PARIS and THE WOODLANDS, Texas, Nov. 6, 2015 /PRNewswire/ -- Sanofi
(EURONEXT: SAN and NYSE: SNY) and Lexicon Pharmaceuticals, Inc.
(NASDAQ: LXRX) announced today that they have entered into a
collaboration and license agreement for the development and
commercialization of sotagliflozin, an investigational new oral
dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT-1 and
SGLT-2), which could be a potential treatment option for people
with diabetes.
"This agreement with Lexicon reinforces our commitment to
helping people living with diabetes," said Pascale Witz, Executive Vice President, Sanofi,
who will lead the Global Diabetes and Cardiovascular Care Business
Unit in the company's new organizational structure. "Adding
sotagliflozin to our portfolio, which includes medicines at
virtually every stage of the treatment pathway, highlights our
focus on providing a large and diverse set of therapeutic options
for people with this disease."
The developmental medicine sotagliflozin (LX4211) is currently
being studied in two pivotal Phase 3 trials in type 1 diabetes,
which are expected to report top-line results during the second
half of 2016. Phase 3 trials in type 2 diabetes are expected to
begin in 2016. Sotagliflozin has previously shown encouraging
results in exploratory (Phase 2) studies, including reduction of
blood sugar (HbA1c), improvement in glycemic variability
and reduced meal-time insulin dose compared with placebo in type 1
diabetics. Phase 2 studies exploring treatment in people with type
2 diabetes, including those with renal impairment, showed lowering
of blood sugar (HbA1c), weight loss and blood pressure
improvements. No increase in hypoglycemic events was seen with
sotagliflozin compared to background therapy in the Phase 2
program. The adverse event profile in the Phase 2 program was
similar to other products in this class and reflective of the
urinary glucose excretion associated with sotagliflozin's
inhibition of SGLT-2.
These results indicate that sotagliflozin could have the
potential to become an important option among oral anti-diabetic
medicines and provide a strong rationale for the further
investigation of this compound as a treatment for people with
diabetes.
"Lexicon firmly believes in the potential of sotagliflozin for
patients living with diabetes. It has been our strategy to focus
our resources on the development of sotagliflozin for type 1
diabetes and to pursue a strategic partnership with respect to type
2 diabetes only if it would strengthen stakeholder value under a
fully integrated diabetes program. We believe this arrangement with
Sanofi achieves that objective," said Lexicon President and Chief
Executive Officer Lonnel Coats.
"Sanofi's patient-centric focus in diabetes, and its rich history
of innovation in diabetes, make it an exceedingly attractive
partner which is well positioned to unlock the full potential of
sotagliflozin for patients living with diabetes. Also consistent
with our strategy, Lexicon will continue to lead the development of
sotagliflozin for type 1 diabetes and have rights to participate in
the commercialization of sotagliflozin for type 1 diabetes in
the United States."
Under the terms of the agreement, Lexicon will receive an
upfront payment of $300 million and
is eligible to receive development, regulatory and sales milestone
payments of up to $1.4 billion.
Lexicon is also entitled to tiered, escalating double digit
percentage royalties on net sales of sotagliflozin.
Sanofi obtains an exclusive worldwide license to develop,
manufacture and commercialize sotagliflozin. Lexicon will continue
to be responsible for all clinical development activities relating
to type 1 diabetes and will retain an exclusive option to
co-promote and have a significant role, in collaboration with
Sanofi, in the commercialization of sotagliflozin for the treatment
of type 1 diabetes in the United
States. Sanofi will be responsible for all clinical
development and commercialization activities of sotagliflozin for
the treatment of type 2 diabetes worldwide and will be solely
responsible for the commercialization of sotagliflozin for the
treatment of type 1 diabetes outside the United States.
Lexicon will share in the funding of a portion of the planned type
2 diabetes development costs over the next three years, up to an
aggregate of $100 million.
The agreement is subject to customary filing and review under
the Hart-Scott-Rodino Antitrust Improvements Act.
The investigational agent described above is currently under
clinical development and its safety and efficacy have not been
evaluated by any regulatory authority.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients' needs.
Sanofi has core strengths in the field of healthcare with seven
growth platforms: diabetes solutions, human vaccines, innovative
drugs, consumer healthcare, emerging markets, animal health and the
new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Lexicon
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 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.
Lexicon has a pipeline of promising drug candidates in clinical and
pre-clinical development in oncology, diabetes and metabolism. For
additional information please visit www.lexpharma.com.
Forward Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
historical facts. These statements include projections and
estimates and their underlying assumptions, statements regarding
plans, objectives, intentions and expectations with respect to
future financial results, events, operations, services, product
development and potential, and statements regarding future
performance. Forward-looking statements are generally identified by
the words "expects", "anticipates", "believes", "intends",
"estimates", "plans" and similar expressions. Although Sanofi's and
Lexicon's management believes that the expectations reflected in
such forward-looking statements are reasonable, investors are
cautioned that forward-looking information and statements are
subject to various risks and uncertainties, many of which are
difficult to predict and generally beyond the control of Sanofi and
Lexicon, that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and
uncertainties include among other things, the uncertainties
inherent in research and development, including the timing of
clinical trials, the uncertain predictive nature of clinical trials
with respect to subsequent clinical trials, future clinical data
and analysis, including post marketing, decisions by regulatory
authorities, such as the FDA or the EMA, regarding whether and when
to approve any drug, device or biological application that may be
filed for any such product candidates as well as their decisions
regarding labelling and other matters that could affect the
availability or commercial potential of such product candidates,
the absence of guarantee that the product candidates if approved
will be commercially successful, the future approval and commercial
success of therapeutic alternatives, Sanofi's and Lexicon's ability
to benefit from external growth opportunities, trends in exchange
rates and prevailing interest rates, the impact of cost containment
policies and subsequent changes thereto, as well as those risks and
uncertainties discussed or identified in the public filings with
the SEC and the AMF made by Sanofi and with the SEC made by
Lexicon, including those listed under "Risk Factors" and
"Cautionary Statement Regarding Forward-Looking Statements" in
Sanofi's annual report on Form 20-F and in Lexicon's annual report
on Form 10-K for the year ended December 31,
2014. Other than as required by applicable law, Sanofi and
Lexicon do not undertake any obligation to update or revise any
forward-looking information or statements.
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SOURCE Lexicon Pharmaceuticals, Inc.; Sanofi