The Endocrinologic and Metabolic Drugs Advisory Committee of the
U.S. Food and Drug Administration (FDA) today voted eight to eight
on the question of whether the overall benefits of Zynquista™*
(sotagliflozin) outweighed the risks to support approval.
Sotagliflozin is an investigational oral dual SGLT1 and SGLT2
inhibitor under regulatory review as an adjunct to insulin for the
treatment of adults with type 1 diabetes (T1D). While the FDA is
not required to follow the committee’s vote, the agency considers
the committee’s recommendations when making its decision, which is
anticipated by March 22, 2019.
Sotagliflozin, developed by Sanofi and Lexicon,
has the potential to be the first oral antidiabetic drug approved
in the United States together with insulin therapy to improve
glycemic (blood sugar) control in adults with T1D.
“We believe in the overall benefit-risk profile
of sotagliflozin for adults with type 1 diabetes who lack adequate
glycemic control using insulin alone,” said Rachele Berria, M.D.,
PhD, Global Vice President and Head of Diabetes Medical Affairs,
Sanofi. “We will continue to work with the FDA through its review
process to hopefully bring to patients a new treatment that can
help people living with type 1 diabetes control their blood sugar
and address some of the challenges of insulin-only therapy.”
Sotagliflozin is an investigational oral dual
inhibitor of two proteins responsible for glucose regulation known
as sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and
SGLT2). SGLT1 is responsible for glucose absorption in the
gastrointestinal tract, and SGLT2 is responsible for glucose
reabsorption by the kidney. About 1.3 million Americans have T1D
and an estimated 40,000 people will be newly diagnosed each year in
the U.S., according to the American Diabetes Association.
“In clinical trials, when used in combination
with insulin therapy, sotagliflozin significantly improved glycemic
control without increasing hypoglycemia,” said Pablo Lapuerta,
M.D., Executive Vice President and Chief Medical Officer, Lexicon.
“These results could not be achieved with insulin alone. Diabetic
ketoacidosis is an inherent risk of type 1 diabetes and an increase
was seen with sotagliflozin compared to insulin alone. We believe
this can potentially be addressed with proper education and
monitoring.”
The New Drug Application for sotagliflozin
included data from the inTandem clinical trial program, which
included three Phase 3 clinical trials assessing the safety and
efficacy of sotagliflozin in approximately 3,000 adults with
inadequately controlled T1D. The safety and efficacy data have not
yet been fully evaluated by any regulatory authority.
Sanofi also submitted a regulatory application
to the European Medicines Agency (EMA) in 2018. An EMA approval
decision is expected in the first half of 2019.
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.
*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.
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, 2017, 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, to
complete related transactions 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, 2017. 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+1
732-532-5318mr@sanofi.com
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