On November 4, 2024 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, and Nobelpharma Co., Ltd. reported that they have entered into an exclusive license and distribution agreement for the development and commercialization in Japan of DANYELZA for the treatment of patients with relapsed/refractory high-risk neuroblastoma and, upon agreement by the parties, potentially relapsed osteosarcoma (Press release, Y-mAbs Therapeutics, NOV 4, 2024, View Source [SID1234647672]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, Nobelpharma will employ its regulatory, marketing, sales and access expertise to carry out development work and to submit DANYELZA for approval by Japanese regulatory authorities, and to market, sell, and distribute DANYELZA in Japan, if approved. Pursuant to the agreement, Y-mAbs will receive an upfront payment of $2.0 million from Nobelpharma in connection with entering into the agreement and is entitled to receive up to $31.0 million in product and commercial milestone payments in addition to royalties in the low double digits on commercial sales on DANYELZA, if successfully approved and commercialized in Japan.

"Our exclusive license and distribution agreement with Nobelpharma in Japan is an important step in our continued global expansion efforts of DANYELZA," said Michael Rossi, President and Chief Executive Officer of Y-mAbs. "If approved in the region, we believe DANYELZA can deliver a meaningful impact to patients in Japan fighting relapsed/refractory high-risk neuroblastoma and improve long-term quality of life for these children."

"We believe that Nobelpharma is the right partner for Y-mAbs in Japan, and we are excited to work with Nobelpharma towards the potential approval and commercial launch of DANYELZA in the region," said Thomas Gad, Founder and Chief Business Officer of Y-mAbs. "DANYELZA, if approved in Japan for relapsed/refractory high-risk neuroblastoma, will provide a new out-patient anti-GD2 therapeutic option for physicians in the treatment of children facing this advanced form of pediatric cancer. We remain steadfast in our commitment to provide access to DANYELZA and improve the lives of children and families around the globe facing advanced cancers."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed DANYELZA (naxitamab-gqgk), which is exclusively licensed by MSK to Y-mAbs. MSK has institutional financial interests in the compound and 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.

DANYELZA is currently not approved for the treatment of osteosarcoma in any jurisdiction.