-- Lexicon eligible for an additional $5 million in up-front and pre-commercial
milestone payments for Canadian rights, plus royalties and sales
milestones under original agreement
-- Lexicon retains all commercialization rights in the U.S.
and Japan
THE WOODLANDS, Texas and
BASKING RIDGE, N.J., March
18, 2015 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc.
(Nasdaq: LXRX) and Ipsen S.A. (Euronext: IPN; ADR: IPSEY) today
announced that they have entered into an agreement for Ipsen, upon
regulatory approval, to commercialize telotristat etiprate in
Canada, with a focus on the
treatment of carcinoid syndrome. This agreement represents an
expansion of the licensing agreement previously entered into by
Ipsen and Lexicon in October 2014.
Under the expanded alliance, Lexicon retains sole rights to
commercialize telotristat etiprate in the
United States and Japan.
Lexicon is conducting Phase 3 clinical trials of telotristat
etiprate, an investigational treatment 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 the third quarter of 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 SSA therapy. Lexicon recently announced the completion of
enrollment in the pivotal trial. Lexicon will continue to be
responsible for the potential registration of telotristat etiprate
in the U.S. and Japan, while
Lexicon and Ipsen will collaborate to seek regulatory approvals in
Europe, Canada and other countries within the Ipsen
licensed territory, with Ipsen assuming the lead responsibility in
those markets.
"The expansion of our collaboration with Ipsen to include
Canada provides the opportunity to
create added value for Lexicon while adding greater focus to our
own commercialization plans for telotristat etiprate in
the United States," said
Jeffrey Wade, Lexicon's Executive
Vice President and Chief Financial Officer. "Ipsen is a
leader in the treatment of neuroendocrine tumors, including
carcinoid syndrome. Ipsen's North American expansion, based on the
strength of its oncology franchise, offered us the opportunity to
expand our collaboration to Canada
while maintaining Lexicon's core strategy of maintaining
commercialization rights in the U.S. market. The license expansion
is a testament to the strength of the collaboration between Lexicon
and Ipsen, and to the value both companies place on telotristat
etiprate for carcinoid syndrome."
Cynthia Schwalm, President and
Chief Executive Officer of Ipsen Biopharmaceuticals stated:
"This amendment to Ipsen's previously announced agreement with
Lexicon will further our goal of becoming a leading specialty
pharmaceutical company in North
America." Cynthia
Schwalm added: "The agreement also builds on our
expertise in, and commitment to, oncology and the treatment of
neuroendocrine and carcinoid tumors where there remains a
tremendous need for additional therapeutic options for patients and
their healthcare providers."
Under the financial terms of the agreement, Lexicon is eligible
to receive up to $5 million in
upfront and pre-commercialization milestones. Net sales in
Canada will be aggregated with
those in Europe and other
territories licensed to Ipsen for purposes of the royalties and
sales milestones to be paid to Lexicon under the
agreement.
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
2014. 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 urology-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 2014, R&D expenditure totaled close to €187 million,
representing about 15% of Group sales. Moreover, Ipsen also has a
significant presence in primary care. The Group has more than 4,500
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 Reglement Differe" ("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, 2014, 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 Autorite des Marches
Financiers.
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visit:http://www.prnewswire.com/news-releases/lexicon-and-ipsen-expand-their-licensing-and-commercialization-agreement-for-telotristat-etiprate-to-include-canada-300052343.html
SOURCE Lexicon Pharmaceuticals, Inc.
