Glucarpidase

Paris, March 20, 2024 (GLOBE NEWSWIRE) -- SERB Pharmaceuticals (“SERB”), a global specialty pharmaceutical company, and M8 Pharmaceuticals, an Acino company (“M8”) are collaborating to bring an important drug for cancer patients to Latin America. Under the agreement, M8 Pharmaceuticals is licensed to register, market and commercialize SERB’s supportive oncology product Voraxaze® (glucarpidase) in Latin America. Voraxaze® is a carboxypeptidase that reduces toxic plasma methotrexate concentration in adults and children with delayed methotrexate elimination or at risk of methotrexate toxicity. Only Voraxaze® can lower methotrexate (MTX) levels by ≥97% in 15 minutes, reducing the risk for severe toxicities and death.1-3 Voraxaze® is approved in the US, where it has been available since 2012, as well as in Europe and Japan. In the US Voraxaze® is included in the National Comprehensive Cancer Network guidelines. “We are proud to partner with M8, a company that shares our passion for addressing unmet patient needs. Together, we will ensure this critical medicine becomes accessible to patients across Latin America,” said Antoine Bernasconi, Executive VP and Chief Commercial Officer for EMEA/International at SERB. “Bringing this important product to Latin America represents an important step in our global expansion and our ambition to help more patients around the world.” “We are delighted to start this significant collaboration with SERB It enables M8 to offer Latin American patients solutions for high medical needs, while leveraging SERB's expertise in treating complex and life-threatening conditions,” said Joel Barlan, Head of Latin America at Acino. This strategic partnership aligns with M8’s mission to provide the people of Latin America with access to innovative medicines and strengthen its presence within onco-hematology and rare diseases in the region. Collaboration with M8 will enable the treatments to reach more patients in underserved areas, ensuring more people in urgent need will have access to innovative medicines. About High Dose Methotrexate Toxicity High Dose Methotrexate (HDMTX) chemotherapy is used to treat or prevent the recurrence of certain types of cancer in adults and children, such as leukemia, lymphoma, and osteosarcoma. Despite standard supportive measures, HDTMX may induce renal dysfunction in some patients, delaying MTX elimination. This may result in sustained elevated levels of MTX concentration, which in turn may cause acute renal toxicity and other systemic adverse reactions that do not respond to standard doses of first-line therapy. Where approved, administering Voraxaze® may quickly lower MTX levels and avoid further systemic damage. It breaks down methotrexate into inactive metabolites, which are then eliminated from the body by routes other than the kidney – primarily the liver. Voraxaze® is the only drug able to reduce toxic plasma methotrexate levels. Voraxaze® is not currently registered in Latin American territories. 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 M8 Pharmaceuticals, an Acino company M8 is a specialty biopharmaceutical company focused on licensing, marketing, and distributing innovative and established therapeutics in Latin America. We aim to become the preferred pharmaceutical partner for licensing high-value, innovative, and proven therapies across our main therapeutic areas: CNS, respiratory, cardiometabolic, immunology, gastroenterology, onco-hematology, and rare diseases. Our mission is to provide the people of Latin America with access to the innovative and proven medicines they need to transform their lives. In December 2023, M8 was acquired by Acino, a Swiss pharmaceutical company headquartered in Zurich. About Acino Acino is a Swiss pharmaceutical company headquartered in Zurich with a clear focus on selected markets in the Middle East, Africa, Ukraine, the CIS Region, and Latin America. Acino is part of ADQ, an Abu Dhabi-based investment and holding company. We deliver quality pharmaceuticals to promote affordable healthcare in these markets. We leverage our high-quality pharmaceutical manufacturing capabilities and network to supply leading companies through contract manufacturing and out-licensing. Chris Sampson, Director, Corporate Communications and ESG Chris.Sampson@serb.com Larisa Bernstein, Global Head of Communications larisa.bernstein@acino.swiss References: 1.Widemann BC, Balis FM, Kim A, et al. Glucarpidase, leucovorin, and thymidine for high-dose methotrexate-induced renal dysfunction: clinical and pharmacologic factors affecting outcomes. J Clin Oncol. 2010;28(25):3979-3986. 2.Howard SC, McCormick J, Pui CH, Buddington RK, Harvey RD. Preventing and managing toxicities of high-dose methotrexate. Oncologist. 2016;21(12):1471-1482. 3. Voraxaze®. Prescribing information. BTG International Inc.; 2019. Voraxaze® US indication and limitations of use Voraxaze® is a carboxypeptidase indicated to reduce toxic plasma methotrexate concentration (greater than 1 micromole per liter) in adult and pediatric patients with delayed methotrexate clearance (plasma methotrexate concentrations greater than 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered) due to impaired renal function. Limitations of Use: Voraxaze® is not recommended in patients who exhibit the expected clearance and plasma methotrexate concentration. Reducing plasma methotrexate concentration in these patients may result in subtherapeutic exposure to methotrexate. Important safety information Warnings and precautions Serious Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic reactions, may occur. Serious hypersensitivity reactions occurred in less than 1% of patients Monitoring Methotrexate Concentration/Interference with Assay Methotrexate concentrations within 48 hours following Voraxaze® administration can only be reliably measured by a chromatographic method due to metabolite interference. Measurement of methotrexate concentrations within 48 hours of Voraxaze® administration using immunoassays results in an overestimation of the methotrexate concentration. Adverse reactions In clinical trials, the most common related adverse events (occurring in >1% of patients) were paresthesia, flushing, nausea and/or vomiting, hypotension, and headache. Drug interactions Voraxaze® can decrease leucovorin concentration, which may decrease the effect of leucovorin rescue unless leucovorin is dosed as recommended, and may also reduce the concentrations of other folate analogs or folate analog metabolic inhibitors. Please see the full Prescribing Information. Christopher W Sampson SERB Pharmaceuticals +44 7773 251 178 chris.sampson@serb.com

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