{"id":2997,"date":"2023-07-13T12:12:42","date_gmt":"2023-07-13T12:12:42","guid":{"rendered":"https:\/\/serb1.wpengine.com\/?post_type=news&#038;p=2997"},"modified":"2023-07-13T12:12:43","modified_gmt":"2023-07-13T12:12:43","slug":"serb-pharmaceuticals-acquires-vistogard-and-xuriden-from-wellstat-therapeutics","status":"publish","type":"news","link":"https:\/\/serb.com\/nl\/news\/serb-pharmaceuticals-acquires-vistogard-and-xuriden-from-wellstat-therapeutics\/","title":{"rendered":"SERB Pharmaceuticals acquires Vistogard\u00ae and Xuriden\u00ae from Wellstat Therapeutics"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>West Conshohocken, PA, 13 July 2023:<\/strong> SERB Pharmaceuticals, a global specialty pharmaceutical company, announced today that it has acquired two life-saving medicines, Vistogard<sup>\u00ae<\/sup> (<em>uridine triacetate<\/em>) and Xuriden<sup>\u00ae <\/sup>(<em>uridine triacetate<\/em>), from Wellstat Therapeutics. Both medicines are commercially available in the US and currently distributed across Europe on a named patient or compassionate use basis.\u00a0<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Vistogard\u00ae is an emergency treatment for adult and pediatric patients following a fluorouracil (5-FU) or capecitabine overdose regardless of the presence of symptoms, or who exhibit early-onset, severe or life- threatening toxicity affecting the cardiac or central nervous system, and\/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and\/or neutropenia) within 96 hours following the end of 5-FU or capecitabine administration.(i) 5-FU and capecitabine are chemotherapy agents commonly used to treat a wide variety of solid tumors.<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Xuriden\u00ae is a treatment for adult and pediatric patients with hereditary orotic aciduria (HOA) (ii), an ultra-rare, orphan genetic disorder associated megaloblastic anemia as well as failure to thrive, developmental delay, epilepsy, susceptibility to infection, and orotic acid crystals in the urine.(iii)<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Jeremie Urbain, President of SERB Pharmaceuticals, said: \u201cWe\u2019re proud to add these two treatments to our expanding portfolio of medicines for complex, life-threatening conditions. Acquiring these medicines is in line with our strategy to focus on emergency care and rare diseases.\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The products will be sold in the US by BTG Pharmaceuticals, SERB\u2019s US entity. The products will transition seamlessly from Wellstat to BTG Pharmaceuticals and will continue to be available from the same distributors via the same ordering processes:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>To order Vistogard<sup>\u00ae<\/sup>, please call 1-800-914-0071. Vistogard<sup>\u00ae<\/sup> is distributed through Cardinal Health Specialty Pharmaceutical Distribution, available 24 hours\/day, 7 days\/week.<\/li>\n\n\n\n<li>Vistogard\u00ae and Xuriden<sup>\u00ae<\/sup> are available for dispensing through BioMatrix Specialty Pharmacy. To reach BioMatrix Specialty Pharmacy, please call: 844-374-0604.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">BTG Pharmaceuticals, a SERB company, will promote Vistogard<sup>\u00ae<\/sup> and continue promoting Voraxaze<sup>\u00ae<\/sup> through its oncology field force in the US.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The companies did not disclose specific financial terms. Today\u2019s news follows the <a href=\"https:\/\/serb.com\/news\/serb-pharmaceuticals-and-sfj-pharmaceuticals-announce-a-u-s-partnership-for-bentracimab-a-ticagrelor-reversal-agent\/\">announcement in May<\/a> that SERB has acquired the exclusive US rights to bentracimab, which is in development as a\u00a0ticagrelor reversal agent.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">About Fluorouracil (5-FU) and capecitabine toxicity<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">5-FU and capecitabine are both trusted chemotherapies received by thousands of patients, often in combination with other chemotherapy agents or radiation. They have a history of success in treating a range of cancers including breast, colorectal (bowel), gastric (stomach), and pancreatic cancer.<br>According to the National Institute of Health (NIH), about 275,000 patients in the US receive 5-FU every year. Capecitabine, a prodrug that is enzymatically converted to 5-FU within the body, has about 60,000 treatment packages sold per year. Approximately 3% of these patients develop serious toxicities and more than 8,000 toxic reactions and 1,300 deaths every year are attributed to 5-FU and capecitabine. (iv)<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">About HOA<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Hereditary orotic aciduria (HOA) is a very rare inborn error of pyrimidine metabolism caused by mutations reducing the activity of uridine monophosphate synthase (UMPS), which converts orotic acid to UMP. \u00a0Uridine deficiency underlies many of the symptoms of HOA. When untreated, patients with HOA may develop a blood (hematologic) disorder called megaloblastic anemia as well as exhibiting failure to thrive, developmental delay, epilepsy, susceptibility to infection and orotic acid crystals in the urine (crystalluria).