parameters. These objectives are based on data and
assumptions regarded as reasonable by the Group. These targets
depend on conditions or facts likely to happen in the future, and
not exclusively on historical data. Actual results may depart
significantly from these targets given the occurrence of certain
risks and uncertainties, notably the fact that a promising product
in early development phase or clinical trial may end up never being
launched on the market or reaching its commercial targets, notably
for regulatory or competition reasons. The Group must face or might
face competition from generic products that might translate into a
loss of market share. Furthermore, the Research and Development
process involves several stages each of which involves the
substantial risk that the Group may fail to achieve its objectives
and be forced to abandon its efforts with regards to a product in
which it has invested significant sums. Therefore, the Group cannot
be certain that favourable results obtained during pre-clinical
trials will be confirmed subsequently during clinical trials, or
that the results of clinical trials will be sufficient to
demonstrate the safe and effective nature of the product concerned.
There can be no guarantees a product will receive the necessary
regulatory approvals or that the product will prove to be
commercially successful. If underlying assumptions prove inaccurate
or risks or uncertainties materialize, actual results may differ
materially from those set forth in the forward-looking statements.
Other risks and uncertainties include but are not limited to,
general industry conditions and competition; general economic
factors, including interest rate and currency exchange rate
fluctuations; the impact of pharmaceutical industry regulation and
health care legislation; global trends toward health care cost
containment; technological advances, new products and patents
attained by competitors; challenges inherent in new product
development, including obtaining regulatory approval; the Group's
ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of
international economies and sovereign risk; dependence on the
effectiveness of the Group’s patents and other protections for
innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions. The Group also
depends on third parties to develop and market some of its products
which could potentially generate substantial royalties; these
partners could behave in such ways which could cause damage to the
Group’s activities and financial results. The Group cannot be
certain that its partners will fulfil their obligations. It might
be unable to obtain any benefit from those agreements. A default by
any of the Group’s partners could generate lower revenues than
expected. Such situations could have a negative impact on the
Group’s business, financial position or performance. The Group
expressly disclaims any obligation or undertaking to update or
revise any forward-looking statements, targets or estimates
contained in this press release to reflect any change in events,
conditions, assumptions or circumstances on which any such
statements are based, unless so required by applicable law. The
Group’s business is subject to the risk factors outlined in its
registration documents filed with the French Autorité des Marchés
Financiers.
The risks and uncertainties set out are not
exhaustive and the reader is advised to refer to the Group’s 2017
Registration Document available on its website (www.ipsen.com).
For Investor Inquiries:Kimberly
Lee, D.O.Head of Investor Relations and Corporate StrategyLexicon
Pharmaceuticals(281) 863-3383klee@lexpharma.com
For Media Inquiries:Chas
SchultzExecutive Director, Corporate Communications and
AdvocacyLexicon Pharmaceuticals(281)
863-3421cschultz@lexpharma.com
Marisol PeronIpsen
BiopharmaceuticalsMarisol.peron@ipsen.com(908) 275-6330
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