Adium distributes its products in 18 Latin American & Caribbean countries including Brazil, Mexico and Colombia. The Company has a broad and advanced product pipeline, including one FDA approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one pivotal-stage product candidate, omburtamab, which targets tumors that express B7-H3.Īdium is a private pharmaceutical company based in Montevideo, Uruguay. Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer.
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See full Prescribing Information for complete Boxed Warning and other important safety information. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis.
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Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. This indication was approved under accelerated approval based on overall response rate and duration of response. As a result of this licensing arrangement, MSK has institutional financial interests in the compounds and in Y-mAbs.ĭANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. Researchers at Memorial Sloan Kettering Cancer Center (“MSK”) developed DANYELZA and omburtamab, which are exclusively licensed by MSK to Y-mAbs. We hope to leverage Adium’s footprint in Latin America to make DANYELZA and omburtamab, if approved, available to children with unmet medical needs,” said Thomas Gad, founder, Chairman and President at Y-mAbs. “We are very pleased to enter this distribution agreement with Adium, a company with a commercial presence in 18 countries and a sustained oncology and rare disease business. All other unpartnered geographies worldwide remain with the Company.
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In addition, Adium will submit registration files on behalf of the Company in certain parts of the territory. Under the terms of the agreement, Adium will employ its sales and marketing expertise to distribute DANYELZA and omburtamab, if approved, in the territory. The distribution agreement includes the territories of Argentina, Belize, Bolivia, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Uruguay, and certain Caribbean islands.
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The Company aims to resubmit its Biologics License Application (“BLA”) to the FDA for omburtamab by the end of the second quarter or in the third quarter 2021. In April 2021, the Company submitted a Marketing Authorization Application (“MAA”) to the European Medicines Agency for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. B7-H3 is an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. Omburtamab is an investigational, monoclonal antibody that targets B7-H3 and is radiolabeled before intraventricular administration. Food and Drug Administration (“FDA”) on Novemand is indicated, in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. (“Adium”) to be the exclusive distributor in Latin America of the Company’s antibodies, DANYELZA® (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma and omburtamab, if approved, for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma.ĭANYELZA (naxitamab-gqgk) 40mg/10mL was approved by the U.S. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer announced today that it has entered into an exclusive distribution agreement with Adium Pharma S.A. NEW YORK, (GLOBE NEWSWIRE) - Y-mAbs Therapeutics, Inc.
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