(iii)<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">About SERB Pharmaceuticals<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">SERB is a global specialty pharmaceutical company with a growing portfolio of medicines for emergency care and rare diseases. For over 30 years we have made treating these complex and life-threatening conditions possible, supporting clinicians, healthcare systems and governments while offering hope to patients and their families. SERB has the broadest antidote portfolio in the world, including medical countermeasures for chemical, biological, radiological, and nuclear (CBRN) risks. As a fully integrated company, we have the experience and capabilities to acquire, develop, and manufacture our medicines to the highest standards, and make them available worldwide through our secure supply chain. SERB operates in the US as BTG Pharmaceuticals. \u00a0Learn more at <a href=\"https:\/\/SERB.com\">https:\/\/SERB.com<\/a>.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">For further information contact:<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Chris Sampson, Corporate Communications Director<br><a href=\"mailto:chris.sampson@serb.com\">chris.sampson@serb.com<\/a>; Tel: +44 (0)7773 251 178<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">About Vistogard<sup>\u00ae<\/sup><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Indication<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">VISTOGARD<sup>\u00ae<\/sup>&nbsp;is indicated for the emergency treatment of adult and pediatric patients:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or<\/li>\n\n\n\n<li>who exhibit early-onset, severe or life- threatening toxicity affecting the cardiac or central nervous system, and\/or early onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and\/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Limitations of use<\/strong><strong><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>VISTOGARD<sup>\u00ae<\/sup>&nbsp;is not recommended for the non\u2013emergent treatment of adverse reactions associated with fluorouracil or capecitabine because it may diminish the efficacy of these drugs.<\/li>\n\n\n\n<li>The safety and efficacy of VISTOGARD initiated more than 96 hours following the end of fluorouracil or capecitabine administration have not been established.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Important Safety Information<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>In clinical studies, adverse reactions occurring in &gt;2% of patients receiving VISTOGARD<sup>\u00ae<\/sup>&nbsp;included vomiting (10%), nausea (5%), and diarrhea (3%).<\/li>\n\n\n\n<li>One person receiving uridine triacetate experienced grade 3 nausea and vomiting.<\/li>\n\n\n\n<li>VISTOGARD<sup>\u00ae<\/sup>&nbsp;was discontinued for adverse reactions in 2 (1.4%) patients.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">See full <a href=\"https:\/\/www.vistogard.com\/Vistogard\/media\/Main-Media\/Professional\/PDFs\/final-labeling-text-vistogard-2-2018.pdf\">prescribing information<\/a>.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">About Xuriden<sup>\u00ae<\/sup><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Indication<\/strong><strong><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">XURIDEN\u00ae is indicated in adult and pediatric patients for the treatment of hereditary orotic aciduria.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Important Safety Information<\/strong><strong><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Contraindications \u2013 None.<\/li>\n\n\n\n<li>Warning and Precautions \u2013 None.<\/li>\n\n\n\n<li>Adverse reactions \u2013 No adverse reactions were reported with XURIDEN in patients with HOA.<\/li>\n\n\n\n<li>Pregnancy \u2013 There are no available data on XURIDEN use in pregnant women to inform drug-associated risk.<\/li>\n\n\n\n<li>Lactation\u2013 There are no data on the presence of XURIDEN in human milk, the effect on the breast-fed infant or the effect on milk production. The development and health benefits of breastfeeding should be considered along with the mother\u2019s clinical need for XURIDEN and any potential adverse effects on the breastfed infant from XURIDEN or from the underlying maternal condition.<\/li>\n\n\n\n<li>Pediatric \u2013 The safety and effectiveness of XURIDEN have been established in pediatric patients.&nbsp;<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">See full <a href=\"https:\/\/www.xuriden.com\/FPI.pdf\">prescribing information<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>West Conshohocken, PA, 13 July 2023: SERB Pharmaceuticals, a global specialty pharmaceutical company, announced today that it has acquired two life-saving medicines, Vistogard\u00ae (uridine triacetate) and Xuriden\u00ae (uridine triacetate), from Wellstat Therapeutics. Both medicines are commercially available in the US and currently distributed across Europe on a named patient or compassionate use basis.