THE WOODLANDS, Texas,
July 31, 2017 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today
announced that it has exercised its option under its collaboration
and license agreement with Sanofi to co-promote sotagliflozin, an
investigational oral dual inhibitor of sodium-glucose
cotransporters 1 and 2 (SGLT-1 and SGLT-2), for the treatment of
type 1 diabetes in the U.S. The opt-in decision was based on
positive data from three Phase 3 studies, inTandem1, inTandem2, and
inTandem3 and is aligned to a planned regulatory filing in the
U.S.
"This marks another milestone for this collaboration and is a
meaningful step forward on the path to bringing a novel and
first-in-class therapy to patients with type 1 diabetes. This
decision allows us to play a significant role in the
commercialization of sotagliflozin, if the medicine is approved by
the FDA," said Jeffrey L. Wade, JD,
Lexicon's executive vice president, corporate and administrative
affairs and chief financial officer. "As we near completion of the
type 1 diabetes development program for sotagliflozin, we look
forward to additional sotagliflozin clinical data this quarter and
presentations at the upcoming EASD meeting in September."
"Sotagliflozin is an important and innovative investigational
medicine for the treatment of type 1 diabetes," said Stefan Oelrich, Senior Vice President and Head,
Global Diabetes Franchise, Sanofi. "People with this disease have
few treatment options, and their unmet need for oral medications
that can be used with insulin is high. We are pleased with
Lexicon's election to exercise its option to co-promote this
product in the U.S., if approved."
Sanofi intends to file applications in the first half of 2018
for the EU and U.S. regulatory reviews of sotagliflozin for the
treatment of type 1 diabetes, pending the full read out of Phase 3
data.
Collaboration Background
In November 2015, Lexicon and
Sanofi entered into a collaboration and license agreement for the
development and commercialization of sotagliflozin. Under the terms
of the agreement, Lexicon received 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.
Under the collaboration, Lexicon granted Sanofi an exclusive
worldwide (excluding Japan)
license to develop, manufacture and commercialize sotagliflozin.
Lexicon is responsible for all clinical development activities
relating to type 1 diabetes. Sanofi is responsible for all clinical
development and commercialization activities of sotagliflozin for
the treatment of type 2 diabetes worldwide and is solely
responsible for the commercialization of sotagliflozin for the
treatment of type 1 diabetes outside the U.S. 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.
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.
Safe Harbor Statement
This press release contains "forward-looking statements,"
including statements relating to Lexicon's and its licensees'
clinical development of and regulatory filings for sotagliflozin
and the results and projected timing of clinical trials and the
potential therapeutic and commercial potential of sotagliflozin. 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 risk that clinical studies of
sotagliflozin may be halted, delayed or otherwise not demonstrate
safety or efficacy, the risk that the FDA and other regulatory
authorities may not grant regulatory approval of sotagliflozin in
accordance with Lexicon's currently anticipated timelines or at
all, and the risk that such regulatory approvals, if granted, may
have significant limitations on the approved use of sotagliflozin.
As a result, sotagliflozin may never be successfully
commercialized. 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, 2016, 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.
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SOURCE Lexicon Pharmaceuticals, Inc.