- Telotristat etiprate, a Phase 3
compound for the treatment of carcinoid syndrome
- Lexicon to potentially receive $145
million in upfront and milestone payments, plus royalties
Regulatory News:
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, comprising $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.
LexiconChas SchultzSenior Director, Finance and
Communications281-863-3421cschultz@lexpharma.comorIpsenMediaDidier
VéronSenior Vice-Président, Public Affairsand CommunicationTel.:
+33 (0)1 58 33 51 16Fax: +33 (0)1 58 33 50 58E-mail:
didier.veron@ipsen.comBrigitte Le GuennecMedia and Public Relations
ManagerTel.: +33 (0)1 58 33 51 17Fax: +33 (0)1 58 33 50 58E-mail :
brigitte.le.guennec@ipsen.comorFinancial CommunityStéphane
Durant des AulnoisInvestor Relations DirectorTel.: +33 (0)1 58 33
60 09Fax: +33 (0)1 58 33 50 63E-mail:
stephane.durant.des.aulnois@ipsen.comThomas Peny-Coblentz,
CFAInvestor Relations Deputy DirectorTel.: +33 (0)1 58 33 56 36Fax:
+33 (0)1 58 33 50 63E-mail: thomas.peny-coblentz@ipsen.com
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