{"id":60630,"date":"2024-10-17T00:00:35","date_gmt":"2024-10-17T00:00:35","guid":{"rendered":"https:\/\/english.saigonbiz.com.vn\/2024\/10\/17\/lexicon-announces-exclusive-licensing-agreement-with-viatris-for-sotagliflozin-in-all-markets-outside-of-the-u-s-and-europe\/"},"modified":"2024-10-17T00:00:35","modified_gmt":"2024-10-17T00:00:35","slug":"lexicon-announces-exclusive-licensing-agreement-with-viatris-for-sotagliflozin-in-all-markets-outside-of-the-u-s-and-europe","status":"publish","type":"post","link":"https:\/\/english.saigonbiz.com\/vn\/lexicon-announces-exclusive-licensing-agreement-with-viatris-for-sotagliflozin-in-all-markets-outside-of-the-u-s-and-europe\/","title":{"rendered":"Lexicon Announces Exclusive Licensing Agreement With Viatris for Sotagliflozin in All Markets Outside of the U.S. and Europe"},"content":{"rendered":"<div>\n<p><em>-Lexicon to receive an upfront payment of $25 million and the potential for contingent regulatory and commercial milestone payments<\/em><\/p>\n<p align=\"justify\">THE WOODLANDS, Texas, Oct.  16, 2024  (GLOBE NEWSWIRE) &#8212; Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Viatris Inc. (Nasdaq: VTRS) has obtained an exclusive license from Lexicon to commercialize sotagliflozin outside of the United States and Europe in all indications. Lexicon retains sole commercialization rights for sotagliflozin in all indications in the United States and Europe.<\/p>\n<p align=\"justify\">Sotagliflozin was approved by the U.S. Food and Drug Administration in May 2023 to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.<\/p>\n<p align=\"justify\">\u201cWe are pleased to be working with Viatris, a company with strong cardiometabolic expertise, global commercial capabilities and a successful track record of launching medicines in new territories. We are confident that this agreement will expand the reach of sotagliflozin to more patients in need,\u201d said Dr. Mike Exton, Ph.D., chief executive officer and director of Lexicon. \u201cPartnering with high quality companies to support commercialization of our medicines globally is a critical pillar of our <em>Lead to Succeed<\/em> strategy at Lexicon. We plan to continue to evaluate strategic partnerships for additional assets, territories and indications to augment Lexicon\u2019s development and commercial capabilities, advance our pipeline and expand access of our medicines to more patients around the world.\u201d<\/p>\n<p align=\"justify\">Viatris chief commercial officer Corinne Le Goff said: \u201cThis licensing agreement with Lexicon adds another asset to our expanding innovative portfolio in cardiovascular diseases which gives us the opportunity to further drive accelerated and durable revenue growth in the future. We believe we will be able to leverage our strong foundation in cardiovascular diseases and our unique infrastructure to execute on the potential of sotagliflozin. We look forward to working with Lexicon to make a real difference and expand access for patients.\u201d<\/p>\n<p align=\"justify\">Under the terms of the agreement, Viatris has acquired rights to sotagliflozin in all global markets outside of the U.S. and Europe in exchange for an upfront payment to Lexicon of $25 million, and the potential for contingent regulatory and sales milestone payments and tiered royalties ranging from low-double-digit to upper-teens on annual net sales.\u00a0\u00a0 Viatris will be responsible for all regulatory and commercialization activities for sotagliflozin in the licensed territories. Lexicon will be responsible for providing clinical and commercial supply of sotagliflozin to Viatris at an agreed upon transfer price.<\/p>\n<p align=\"justify\"><strong>About Lexicon Pharmaceuticals<\/strong>\u00a0<br \/>Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients\u2019 lives. Through its Genome5000&#x2122; 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. Lexicon is commercially launching one of these medicines, INPEFA<sup>\u00ae<\/sup> (sotagliflozin) in the United States, and has a pipeline of other promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, diabetes and metabolism and other indications.\u00a0 For additional information, please visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=8bXNW-oShY-zbm836bxSy827H5fF9qDyH_nooSJqJjiEkRgrlY2MzhtUpdOXRE9Mcpy7t9GN2nN_WMwx53eUFQRKFd14gc2uRzt1x9xDtVQ=\" rel=\"nofollow noopener\" target=\"_blank\" title=\"www.lexpharma.com\">www.lexpharma.com<\/a>.