On December 18, 2020 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 a distribution agreement with Swixx BioPharma AG ("Swixx") to be the exclusive distributor 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 in Eastern Europe, including Russia (Press release, Y-mAbs Therapeutics, DEC 18, 2020, View Source [SID1234573081]). 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. The Company plans to resubmit its ("BLA") to the FDA for omburtamab by the end of 2020 or in early 2021.
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The distribution agreement includes the European territories of Bosnia & Herzegovina, Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Russia, Serbia, Slovakia and Slovenia. Under the terms of the agreement, Swixx will employ its sales and marketing expertise to distribute DANYELZA and omburtamab, if approved, in the territory. In addition, Swixx will submit registration files on behalf of Y-mAbs 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 Swixx, and hope to see a DANYELZA and omburtamab, if approved, being made available to appropriate children with unmet medical needs in Eastern Europe and Russia," 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.