Lexicon Pharmaceuticals Announces Termination of Alliance and Settlement With Sanofi
September 10 2019 - 4:01PM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced the
termination of its alliance with Sanofi for the development and
commercialization of ZynquistaTM (sotagliflozin) and the settlement
of its related disputes with Sanofi, each effective September 9,
2019. In connection with the termination, Lexicon will regain all
rights to Zynquista and assume full responsibility for the
worldwide development and commercialization of Zynquista in both
type 1 and type 2 diabetes. Under the terms of the settlement,
Sanofi will pay Lexicon $260 million, of which $208 million is
payable upfront and the remainder is payable within twelve months,
and coordinate with Lexicon in the transition of responsibility for
ongoing clinical studies and other activities.
“Our four-year alliance with Sanofi has been a
productive one, with Zynquista receiving marketing approval in
Europe in type 1 diabetes and advancing into late-stage studies in
type 2 diabetes,” said Lonnel Coats, president and chief executive
officer of Lexicon. “Regaining worldwide rights allows us to
advance our efforts to realize the full value of the Zynquista
program as we prepare for regulatory filings in the U.S. and in
Europe in type 2 diabetes, with data coming over the next few
months from the remainder of the core Phase 3 studies and over the
longer term from two outcomes studies with potential for
demonstrating cardiovascular and renal benefits. We believe that
this potential, along with a European approval in type 1 diabetes,
offer an attractive opportunity for potential collaborators as we
work to maximize the global potential for Zynquista and to achieve
greater operational flexibility.”
Conference Call and Webcast
Information
Lexicon management will hold a live conference
call and webcast today at 5:00 pm EDT / 4:00 pm CDT to discuss
today’s announcement. The dial-in number for the conference call is
888-645-5785 (U.S./Canada) or 970-300-1531 (international). The
conference ID for all callers is 7376526. The live webcast and
replay may be accessed by visiting Lexicon’s website at
www.lexpharma.com/investors. An archived version of the webcast
will be available on the website for 14 days.
About Zynquista
(sotagliflozin)
Discovered using Lexicon’s unique approach to
gene science, Zynquista is an oral dual inhibitor of two proteins
responsible for glucose regulation known as sodium-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.
Zynquista is approved in the European Union (EU) for use as an
adjunct to insulin therapy to improve blood sugar (glycemic)
control in adults with type 1 diabetes with a body mass index ≥ 27
kg/m2, who could not achieve adequate glycemic control despite
optimal insulin therapy. Outside of such approval, Zynquista is
investigational and has not been approved by any other regulatory
authority for type 1 or type 2 diabetes.
About Lexicon
Pharmaceuticals
Lexicon is a fully integrated biopharmaceutical
company with a mission of pioneering medicines that transform
patients’ lives. Through its Genome5000™ program, Lexicon
scientists studied the role and function of nearly 5,000 genes and
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, Lexicon has a pipeline of promising drug candidates in
clinical and preclinical development in diabetes and metabolism,
oncology 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 long-term
outlook on its business, the commercialization of XERMELO
(telotristat ethyl) and Zynquista (sotagliflozin), and the clinical
development of, the regulatory filings for, and the potential
therapeutic and commercial potential of telotristat ethyl,
sotagliflozin, LX2761 and LX9211. 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 Lexicon’s ability to meet its capital requirements,
successfully commercialize XERMELO, successfully conduct
preclinical and clinical development and obtain necessary
regulatory approvals of telotristat ethyl, sotagliflozin, 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.
For Investor Inquiries:
Kimberly Lee, D.O.Head of Investor Relations and
Corporate StrategyLexicon Pharmaceuticals(281)
863-3383klee@lexpharma.com
For Media Inquiries:
Chas SchultzExecutive Director, Corporate
Communications and Patient AdvocacyLexicon Pharmaceuticals(281)
863-3421cschultz@lexpharma.com
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