Bentracimab

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

Bentracimab is designed to reverse the antiplatelet activity of ticagrelor. Credit: aodaodaodaod on Shutterstock.com. Speciality pharmaceutical company SERB Pharmaceuticals has acquired exclusive US rights for bentracimab from SFJ Pharmaceuticals. SFJ Pharmaceuticals will lead the ongoing clinical trial of bentracimab. Recommended Reports Reports COVID-19: Contract Pharmaceutical Development and Manufacturing Relationships GlobalData Reports Global Mergers and Acquisitions (M&A) Deals in Pharma 2021 - Thematic Research GlobalData View all In partnership with SERB Pharmaceuticals, the company will also file a biologics licence application (BLA) to the US Food and Drug Administration (FDA) later this year. The new monoclonal antibody fragment bentracimab is designed to reverse the antiplatelet activity of ticagrelor, a reversible oral P2Y12 platelet inhibitor. Marketed as Brilinta by AstraZeneca, ticagrelor has been developed for heart attack or stroke patients and those with acute coronary syndromes and coronary artery disease (CAD). Subject to receiving FDA approval, bentracimab will allow these patients to benefit from the antithrombotic effect of ticagrelor, helping to reduce the death risk and preventing vascular events. SERB Pharmaceuticals executive chairman Jeremie Urbain stated: “The acquisition of bentracimab marks a significant step in our strategy to grow through investment in innovative biologic products for critical care conditions and leverages our existing commercial and technical capabilities. “We’re excited to partner with SFJ, recognised leaders in late-stage drug development, to bring this life-saving medicine to healthcare professionals and the patients they treat.” Interim analysis from the ongoing Phase III REVERSE-IT trial showed that bentracimab quickly and sustainably reversed ticagrelor’s antiplatelet effects. It was found to be well-tolerated, with only minor adverse events observed. The US FDA granted breakthrough therapy designation to bentracimab in 2019.