Lexicon Grants Viatris Exclusive Rights for Sotagliflozin Outside U.S. and Europe

Lexicon Pharmaceuticals, Inc., based in The Woodlands, Texas, has announced a significant licensing agreement with Viatris Inc. Under this agreement, Viatris has obtained exclusive rights to commercialize Lexicon's sotagliflozin outside the United States and Europe across all indications. Meanwhile, Lexicon retains the commercialization rights within the U.S. and European markets. The deal includes an upfront payment of $25 million to Lexicon, with the potential for additional milestone payments and tiered royalties on annual net sales.

Sotagliflozin, approved by the U.S. Food and Drug Administration in May 2023, is aimed at reducing the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. This agreement allows Lexicon to leverage Viatris's extensive global commercial capabilities to reach more patients in need of sotagliflozin.

Dr. Mike Exton, CEO and director of Lexicon, expressed satisfaction with the partnership, citing Viatris’s strong expertise in cardiometabolic diseases and its successful track record in new market launches. Dr. Exton emphasized that this partnership is aligned with Lexicon’s "Lead to Succeed" strategy, which aims to collaborate with high-quality companies to support the global commercialization of their medicines. He also indicated that Lexicon plans to explore additional strategic partnerships to enhance their developmental and commercial capacities, thereby expanding their pipeline and access to their medicines worldwide.

Corinne Le Goff, Viatris's chief commercial officer, highlighted the benefits of this licensing agreement, noting that it would add a valuable asset to Viatris’s portfolio of innovative cardiovascular treatments. Le Goff expressed confidence in Viatris’s ability to maximize the potential of sotagliflozin through their robust foundation in cardiovascular diseases and unique infrastructure, ultimately aiming to expand patient access to this important medication.

The terms of the agreement specify that Viatris will handle all regulatory and commercialization activities for sotagliflozin in the licensed territories. Lexicon will continue to supply clinical and commercial quantities of sotagliflozin to Viatris at an agreed transfer price.

Lexicon Pharmaceuticals is dedicated to pioneering medical treatments that significantly improve patients' lives. Through their Genome5000™ program, Lexicon's scientists have analyzed the functions of nearly 5,000 genes, identifying over 100 protein targets with significant therapeutic potential. Currently, Lexicon is launching INPEFA® (sotagliflozin) in the United States and has several other promising drug candidates in various stages of development for conditions such as neuropathic pain, diabetes, and metabolic disorders.

Viatris Inc., a global healthcare company, aims to bridge the gap between generic and branded medicines. They provide high-quality medicines to approximately one billion patients worldwide annually, addressing a broad spectrum of health needs. With an extensive portfolio of medicines and a global supply chain, Viatris is well-positioned to address persistent health challenges globally.

Sotagliflozin, discovered through Lexicon’s gene science approach, is an oral inhibitor targeting two proteins crucial for glucose regulation, SGLT2 and SGLT1. It has been studied in around 20,000 patients across various conditions, including heart failure, diabetes, and chronic kidney disease. The medication is designed to reduce risks associated with cardiovascular issues and has shown promise in clinical trials involving diverse patient populations.

The collaboration between Lexicon Pharmaceuticals and Viatris Inc. is expected to significantly enhance the global availability of sotagliflozin, thereby benefiting a larger number of patients in need of this innovative treatment.