Pharma BD Deal Intelligence

Sanofi SA / Lexicon Pharmaceuticals Inc.

2015 · Licensing/Option · $1.7B · Terminated

A bust: Sanofi's $1.7B licensing deal for sotagliflozin fell apart when it terminated the agreement in 2019 after regulatory setbacks, leaving Lexicon to independently win approval for the drug (as Inpefa) for heart failure in 2023.

WRONG BY 31 POINTS
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The coverage arc

Nov 06, 2015 PR Newswire Bullish

Under the terms of the agreement, Lexicon will receive an upfront payment of $300 million and is eligible to receive development, regulatory and sales…

Jul 29, 2019 Genetic Engineering & Biotechnology News Neutral

Lexicon fires back after Sanofi ends up-to-$1.7B diabetes collaboration. Total deal potential was $1.7 billion including $300 million upfront and $1.4 billion…

Aug 04, 2025 FDANews Neutral

Sanofi partners with Lexicon Pharmaceuticals to develop sotagliflozin, with Lexicon receiving a $300 million upfront payment and eligibility for up to…

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Sanofi licensed sotagliflozin, a dual SGLT1/SGLT2 inhibitor, from Lexicon for global development and commercialization in diabetes and cardiovascular disease. Lexicon received $300M upfront, $100M equity, with up to $2.42B in milestones. The deal was terminated by Sanofi in 2019 following regulatory setbacks. Lexicon later independently obtained approval for Inpefa (sotagliflozin) for heart failure in 2023.

Key facts

Disease & market context

Heart Failure (SGLT Inhibition)

550K US cases/yr · $11.0B Global Heart Failure Market (2017) · 33% CV Death/HF Reduction (SOLOIST-WHF)

Disease Overview

Sotagliflozin inhibits both SGLT1 (gut) and SGLT2 (kidney), providing complementary cardiorenal protection. SOLOIST-WHF demonstrated 33% reduction in CV death and HF events.

Deal Termination & Revival

Sotagliflozin (Inpefa, Lexicon) competes with selective SGLT2 inhibitors dapagliflozin (Farxiga, AstraZeneca; DAPA-HF, DELIVER) and empagliflozin (Jardiance, Lilly/Boehringer Ingelheim; EMPEROR-Reduced, EMPEROR-Preserved) which both hold broad HFrEF and HFpEF labels. Adjacent HF backbone includes sacubitril/valsartan (Entresto, Novartis) and finerenone (Kerendia, Bayer).

Heart Failure

550K US cases/yr · $11.0B Global Heart Failure Market (2017) · ~50% 5-Year HF Mortality Rate

Disease Overview

Sotagliflozin's dual SGLT1/SGLT2 inhibition offered broader cardiorenal benefits than SGLT2-only inhibitors, with additional gut-level glucose absorption reduction.

Post-Deal Reality

Inpefa (sotagliflozin, Lexicon) competes in HF with SGLT2 inhibitors dapagliflozin (Farxiga, AstraZeneca) and empagliflozin (Jardiance, Lilly/Boehringer Ingelheim), both with broad HFrEF/HFpEF labels. Background standards include sacubitril/valsartan (Entresto, Novartis), beta blockers, MRAs (spironolactone, Kerendia/finerenone), and loop diuretics.

Type 1 Diabetes

64K US cases/yr · $8.0B Global T1D Market (2017) · ~33% T1D Patients at HbA1c Goal

Disease Overview

Sotagliflozin was investigated as an oral adjunct to insulin for T1D. The dual SGLT1/2 mechanism delays gut glucose absorption while promoting renal excretion. DKA risk proved a significant hurdle.

Regulatory Outcome

EU CHMP rejected sotagliflozin for T1D in 2019 due to DKA concerns, triggering Sanofi's exit. The T1D indication was abandoned.

Deal timeline

Related deals — scored

DealYearValueOutcome
Sanofi SA / Lexicon Pharmaceuticals Inc. (this deal)2015$1.7B44
Sanofi SA / Regeneron Pharmaceuticals, Inc.2007$1.0B97
Sanofi SA / Synthelabo S.A.1998$11.0B84
Sanofi SA / Genzyme Corporation2011$20.1B84
Sanofi SA / Amunix Pharmaceuticals Inc.2021$1.2B76
Sanofi SA / Genzyme Corporation2010$18.5B75
Sanofi SA / Translate Bio Inc.2018$805M73

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