Pharma Focus Asia

Y-mAbs and Takeda Announce Exclusive License and Distribution Agreement for DANYELZA® (naxitamab-gqgk) and Omburtamab in Israel

Saturday, December 05, 2020

Y-mAbs Therapeutics, Inc. a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer and Takeda Israel, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited announced today that they have entered into an exclusive license and distribution agreement for the registration and commercialization in Israel of DANYELZA for the treatment of patients with relapsed/refractory high-risk neuroblastoma and omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. DANYELZA (naxitamab-gqgk) was approved by the U.S. FDA on November 25, 2020. Additionally, Y-mAbs plans to resubmit the amended BLA for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma to the FDA by the end of 2020 or in early 2021.

Under the terms of the agreement, Takeda will employ its proven platform of sales, access, marketing and regulatory expertise to distribute DANYELZA and omburtamab, if approved, in the territory. The license and distribution agreement includes the State of Israel, West Bank and Gaza Strip. All other geographies worldwide remain with the Company. Financial details were not disclosed.

“We are very pleased to enter into this license and distribution agreement with Takeda, and now expect to see a treatment cluster established in the Middle East, thereby making DANYELZA and omburtamab, if approved, available to children with unmet medical needs in the region,” said Thomas Gad, founder, Chairman and President at Y-mAbs.

Arie Kramer, General Manager at Takeda further notes, “Relapsed/refractory high-risk neuroblastoma and CNS/leptomeningeal metastasis from neuroblastoma are cancers for which there are currently no approved therapies in Israel, and we are excited to partner with Y-mAbs, making these compounds available and bringing new hopes to pediatric patients suffering from these devastating conditions in Israel.”

Researchers at 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.

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