<\/p>\n<p align=\"justify\"><strong>About Viatris<\/strong><br \/>Viatris Inc. (Nasdaq: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, Viatris provides access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life\u2019s moments, from birth to the end of life, acute conditions to chronic diseases. With its exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world\u2019s most enduring health challenges, access takes on deep meaning at Viatris. Viatris is headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India.\u00a0\u00a0 Learn more at viatris.com and investor.viatris.com, and connect with Viatris on LinkedIn, Instagram, YouTube and X (formerly Twitter).<\/p>\n<p align=\"justify\"><strong>About Sotagliflozin<br \/><\/strong>Discovered using Lexicon\u2019s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients.<\/p>\n<p><strong>INDICATION<\/strong><\/p>\n<p>INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:\u202f\u00a0<\/p>\n<ul type=\"disc\">\n<li>heart failure or\u202f\u00a0<\/li>\n<li>type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors\u202f\u00a0<\/li>\n<\/ul>\n<p><strong>IMPORTANT SAFETY INFORMATION<\/strong>\u202f\u00a0<\/p>\n<p><strong>Dosing:<\/strong>\u202fAssess renal function and volume status and, if necessary, correct volume depletion prior to initiation of INPEFA.\u202f INPEFA dosing for patients with decompensated heart failure may begin when patients are hemodynamically stable, including when hospitalized or immediately upon discharge.\u202f\u00a0<\/p>\n<p><strong>Contraindications:<\/strong>\u202fINPEFA is contraindicated in patients with hypersensitivity to INPEFA or any of its components.\u202f\u00a0<\/p>\n<p><strong>Ketoacidosis:<\/strong>\u202fINPEFA increases the risk of ketoacidosis in patients with type 1 diabetes mellitus (T1DM).\u202f Type 2 diabetes Mellitus (T2DM) and pancreatic disorders are also risk factors.\u202f The risk of ketoacidosis may be greater with higher doses.\u202f There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes using sodium glucose transporter 2 (SGLT2) inhibitors.\u202f Before initiating INPEFA, assess risk factors for ketoacidosis. Consider ketone monitoring in patients with T1DM and consider ketone monitoring in others at risk for ketoacidosis and educate patients on the signs\/symptoms of ketoacidosis.\u202f Patients receiving INPEFA may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.\u202f INPEFA is not indicated for glycemic control.\u202f\u00a0<\/p>\n<p>Assess patients who present with signs and symptoms of metabolic acidosis or ketoacidosis, regardless of blood glucose level.\u202f If suspected, discontinue INPEFA, evaluate, and treat promptly.\u202f Monitor patients for resolution of ketoacidosis before restarting INPEFA.\u202f\u00a0<\/p>\n<p><strong>Volume Depletion:<\/strong>\u202fINPEFA can cause intravascular volume depletion which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine.\u202f There have been post-marketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors.\u202f Patients with impaired renal function (eGFR &lt; 60 mL\/min\/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension.\u202f Before initiating INPEFA in patients with one or more of these characteristics, assess volume status and renal function, and monitor for signs and symptoms of hypotension during therapy.\u202f\u00a0<\/p>\n<p><strong>Urosepsis and Pyelonephritis:<\/strong>\u202fTreatment with SGLT2 inhibitors, including INPEFA, increases the risk for urinary tract infections.\u202f Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been reported. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly.\u202f\u00a0<\/p>\n<p><strong>Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues:<\/strong>\u202fInsulin and insulin secretagogues are known to cause hypoglycemia.\u202f INPEFA may increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue.\u202f Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used with INPEFA.<\/p>\n<p><strong>Necrotizing Fasciitis of the Perineum (Fournier\u2019s Gangrene):<\/strong>\u202fReports of Fournier\u2019s Gangrene, a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in post-marketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors.\u202f Assess patients who present with pain, tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement.\u202f Discontinue INPEFA, closely monitor patient signs and symptoms, and provide appropriate alternative therapy for heart failure.\u202f\u00a0<\/p>\n<p><strong>Genital Mycotic Infections:<\/strong>\u202fINPEFA increases the risk of genital mycotic infections.