On May 19, 2021 Y-mAbs Therapeutics, Inc. (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 reported that it has entered into an exclusive distribution agreement with Adium Pharma S.A. ("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 (Press release, Y-mAbs Therapeutics, MAY 19, 2021, View Source [SID1234580428]).

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DANYELZA (naxitamab-gqgk) 40mg/10mL was approved by the U.S. Food and Drug Administration ("FDA") on November 25, 2020 and 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.

Omburtamab is an investigational, monoclonal antibody that targets B7-H3 and is radiolabeled before intraventricular administration. B7-H3 is an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. 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. 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.

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. Under the terms of the agreement, Adium will employ its sales and marketing expertise to distribute DANYELZA and omburtamab, if approved, in the territory. In addition, Adium will submit registration files on behalf of the Company in certain parts of the territory. All other unpartnered geographies worldwide remain with the Company. Financial details were not disclosed.

"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. 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.

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed DANYELZA and omburtamab, which are exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compounds and in Y-mAbs.

About DANYELZA (naxitamab-gqgk)

DANYELZA (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. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. 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. See full Prescribing Information for complete Boxed Warning and other important safety information.