PARIS and THE WOODLANDS, Texas, Oct. 22, 2014
/PRNewswire/ -- Ipsen (Euronext: IPN; ADR: IPSEY) and Lexicon
Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that they have
entered into an exclusive licensing agreement for Ipsen to
commercialize telotristat etiprate outside of North America and Japan, with a focus on the treatment of
carcinoid syndrome. Lexicon retains sole rights to commercialize
telotristat etiprate in the United
States, Canada and
Japan.
Lexicon is conducting Phase 3 clinical trials of telotristat
etiprate for carcinoid syndrome, a serious condition caused by
symptomatic neuroendocrine tumors, which produce large amounts of
serotonin. Carcinoid syndrome is characterized by severe diarrhea,
flushing and, in some cases, heart valve damage. Telotristat
etiprate is an oral, small-molecule inhibitor of tryptophan
hydroxylase (TPH) that reduces peripheral serotonin production
without affecting brain serotonin levels. Telotristat etiprate has
received fast track status and orphan drug designation from the
Food and Drug Administration in the
United States, and has received orphan drug designation from
the European Medicines Agency.
Lexicon will continue to lead the global Phase 3 clinical
program for telotristat etiprate in carcinoid syndrome, from which
data are expected in 2015. The pivotal Phase 3 trial is comparing
telotristat etiprate to placebo on a background of somatostatin
analog (SSA) therapy, the current standard of care, in patients
whose carcinoid syndrome is not adequately controlled with
lanreotide or octreotide. The clinical Phase 3 study is recruiting
in approximately 70 centers worldwide. Lexicon will continue to be
responsible for the potential registration of telotristat etiprate
in the U.S., Canada and
Japan, while Lexicon and Ipsen
will collaborate to seek regulatory approvals in Europe and other countries within the Ipsen
licensed territory, with Ipsen assuming the lead responsibility in
those markets.
"This collaboration with Ipsen provides the opportunity to
create added value for Lexicon and more effectively commercialize
telotristat etiprate in markets around the world," said
Lonnel Coats, Lexicon's President
and Chief Executive Officer. "Ipsen is a leader in the
treatment of carcinoid syndrome and neuroendocrine tumors with
Somatuline® (lanreotide). Lexicon will benefit
commercially from Ipsen's substantial market presence in
Europe and other countries in the
licensed territory, and will benefit globally from coordination
with Ipsen on medical and scientific matters. This agreement
represents an important achievement for Lexicon as we continue to
execute on a strategy to translate our discoveries into
life-changing products for patients in important areas of unmet
medical need."
Marc de Garidel, Chairman and
Chief Executive Officer of Ipsen stated: "Ipsen is delighted
to enter into a partnership with Lexicon in Europe and other countries. The
CLARINET® study with Somatuline® (lanreotide)
paved the way for a change in the treatment paradigm for pancreatic
and gastro intestinal NET patients. Upon approval, telotristat
etiprate will enlarge our footprint in the symptomatic management
of NET and offer important benefits to patients with carcinoid
syndrome." Marc de
Garidel added: "This agreement reflects our
strategy to strengthen our presence in the fields of oncology,
endocrinology and neurology, which will continue to be supported by
our newly signed five-year multi-currency €500 million revolving
credit facility."
Under the financial terms of the agreement, Lexicon is eligible
to receive up to $145 million,
comprised of a $23 million upfront payment and additional
payments contingent upon achievement of clinical, regulatory and
commercial milestones. In addition, Lexicon is also eligible to
receive royalties on net sales of telotristat etiprate in the
licensed territory.
About carcinoid syndrome
Neuroendocrine neoplasms are
tumors arising from the diffuse neuroendocrine system most often
along the gastrointestinal tract. They are rare but their incidence
is increasing (approximately 2.5 to 4.5 new cases diagnosed per
100,000 persons per year). They constitute a heterogeneous group of
tumors with location of the primary tumor in the gastric mucosa,
pancreas, small and large intestine. As a result of their origin,
they are capable of releasing a variety of hormones and
neuroamines, most commonly serotonin, which, when released into the
systemic circulation, can cause distinct clinical symptoms, such as
the carcinoid syndrome associating diarrhea and flushing, with
often abdominal pain. In some cases, digestive disorders and
flushing are associated with heart failure (wheezing, edema of the
lower limbs, irregular heartbeats) indicator of carcinoid valvular
heart disease.
Lexicon Conference Call
Lexicon management will hold a
conference call at 8:30 a.m. Eastern Time on October
22, 2014. 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 11632. 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 November
22, 2014.
About Lexicon
Lexicon is a biopharmaceutical company
focused on developing breakthrough treatments for human disease.
Lexicon has clinical-stage drug programs for diabetes, carcinoid
syndrome, and other indications, all of which were discovered by
Lexicon's research team. Lexicon has used its proprietary gene
knockout technology to identify more than 100 promising drug
targets. For additional information about Lexicon and its programs,
please visit www.lexpharma.com.
About Ipsen
Ipsen is a global specialty-driven
pharmaceutical company with total sales exceeding €1.2 billion in
2013. Ipsen's ambition is to become a leader in specialty
healthcare solutions for targeted debilitating diseases. Its
development strategy is supported by 3 franchises: neurology,
endocrinology and uro-oncology. Moreover, the Group has an active
policy of partnerships. Ipsen's R&D is focused on its
innovative and differentiated technological platforms, peptides and
toxins. In 2013, R&D expenditure totaled close to €260 million,
representing more than 21% of Group sales. Moreover, Ipsen also has
a significant presence in primary care. The Group has close to
4,600 employees worldwide. Ipsen's shares are traded on segment A
of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and
eligible to the "Service de Règlement Différé" ("SRD"). The Group
is part of the SBF 120 index. Ipsen has implemented a Sponsored
Level I American Depositary Receipt (ADR) program, which trade on
the over-the-counter market in the United
States under the symbol IPSEY. For more information on
Ipsen, visit www.ipsen.com.
Lexicon Forward Looking Statements
This press release
contains "forward-looking statements," including statements
relating to Lexicon's clinical development of telotristat etiprate,
characterizations of the results of and projected timing of
clinical trials of telotristat etiprate, and the potential
therapeutic and commercial potential of telotristat etiprate.
The 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 those relating to Lexicon's ability to meet its capital
requirements, successfully conduct clinical development of
telotristat etiprate and preclinical and clinical development of
its other potential drug candidates, advance additional candidates
into preclinical and clinical development, obtain necessary
regulatory approvals, 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, that 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, 2013, 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 Statements
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.
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SOURCE Lexicon Pharmaceuticals, Inc.