BTG International, Inc.

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

DUBLIN--( BUSINESS WIRE )--The "Surgical Devices Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2022 Update" report has been added to ResearchAndMarkets.com's offering. This report provides comprehensive information about the Surgical Devices pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress. Report Scope Extensive coverage of the Surgical Devices under development The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities The report reviews the major players involved in the development of Surgical Devices and list all their pipeline projects The coverage of pipeline products based on various stages of development ranging from Early Development to Approved/Issued stage The report provides key clinical trial data of ongoing trials specific to pipeline products Recent developments in the segment/industry The report enables you to: Formulate significant competitor information, analysis, and insights to improve R&D strategies Identify emerging players with potentially strong product portfolio and create effective counter strategies to gain competitive advantage Identify and understand important and diverse types of Surgical Devices under development Develop market-entry and market expansion strategies Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline In-depth analysis of the product's current stage of development, territory and estimated launch date Key Topics Covered 1 Table of Contents 1.1 List of Tables 1.2 List of Figures 2 Introduction 2.1 Surgical Devices Overview 3 Products under Development 3.1 Surgical Devices - Pipeline Products by Stage of Development 3.2 Surgical Devices - Pipeline Products by Segment 3.3 Surgical Devices - Pipeline Products by Territory 3.4 Surgical Devices - Pipeline Products by Regulatory Path 3.5 Surgical Devices - Pipeline Products by Estimated Approval Date 3.6 Surgical Devices - Ongoing Clinical Trials 4 Surgical Devices - Pipeline Products under Development by Companies 4.1 Surgical Devices Companies - Pipeline Products by Stage of Development 4.2 Surgical Devices - Pipeline Products by Stage of Development 5 Surgical Devices Companies and Product Overview 6 Surgical Devices - Recent Developments 7 Appendix 7.1 Methodology List of Tables Surgical Devices - Pipeline Products by Stage of Development Surgical Devices - Pipeline Products by Segment Surgical Devices - Pipeline Products by Territory Surgical Devices - Pipeline Products by Regulatory Path Surgical Devices - Pipeline Products by Estimated Approval Date Surgical Devices - Ongoing Clinical Trials Surgical Devices Companies - Pipeline Products by Stage of Development Surgical Devices - Pipeline Products by Stage of Development Glossary List of Figures Surgical Devices - Pipeline Products by Stage of Development Surgical Devices - Pipeline Products by Segment Surgical Devices - Pipeline Products by Territory Surgical Devices - Pipeline Products by Regulatory Path Surgical Devices - Pipeline Products by Estimated Approval Date Surgical Devices - Ongoing Clinical Trials Companies Mentioned 6S Medical LLC Abbott Operations Uruguay Srl Acoustic MedSystems Inc Aesculap Inc Anastom Surgical Anchora Medical Ltd Apercure Surgical Ltd Apollo Endosurgery Inc Applied Medical Resources Corporation Apyx Medical Corp Archon Medical Technologies LLC Augusta University Baxter International Inc BioTex Inc BriteSeed BTG International Inc Carnegie Mellon University Centre Hospitalier Universitaire de Nice Charite University Hospital of Berlin Chengdu Yurui Innovation Technology Co Ltd Colospan Ltd Control Medical Technology LLC Core Essence Orthopaedics, LLC Corporis Medical Covidien Ltd CR Bard Inc Creative Balloons GmbH Cryofocus Medtech Shanghai Co Ltd CT Resources Inc Cutera Inc Cypris Medical, Inc. Dartmouth College Deep Blue Medical Advances Inc Drexel University Emblation Ltd Embricon Ltd (Inactive) Endo Tools Therapeutics SA EndoEvolution, LLC Ethicon Endo-Surgery Inc ExpandoHeat LLC Fixit Medical Ltd Fogless International AB G.I. Windows Inc Galil Medical Ltd Garantis Genicon Inc GI Windows Medical Corp Grand Valley State University H. Lee Moffitt Cancer Center & Research Institute Inc Hangzhou Kangsheng Medical Equipment Co Ltd Hannover Medical School Harvard University Hospital for Special Surgery IceCure Medical Ltd Imperial College London Indian Institute of Technology Delhi Innovex Medical Co Ltd Integra LifeSciences Holdings Corp Intuitive Surgical Inc IonMed Ltd. Jinan Micro Intelligent Technology Co Ltd Johns Hopkins University Keren Medical Ltd. LeMaitre Vascular Inc Livsmed Inc LuSeed Vascular Lymphatica Medtech SA MagniFeel Surgical Instruments Mayo Clinic Mecmaan Healthcare Ltd Medical University of South Carolina MediShield B.V. Medtronic Plc Mel Frontier Co Ltd Meta Biomed Co Ltd Michigan State University Naval Medical Research Center Next Science Ltd NorthShore University Health System NOvate Medical Technologies, LLC NoviRad Inc NovoGI LTD Novolock Ltd Novuson Surgical, Inc. Ohio State University Oklahoma State University Olympus America Inc OV World Co Ltd Pacira BioSciences Inc Parker Hannifin Corp Pavmed Inc PetVivo Holdings Inc Physcient, Inc. Polytechnic University of Catalonia Pro-Dex Inc Queen Mary University of London Ra Medical Systems Inc Ramona Optics Inc Ratner BioMedical Inc Resultados y Calidad del Sistema Sanitario Publico de Andalucia Rice University Saint Louis University Samyang Biopharmaceuticals Corp Sanovas Inc Shanghai MicroPort Medical Group Co Ltd Shanghai Shengzhe Medical Technology Co Ltd Shanghai Yichao Medical Equipment Co Ltd Silmag SA simedeq Simon Fraser University StatLink Surgical STRATA Skin Sciences Inc Stryker Corp SurgyAid, LLC Sutura Inc Teleflex Inc Tepha Inc The Feinstein Institute for Medical Research TransMed7 LLC Trinity College Dublin University of Auckland University of California University of California Davis University of California Los Angeles University of California San Diego University of Central Florida University of Chicago University of Maryland University of Maryland Baltimore University of Minnesota University of Missouri University of North Carolina University of South Florida University of Strasbourg University of Texas at Austin University of Texas Medical Branch at Galveston University of Toledo University of Utah University of Virginia US Medical Innovations LLC USGI Medical Inc Vanderbilt University Vascular Insights LLC VB Devices Vessi Medical Ltd Viveve Medical Inc Viveve, Inc. Wake Forest Baptist Medical Center Weill Cornell Medical College West Virginia University X-Biomedical Inc For more information about this report visit https://www.researchandmarkets.com/r/ekyrrp Source: GlobalData

