The U.S. Food and Drug Administration (FDA) issued a Complete
Response Letter (CRL) regarding the New Drug Application for
investigational Zynquista™ (sotagliflozin)*, a dual SGLT1 and
SGLT2 inhibitor for the treatment of adults with type 1 diabetes in
combination with insulin.
A CRL is a communication from the FDA that
informs companies that an application cannot be approved in its
present form.
Sanofi and Lexicon will work closely with the
FDA to determine the appropriate next steps.
* Sotagliflozin is an investigational drug and
is under regulatory review by the European Medicines Agency (EMA)
and U.S. Food and Drug Administration (FDA). The EMA and FDA have
conditionally accepted Zynquista™ as the trade name for
sotagliflozin.
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.
About Sanofi
Sanofi is dedicated to supporting people through
their health challenges. We are a global biopharmaceutical company
focused on human health. We prevent illness with vaccines, provide
innovative treatments to fight pain and ease suffering. We stand by
the few who suffer from rare diseases and the millions with
long-term chronic conditions.
With more than 100,000 people in 100 countries,
Sanofi is transforming scientific innovation into healthcare
solutions around the globe.
Sanofi, Empowering Life
Lexicon Forward-Looking
Statements
This press release contains “forward-looking
statements,” including statements relating to Lexicon’s and
Sanofi’s clinical development of and regulatory filings for
Zynquista (sotagliflozin) and the potential therapeutic and
commercial potential of Zynquista. In addition, this press release
also contains forward-looking statements relating to Lexicon’s
growth and future operating results, discovery, development and
commercialization 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 the FDA and other regulatory authorities
may not grant regulatory approval of Zynquista 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 Zynquista. As a result,
Zynquista may never be successfully commercialized. Other risks
include Lexicon’s ability to meet its capital requirements,
successfully commercialize XERMELO (telotristat ethyl),
successfully conduct preclinical and clinical development and
obtain necessary regulatory approvals of LX2761, LX9211 and its
other potential drug candidates on its anticipated timelines,
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, 2018, 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.
Sanofi 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
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, 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, 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 ability to benefit from external growth opportunities
and/or obtain regulatory clearances, risks associated with
intellectual property and any related pending or future litigation
and the ultimate outcome of such litigation, trends in exchange
rates and prevailing interest rates, volatile economic conditions,
the impact of cost containment initiatives and subsequent changes
thereto, the average number of shares outstanding as well as those
discussed or identified in the public filings with the SEC and the
AMF made by Sanofi, including those listed under "Risk Factors" and
"Cautionary Statement Regarding Forward-Looking Statements" in
Sanofi's annual report on Form 20-F for the year ended December 31,
2018. Other than as required by applicable law, Sanofi does not
undertake any obligation to update or revise any forward-looking
information or statements.
Lexicon Investor Relations
Contact:
Kimberly Lee, D.O.Head of Investor Relations and
Corporate Strategy(281) 863-3383klee@lexpharma.com
Lexicon Media Relations
Contact:
Chas SchultzExecutive Director, Corporate
Communications and Patient Advocacy(281)
863-3421cschultz@lexpharma.com
Sanofi Investor Relations
Contact:
George Grofik+33 (0)1 53 77 45
45ir@sanofi.com
Sanofi Media Relations
Contact:
Nicolas Kressmann(732)
532-5318Nicolas.kressmann@sanofi.com
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