ZynquistaTM now approved in the
European Union for treatment of adults with type 1 diabetes
PARIS and THE WOODLANDS, TX - April 26, 2019 - The European
Commission has granted marketing authorization for Zynquista(TM)
(sotagliflozin)*, developed by Sanofi and Lexicon. Zynquista is now
approved in the European Union, at once-daily doses of 200 mg and
400 mg, for use as an adjunct to insulin therapy to improve blood
sugar (glycemic) control in adults with type 1 diabetes (T1D)
mellitus and a body mass index >= 27 kg/m2, who could not
achieve adequate glycemic control despite optimal insulin therapy.
"Millions of people across Europe who live with type 1 diabetes
struggle to control their blood sugar, even with optimal insulin
therapy," commented Thomas Danne, Professor of Pediatrics,
Children's Hospital 'Auf der Bult,' Hannover, Germany. "For the
many people living with type 1 diabetes who are overweight or
obese, Zynquista will offer a new treatment option physicians can
now consider in combination with insulin therapy for appropriate
patients." Zynquista is an oral dual inhibitor of two proteins
responsible for glucose regulation known as sodium-dependent
glucose co-transporter types 1 and 2 (SGLT1 and SGLT2).1 SGLT1 is
responsible for glucose absorption in the gastrointestinal tract,2
and SGLT2 is responsible for glucose reabsorption by the kidney.3
"Zynquista's dual mechanism of action provides important treatment
benefits for adults with type 1 diabetes, including reducing blood
sugar reabsorption in the kidneys through SGLT2 inhibition and
delaying dietary sugar absorption through local SGLT1 inhibition in
the intestinal tract," added John Reed, M.D., Ph.D., Global Head of
Research & Development, Sanofi. The marketing authorization is
based on evidence including data from the inTandem clinical trial
program, which included three Phase 3 clinical trials assessing the
safety and efficacy of sotagliflozin, involving approximately 3,000
adults with inadequately controlled T1D.4-7 "We are proud to have
developed Zynquista in combination with insulin through the largest
Phase 3 clinical trial program to date in adults with type 1
diabetes, and now to have it approved in the European Union," said
Pablo Lapuerta, M.D., Executive Vice President and Chief Medical
Officer, Lexicon. "We thank the European Commission for recognizing
the clinical benefits of Zynquista for adults with type 1 diabetes
and the families and physicians who participated in the clinical
trials." These three trials demonstrated that treatment with
sotagliflozin, when given to adults with inadequately controlled
T1D as an oral adjunct to insulin, resulted in consistent and
significant reductions from baseline at 24 weeks in average blood
sugar (HbA1c), body weight, systolic blood pressure, a significant
improvement of time in target blood sugar range and improved
patient-reported outcomes, versus insulin alone, at both 200-mg and
400-mg doses.4-7 This was achieved without the usual increase in
severe hypoglycemia that comes with intensification of insulin and
with less events of severe hypoglycemia in the 400-mg dose at 52
weeks. Consistent with selective SGLT2 inhibitors, clinical trials
with sotagliflozin showed an increased risk of genital mycotic
infections and diabetic ketoacidosis (DKA), which is acknowledged
to affect people with T1D more frequently than those with type 2
diabetes (T2D). Several leaders in the diabetes scientific
community consider the risk of DKA associated with SGLT inhibitors
manageable with appropriate patient selection, education and ketone
monitoring in place.8-11 The risk of DKA will be addressed by
careful selection of patients for treatment with sotagliflozin and
through a risk-management plan and a mitigation strategy, including
patient, healthcare professional and care giver educational
activities, that will support its safe use. Zynquista is also
currently being evaluated in a program of 11 clinical trials in
adults with T2D, including two trials in people living with T2D and
renal impairment, and two large cardiovascular outcomes trials.
*Zynquista(TM) (sotagliflozin) is not currently approved for use in
any other markets, where it is considered an investigational
product. References Lapuerta P, et al. Diabetes and Vascular
Disease Research. 2015;12(2):101-10, DOI: 10.1177/1479164114563304.
Hummel CS et al. Am J Physiol Cell Physiol 2011;300(1):C14-C21,
DOI: 10.1152/ajpcell.00388.2010. Wright EM et al. Physiol Rev
2011;91:733-794. Buse JB et al, Diabetes Care 2018 Jun; dc180343.
https://doi.org/10.2337/dc18-0343. Danne T et al, Diabetes Care
2018 Jun; dc180342. https://doi.org/10.2337/dc18-0342. Garg SK et
al, N Engl J Med 2017; 377:2337-2348, DOI: 10.1056/NEJMoa1708337.
Danne T et al. "inTandem1 and inTandem2: increased time in range
with sotagliflozin as adjunct therapy to insulin in adults with
type 1 diabetes by 24-week continuous glucose monitoring", Abstract
#610, presented at European Association for the Study of Diabetes
54th Annual Meeting, October 1-5, 2018, Berlin, Germany. Available
via
https://www.easd.org/virtualmeeting/home.html#!resources/intandem1-and-intandem2-increased-time-in-range-with-sotagliflozin-as-adjunct-therapy-to-insulin-in-adults-with-type-1-diabetes-by-24-week-continuous-glucose-monitoring
[Accessed April 2019]. Peters AL et al. Diabetes Care 2015
Jun; dc150843.https://doi.org/10.2337/dc15-0843 Rosenstock J,
Ferrannini E. Diabetes Care 2015
Sep; 38(9): 1638-1642.https://doi.org/10.2337/dc15-1380
Garber AJ et al. Endocrine Practice: January 2019, Vol. 25, No. 1,
pp. 69-100.https://doi.org/10.4158/CS-2018-0535 Danne T et al.
Diabetes Care 2019
Feb; dc182316.https://doi.org/10.2337/dc18-2316 About
Lexicon PharmaceuticalsLexicon (NASDAQ: LXRX) 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(TM) 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 |
Sanofi Media Relations Contact Nicolas Kressmann Tel: +1
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ir@sanofi.com |
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281-863-3421 cschultz@lexpharma.com |
Lexicon Investor
Relations Contact Kimberly Lee, D.O. Tel: 281-863-3383
klee@lexpharma.com |
Sanofi Forward-Looking StatementsThis 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 regarding
the marketing and other potential of the product, or regarding
potential future revenues from the product. 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, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the absence of guarantee that
the product will be commercially successful, the uncertainties
inherent in research and development, including future clinical
data and analysis of existing clinical data relating to the
product, including post marketing, unexpected safety, quality or
manufacturing issues, competition in general, risks associated with
intellectual property and any related future litigation and the
ultimate outcome of such litigation, and volatile economic
conditions, as well as those risks 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 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. |