\u202f Monitor and treat as appropriate.\u202f\u00a0<\/p>\n<p><strong>Urinary Glucose Test and 1,5-anhydroglucitol (1,5-AG) Assay:<\/strong>\u202fthese are not reliable for patients taking SGLT2 inhibitors.\u202f Use alternative testing methods to monitor glucose levels.<strong>\u202f<\/strong>\u202f\u00a0<\/p>\n<p><strong>Common Adverse Reactions:<\/strong>\u202fthe most commonly reported adverse reactions (incidence \u2265 5%) were urinary tract infection, volume depletion, diarrhea, and hypoglycemia.\u202f\u00a0<\/p>\n<p><strong>Drug Interactions:<\/strong>\u202f\u00a0<\/p>\n<ul type=\"disc\">\n<li><strong>Digoxin:<\/strong>\u202fMonitor patients appropriately as there is an increase in the exposure of digoxin when coadministered with INPEFA 400\u202fmg.\u00a0<\/li>\n<li><strong>Uridine 5&#8242;-diphospho-glucuronosyltransferase (UGT) Inducer:<\/strong>\u202fThe coadministration of rifampicin, an inducer of UGTs, with sotagliflozin resulted in a decrease in the exposure of sotagliflozin.\u202f\u202f\u00a0<\/li>\n<li><strong>Lithium:<\/strong>\u202fConcomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations.\u202f Monitor serum lithium concentration more frequently during INPEFA initiation and with dosage changes.\u202f<\/li>\n<\/ul>\n<p><strong>Use in Specific Populations:<\/strong>\u202f\u00a0<\/p>\n<ul type=\"disc\">\n<li><strong>Pregnancy and Lactation:<\/strong>\u202fINPEFA is not recommended during the second and third trimesters of pregnancy, nor while breastfeeding.\u202f\u00a0<\/li>\n<li><strong>Geriatric Use:<\/strong>\u202fNo INPEFA dosage change is recommended based on age.\u202f No overall differences in efficacy were detected between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.\u202f Elderly patients may be at increased risk for volume depletion adverse reactions, including hypotension.<\/li>\n<li><strong>Renal Impairment:<\/strong>\u202fINPEFA was evaluated in patients with chronic kidney disease (eGFR 25 to 60\u202fmL\/min\/1.73 m<sup>2<\/sup>) and in patients with heart failure with eGFR &lt;\u202f60\u202fmL\/min\/1.73 m<sup>2<\/sup>.\u202f The safety profile of INPEFA across eGFR subgroups in these studies was consistent with the known safety profile.\u202f There was an increase in volume-related adverse events (e.g., hypotension, dizziness) in patients with eGFR &lt;\u202f30\u202fmL\/min\/1.73m<sup>2\u202f<\/sup>relative to the overall safety population.\u202f Efficacy and safety studies with INPEFA did not enroll patients with an eGFR less than 25 mL\/min\/1.73 m<sup>2<\/sup>\u202for on dialysis.\u202f After starting therapy in the studies, patients were discontinued if eGFR fell below 15 mL\/min\/1.73 m<sup>2<\/sup>\u202for were initiated on chronic dialysis.<\/li>\n<li><strong>Hepatic Impairment:<\/strong>\u202fINPEFA is not recommended in patients with moderate or severe hepatic impairment.<\/li>\n<\/ul>\n<p><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=oXs0MtOk6wwC6jHPEux4VijKAfXwrDIHW5hewtEFkpw031kPE1EiS8GM3hu6vnLR7E3NW4cbY8PfQ01O0grekXm_L6Vb3Le9LZmTCz3h0dclgl6GaNWAXsGfH3TsTm3Btc4ayRKmRLpOtsbDnNTdsw==\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><u>Click here for full Prescribing Information.<\/u><\/a><\/p>\n<p><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=5nNvfZf6hjMRQFX1BChSmuZOulYtbfRe_d_tmRYoLJ5kBBi4LbqqsEsjMktMqCc99DboDa1wVOVpy78iYlke85leuBQALSsYAjyt4nLBhOypUdYnTAV5TXFPnhUQBnaj54WTN5h3Ey82G9kzclQ5CQ==\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><u>https:\/\/www.lexpharma.com\/inpefa-US-PI.pdf<\/u><\/a><\/p>\n<p align=\"justify\"><strong>Safe Harbor Statement<\/strong><\/p>\n<p align=\"justify\"><em>This press release contains \u201cforward-looking statements,\u201d including statements relating to Lexicon\u2019s financial position and long-term outlook on its business, growth and future operating results, discovery and development 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\u2019s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon\u2019s ability to meet its capital requirements, successfully commercialize INPEFA in heart failure on the timeline and\/or at the prices currently contemplated or at all, conduct preclinical and clinical development and obtain necessary regulatory approvals of <\/em><em><u> sotagliflozin<\/u><\/em><em> (in other indications), LX9211, LX9851 and its other 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\u2019s 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 \u201cRisk Factors\u201d in Lexicon\u2019s annual report on Form 10-K for the year ended December 31, 2023 and other subsequent disclosure documents 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.