Glucarpidase

PARIS, March 20, 2024 /PRNewswire/ -- M8 Pharmaceuticals, an Acino company ("M8") and SERB Pharmaceuticals ("SERB"), a global specialty pharmaceutical company, are collaborating to bring an important drug for cancer patients to Latin America. Under the agreement, M8 will 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. Through this collaboration a larger number of patients in urgent need will benefit from life-saving treatments in underserved areas. 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. For further information contact: Chris Sampson, Director, Corporate Communications and ESG [email protected] Larisa Bernstein, Global Head of Communications [email protected] 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. Contact: Gabriela Arellano Telephone: (+52) 1 5544423498 Email: gabriela.arellano@moksha8.com Logo - SOURCE M8 Pharmaceuticals

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