PARIS, March 20, 2024 /PRNewswire/ --
"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.
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. 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 https://SERB.com. 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. 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
Larisa Bernstein, Global Head of Communications
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. Voraxaze® US indication and limitations of use 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
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. Please see the full Prescribing Information.
Contact: Gabriela Arellano
Telephone: (+52) 1 5544423498
Email: gabriela.arellano@moksha8.com
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