<\/em><\/p>\n<p align=\"justify\"><strong>For Media and Investor Inquiries<\/strong>:<\/p>\n<p align=\"justify\">Lisa DeFrancesco<br \/>Lexicon Pharmaceuticals, Inc.<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=4Se9-pBi_wqkqLdj9sVheBIgIWZs-f3tvSJHKUoS8PzCzxJwFRdrqWlJWuhIAByJKUn3rDNL345UN99kCG5E7NK6oLY3oH7wcwn_YWozeVA=\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><u>lexinvest@lexpharma.com<\/u><\/a><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/ml.globenewswire.com\/media\/MzY2YmE5ODUtODQwNS00MjY4LWJmN2UtMDA3ZGE1MWEyYTkyLTEwMTU1NDA=\/tiny\/Lexicon-Pharmaceuticals-Inc-.png\" referrerpolicy=\"no-referrer-when-downgrade\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>-Lexicon to receive an upfront payment of $25 million and the potential for contingent regulatory and commercial milestone payments THE WOODLANDS, Texas, Oct. 16, 2024 (GLOBE NEWSWIRE) &#8212; Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Viatris Inc. (Nasdaq: VTRS) has obtained an exclusive license from Lexicon to commercialize sotagliflozin outside of the United States [&#8230;]\n","protected":false},"author":1,"featured_media":60631,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-60630","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pr-newswire"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.6 (Yoast SEO v21.6) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Lexicon Announces Exclusive Licensing Agreement With Viatris for Sotagliflozin in All Markets Outside of the U.S. and Europe - Biz and Live in Saigon<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/english.saigonbiz.com\/vn\/lexicon-announces-exclusive-licensing-agreement-with-viatris-for-sotagliflozin-in-all-markets-outside-of-the-u-s-and-europe\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Lexicon Announces Exclusive Licensing Agreement With Viatris for Sotagliflozin in All Markets Outside of the U.S. and Europe\" \/>\n<meta property=\"og:description\" content=\"-Lexicon to receive an upfront payment of $25 million and the potential for contingent regulatory and commercial milestone payments THE WOODLANDS, Tex\" \/>\n<meta property=\"og:url\" content=\"https:\/\/english.saigonbiz.com\/vn\/lexicon-announces-exclusive-licensing-agreement-with-viatris-for-sotagliflozin-in-all-markets-outside-of-the-u-s-and-europe\/\" \/>\n<meta property=\"og:site_name\" content=\"Biz and Live in Saigon\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/SaigonbizGroup\" \/>\n<meta property=\"article:published_time\" content=\"2024-10-17T00:00:35+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/english.saigonbiz.com\/vn\/wp-content\/uploads\/2024\/10\/Lexicon-Pharmaceuticals-Inc-.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1\" \/>\n\t<meta property=\"og:image:height\" content=\"1\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"10 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/lexicon-announces-exclusive-licensing-agreement-with-viatris-for-sotagliflozin-in-all-markets-outside-of-the-u-s-and-europe\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/lexicon-announces-exclusive-licensing-agreement-with-viatris-for-sotagliflozin-in-all-markets-outside-of-the-u-s-and-europe\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/#\/schema\/person\/267b348e6cf32a66aab33637c2d399a6\"},\"headline\":\"Lexicon Announces Exclusive Licensing Agreement With Viatris for Sotagliflozin in All Markets Outside of the U.S. and Europe\",\"datePublished\":\"2024-10-17T00:00:35+00:00\",\"dateModified\":\"2024-10-17T00:00:35+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/lexicon-announces-exclusive-licensing-agreement-with-viatris-for-sotagliflozin-in-all-markets-outside-of-the-u-s-and-europe\/\"},\"wordCount\":1947,\"publisher\":{\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/#organization\"},\"articleSection\":[\"Pr Newswire\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/lexicon-announces-exclusive-licensing-agreement-with-viatris-for-sotagliflozin-in-all-markets-outside-of-the-u-s-and-europe\/\",\"url\":\"https:\/\/english.saigonbiz.com\/vn\/lexicon-announces-exclusive-licensing-agreement-with-viatris-for-sotagliflozin-in-all-markets-outside-of-the-u-s-and-europe\/\",\"name\":\"Lexicon Announces Exclusive Licensing Agreement With Viatris for Sotagliflozin in All Markets Outside of the U.S. and Europe - 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