Wellstat Therapeutics Corp.

West Conshohocken, PA, July 13, 2023 (GLOBE NEWSWIRE) -- SERB Pharmaceuticals, a global specialty pharmaceutical company, announced today that it has acquired two life-saving medicines, Vistogard® (uridine triacetate) and Xuriden® (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. Vistogard® 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. Xuriden® 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] Jeremie Urbain, President of SERB Pharmaceuticals, said: “We’re 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.” The products will be sold in the US by BTG Pharmaceuticals, SERB’s 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: To order Vistogard®, please call 1-800-914-0071. Vistogard® is distributed through Cardinal Health Specialty Pharmaceutical Distribution, available 24 hours/day, 7 days/week. Vistogard® and Xuriden® are available for dispensing through BioMatrix Specialty Pharmacy. To reach BioMatrix Specialty Pharmacy, please call: 844-374-0604. BTG Pharmaceuticals, a SERB company, will promote Vistogard® and continue promoting Voraxaze® through its oncology field force in the US. The companies did not disclose specific financial terms. Today’s news follows the announcement in May that SERB has acquired the exclusive US rights to bentracimab, which is in development as a ticagrelor reversal agent. About Fluorouracil (5-FU) and capecitabine toxicity 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. 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] About HOA 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. Uridine 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 About SERB Pharmaceuticals 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. Learn more at . About Vistogard® Indication VISTOGARD® is indicated for the emergency treatment of adult and pediatric patients: following a fluorouracil 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 fluorouracil or capecitabine administration. Limitations of use VISTOGARD® is not recommended for the non–emergent treatment of adverse reactions associated with fluorouracil or capecitabine because it may diminish the efficacy of these drugs. The safety and efficacy of VISTOGARD initiated more than 96 hours following the end of fluorouracil or capecitabine administration have not been established. Important Safety Information In clinical studies, adverse reactions occurring in >2% of patients receiving VISTOGARD® included vomiting (10%), nausea (5%), and diarrhea (3%). One person receiving uridine triacetate experienced grade 3 nausea and vomiting. VISTOGARD® was discontinued for adverse reactions in 2 (1.4%) patients. See full prescribing information. About Xuriden® Indication XURIDEN® is indicated in adult and pediatric patients for the treatment of hereditary orotic aciduria. Important Safety Information Contraindications – None. Warning and Precautions – None. Adverse reactions – No adverse reactions were reported with XURIDEN in patients with HOA. Pregnancy – There are no available data on XURIDEN use in pregnant women to inform drug-associated risk. Lactation– 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’s clinical need for XURIDEN and any potential adverse effects on the breastfed infant from XURIDEN or from the underlying maternal condition. Pediatric – The safety and effectiveness of XURIDEN have been established in pediatric patients. See full prescribing information. References [i] Wellstat Therapeutics Corporation (2017). Vistogard (uridine triacetate) US Package Insert. [ii] Wellstat Therapeutics Corporation (2019). Xuriden (uridine triacetate) US Package Insert. [iii] Al Absi HS, Sacharow S, Al Zein N, Al Shamsi A, Al Teneiji A. Hereditary orotic aciduria (HOA): A novel uridine-5-monophosphate synthase (UMPS) mutation. Mol Genet Metab Rep. 2021 Jan 9;26:100703. doi: 10.1016/j.ymgmr.2020.100703. PMID: 33489760; PMCID: PMC7807243. [iv] Santos C, Morgan BW, Geller RJ. The successful treatment of 5-fluorouracil (5-FU) overdose in a patient with malignancy and HIV/AIDS with uridine triacetate. Am J Emerg Med. 2017 May;35(5):802.e7-802.e8. doi: 10.1016/j.ajem.2016.11.038. Epub 2016 Nov 15. PMID: 27884585. Christopher W Sampson SERB Pharmaceuticals +44 7773 251 178 chris.sampson@serb.com

Los Angeles, USA, Aug. 31, 2021 (GLOBE NEWSWIRE) -- DelveInsight Estimates a Promising Gout Pipeline Owing to an Expected Entry of Novel Therapeutic Agents Around 40+ key companies are developing therapies for Gout. Selecta Biosciences appears to have the upper leg being the only company with its Gout drug candidate in the most advanced stage (Phase III). DelveInsight’s ‘Gout Pipeline Insights’ report offers comprehensive coverage of the emerging Gout therapeutics landscape in different stages of development from pre-clinical till a late-end stage, along with dormant, inactive, and abandoned drugs agents. The Gout Pipeline report provides a holistic picture of the ongoing clinical trials, partnerships taking place in the domain, recent happenings in space, and growth prospects across the Gout domain. Some of the key highlights from the Gout Pipeline report: Request for Sample to know more about the therapies that are set to grab maximum patient pool @ Gout Emerging Therapies and Forecast Gout is a chronic disease that is caused due to excess accumulation of uric acid in the body, a condition referred to as hyperuricemia. It is a painful and crystal-induced form of arthritis in which crystals of monosodium urate (MSU) precipitate and deposit in joints of lower limbs. Gout is treatable with medications and changes in diet and lifestyle. For more information on emerging drugs, visit Gout Pipeline Analysis Gout Pipeline Drugs Request for Sample to know more @ Gout Pipeline Analysis, Key Companies, and Futuristic Trends Gout Therapeutic Assessment The Gout Pipeline report lays down complete insights into active Gout pipeline therapies segmented by Stage, Product Type, Route of Administration, Molecule Type, Target, and Mechanism of Action. By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets Get in touch with our Business executive for Informative Business Decisions, Licensing Services  and Consulting Solutions Scope of the Report Coverage: GlobalKey Players: Protalix BioTherapeutics, Shanton Pharma, Horizon Therapeutics, JW Pharmaceutical, Jiangsu Hengrui Medicine Co., Nippon Chemiphar, Sinovent, LG Chem, Selecta Biosciences, TWi Biotechnology, Olatec Therapeutics, Hinova pharmaceuticals, Dyve Biosciences, InventisBio, Arrowhead Pharmaceuticals, Wellstat Therapeutics Corporation, Acquist Therapeutics, TaiwanJ Pharmaceuticals, Atom Bioscience Key Gout Pipeline Therapies: PRX-115, SAP-001, HZN-003, URC-102, SHR4640, NC-2700, XNW3009, LC350189, SEL-212, AC-201, Dapansutrile, HP501, DYV700, D-0120, ARO-XDH, WT-2107, ACQT1127, TJC0434, ABP-072, and many others. Reach out @ Gout Pipeline: Novel therapies and Emerging technologies Table of Contents Visit to know more of what’s covered @ Gout Emerging Therapies, Treatments and Ongoing Clinical Trials Related ReportsAcute Gout Flare MarketDelveInsight's "Acute gout Flare - Market Insights, Epidemiology, and Market Forecast-2030" report. Chronic Refractory Gout MarketDelveInsight's "Chronic Refractory Gout - Market Insights, Epidemiology, and Market Forecast-2030" report. Gout MarketDelveInsight's "Gout - Market Insights, Epidemiology, and Market Forecast-2030" report. Hyperkalemia Japan MarketDelveInsight’s ‘Hyperkalemia —Market Insights, Epidemiology, and Market Forecast–2030’ report. Acute Pancreatitis Market SizeDelveInsight's "Acute Pancreatitis (AP) Market Insights, Epidemiology and Market Forecast-2028" report. Browse through blog postsAngelman syndrome PipelineAutoimmune Diseases Market and Key Pharma Players Involved About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.  Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. For more insights, visit Pharma, Healthcare, and Biotech News