Neuronal Inflammation was found in two U.S. monkeypox patients, researchers short-list four drugs for potential study in autism, a new test can predict immunotherapy outcomes and a new radiopharmaceutical venture is born. Two Cases of Monkeypox-related Neuronal Inflammation Reported Two monkeypox patients in the U.S., one in Colorado and one in Washington, DC, have developed encephalomyelitis, or inflammation of the brain and spinal cord. The neurological complications developed one week after the onset of their symptoms for both individuals, suggesting the inflammation may be the outcome of their monkeypox infections. The cases were reported Tuesday in Morbidity and Mortality Weekly Report. The Colorado-based patient is an immunocompetent, gay man in his 30s with no known monkeypox exposure or international travel. Nine days after symptom onset he developed progressive left arm and leg weakness and numbness followed by urinary retention issues and intermittent priapism. He was hospitalized shortly after these symptoms began and treated with Tpoxx. Weakness in his left leg lasted over one month during which he required walking assistance. The DC case belonged to an otherwise healthy gay man in his 30s who similarly had no known exposure to monkeypox or recent travel. His abnormal symptoms began five days after the original monkeypox symptom onset. He experienced similar symptoms to the first patient, with bowel and bladder incontinence and progressive weakness in both legs. He was hospitalized and eventually intubated and admitted to the ICU. He was treated with Tpoxx and later rituximab, a monoclonal antibody medication. “The underlying pathology behind this is unclear but might represent either MPXV invasion of the [central nervous system] or a parainfectious autoimmune process triggered by systemic MPXV infection,” the study authors stated. While rare, outcomes similar to these were seen during smallpox outbreaks centuries ago, the Center for Infectious Disease Research and Policy noted. Researchers Shortlist Four Drugs for Study in Autism Researchers have found four drugs that, while currently used to treat other disorders, may be useful in treating the core symptoms of autism spectrum disorder (ASD). ASD is characterized by social and communication deficits. It is known to be highly hereditary and clinically heterogeneous. As of now, there are no medications approved for the treatment of these primary symptoms. The researchers, from the University of Oslo and Aarhus University in Denmark, studied ASD risk genes within networks of protein-protein interactions of gene products. The aim was to evaluate if various drugs, typically used to treat other disorders and symptoms, may change the ASD-associated gene expression in this network. The logic behind this process was that if a drug did change the expression, it could be used to treat core ASD symptoms, and should be further investigated. The researchers narrowed their list of potential drugs down to four: Loperamide, bromocriptine, drospirenone and progesterone. These drugs act on ASD-related biological systems, indicating they could be useful in treating the core symptoms of ASD. In conclusion, the researchers shortlisted these four drugs for potential clinical translation in ASD. Single Test can Predict Immunotherapy Outcomes Researchers at NYU Grossman School of Medicine’s Perlmutter Cancer Center have identified a single test with the potential to predict severe side effects and recurrence in patients treated with immunotherapy. The test centers around autoantibodies found in a patient’s blood prior to immunotherapy. The human body recognizes tumors as abnormal. But, the cancerous cell hijacks the body’s defense checkpoints and turns off the immune attack at the PD-1 receptor (programmed death receptor 1). PD-1 inhibitors have been effective against many cancers but many patients still experience disease recurrence and severe treatment-related side effects, the researchers noted. Studying two checkpoint inhibitors, Bristol Myers Squibb’s Opdivo (nivolumab) and Yervoy (ipilimumab), the team identified a panel of distinct autoantibody signatures with the ability to predict immune-related adverse effects. While the data support the predictive nature of these autoantibody scores, more research is needed before the test can be used in clinical settings, the researchers said. Radiopharm Ventures Launches The University of Texas MD Anderson Cancer Center and Radiopharm Theranostics have launched Radiopharm Ventures to develop radiopharmaceutical therapeutics for the treatment of cancer. "Radiopharmaceuticals continue to be rapidly developed as a highly promising therapeutic frontier in oncology," said Riccardo Canevari, chief executive officer of the new venture in a statement. Radiopharmaceuticals work by delivering small doses of radiation to specific cell targets for therapeutic or diagnostic purposes. The process requires tumor-specific targets. MD Anderson brings novel platforms to discover and validate tumor-specific antigens, the companies stated. A humanized immunoglobulin G (IgG) antibody targeting the tumor-specific antigen B7-H3 (CD276) was presented as the potential first candidate. The radiotherapeutic antibody has shown evidence of efficacy in eliminating resistant colorectal cancers in laboratory models.