\u00a0 Jeremie Urbain, [&hellip;]<\/p>\n","protected":false},"featured_media":0,"template":"","class_list":["post-2997","news","type-news","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>SERB Pharmaceuticals acquires Vistogard\u00ae and Xuriden\u00ae from Wellstat Therapeutics - SERB Pharmaceuticals<\/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:\/\/serb.com\/news\/serb-pharmaceuticals-acquires-vistogard-and-xuriden-from-wellstat-therapeutics\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"SERB Pharmaceuticals acquires Vistogard\u00ae and Xuriden\u00ae from Wellstat Therapeutics - SERB Pharmaceuticals\" \/>\n<meta property=\"og:description\" content=\"West Conshohocken, PA, 13 July 2023: SERB Pharmaceuticals, a global specialty pharmaceutical company, announced today that it has acquired two life-saving medicines, Vistogard\u00ae (uridine triacetate) and Xuriden\u00ae (uridine triacetate), from Wellstat Therapeutics. Both medicines are commercially available in the US and currently distributed across Europe on a named patient or compassionate use basis.\u00a0 Jeremie Urbain, [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/serb.com\/news\/serb-pharmaceuticals-acquires-vistogard-and-xuriden-from-wellstat-therapeutics\/\" \/>\n<meta property=\"og:site_name\" content=\"SERB Pharmaceuticals\" \/>\n<meta property=\"article:modified_time\" content=\"2023-07-13T12:12:43+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/serb.com\\\/news\\\/serb-pharmaceuticals-acquires-vistogard-and-xuriden-from-wellstat-therapeutics\\\/\",\"url\":\"https:\\\/\\\/serb.com\\\/news\\\/serb-pharmaceuticals-acquires-vistogard-and-xuriden-from-wellstat-therapeutics\\\/\",\"name\":\"SERB Pharmaceuticals acquires Vistogard\u00ae and Xuriden\u00ae from Wellstat Therapeutics - SERB Pharmaceuticals\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/serb.com\\\/#website\"},\"datePublished\":\"2023-07-13T12:12:42+00:00\",\"dateModified\":\"2023-07-13T12:12:43+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/serb.com\\\/news\\\/serb-pharmaceuticals-acquires-vistogard-and-xuriden-from-wellstat-therapeutics\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/serb.com\\\/news\\\/serb-pharmaceuticals-acquires-vistogard-and-xuriden-from-wellstat-therapeutics\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/serb.com\\\/news\\\/serb-pharmaceuticals-acquires-vistogard-and-xuriden-from-wellstat-therapeutics\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/serb.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"SERB Pharmaceuticals acquires Vistogard\u00ae and Xuriden\u00ae from Wellstat Therapeutics\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/serb.com\\\/#website\",\"url\":\"https:\\\/\\\/serb.com\\\/\",\"name\":\"SERB Pharmaceuticals\",\"description\":\"SERB Pharmaceuticals\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/serb.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"SERB Pharmaceuticals acquires Vistogard\u00ae and Xuriden\u00ae from Wellstat Therapeutics - SERB Pharmaceuticals","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/serb.com\/news\/serb-pharmaceuticals-acquires-vistogard-and-xuriden-from-wellstat-therapeutics\/","og_locale":"en_US","og_type":"article","og_title":"SERB Pharmaceuticals acquires Vistogard\u00ae and Xuriden\u00ae from Wellstat Therapeutics - SERB Pharmaceuticals","og_description":"West Conshohocken, PA, 13 July 2023: SERB Pharmaceuticals, a global specialty pharmaceutical company, announced today that it has acquired two life-saving medicines, Vistogard\u00ae (uridine triacetate) and Xuriden\u00ae (uridine triacetate), from Wellstat Therapeutics. Both medicines are commercially available in the US and currently distributed across Europe on a named patient or compassionate use basis.\u00a0 Jeremie Urbain, [&hellip;]","og_url":"https:\/\/serb.com\/news\/serb-pharmaceuticals-acquires-vistogard-and-xuriden-from-wellstat-therapeutics\/","og_site_name":"SERB Pharmaceuticals","article_modified_time":"2023-07-13T12:12:43+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/serb.com\/news\/serb-pharmaceuticals-acquires-vistogard-and-xuriden-from-wellstat-therapeutics\/","url":"https:\/\/serb.com\/news\/serb-pharmaceuticals-acquires-vistogard-and-xuriden-from-wellstat-therapeutics\/","name":"SERB Pharmaceuticals acquires Vistogard\u00ae and Xuriden\u00ae from Wellstat Therapeutics - SERB Pharmaceuticals","isPartOf":{"@id":"https:\/\/serb.com\/#website"},"datePublished":"2023-07-13T12:12:42+00:00","dateModified":"2023-07-13T12:12:43+00:00","breadcrumb":{"@id":"https:\/\/serb.com\/news\/serb-pharmaceuticals-acquires-vistogard-and-xuriden-from-wellstat-therapeutics\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/serb.com\/news\/serb-pharmaceuticals-acquires-vistogard-and-xuriden-from-wellstat-therapeutics\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/serb.com\/news\/serb-pharmaceuticals-acquires-vistogard-and-xuriden-from-wellstat-therapeutics\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/serb.com\/"},{"@type":"ListItem","position":2,"name":"SERB Pharmaceuticals acquires Vistogard\u00ae and Xuriden\u00ae from Wellstat Therapeutics"}]},{"@type":"WebSite","@id":"https:\/\/serb.com\/#website","url":"https:\/\/serb.com\/","name":"SERB Pharmaceuticals","description":"SERB Pharmaceuticals","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/serb.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/serb.com\/nl\/wp-json\/wp\/v2\/news\/2997","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/serb.com\/nl\/wp-json\/wp\/v2\/news"}],"about":[{"href":"https:\/\/serb.com\/nl\/wp-json\/wp\/v2\/types\/news"}],"wp:attachment":[{"href":"https:\/\/serb.com\/nl\/wp-json\/wp\/v2\/media?parent=2997"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}