Y-mAbs Enters into Agreement with Nobelpharma for Exclusive DANYELZA® Licensing in Japan
Tuesday, November 05, 2024
Y-mAbs Therapeutics has entered an exclusive licensing and distribution agreement with Nobelpharma.
This partnership aims to develop and potentially commercialise DANYELZA for the treatment of relapsed or refractory high-risk neuroblastoma in Japan, and potentially, with further agreement, for relapsed osteosarcoma.
Under the terms of the agreement, Nobelpharma will apply its regulatory, marketing, and distribution expertise to facilitate DANYELZA’s development, secure approval from Japanese health authorities, and manage the product’s marketing, sales, and distribution across Japan, should approval be granted.
In connection with this collaboration, Y-mAbs will receive an initial payment of $2 million from Nobelpharma, with further potential earnings of up to $31 million based on product and commercial milestones, along with profit sharing on commercial sales in Japan if DANYELZA achieves regulatory approval and launch.
DANYELZA (naxitamab-gqgk) was developed at Memorial Sloan Kettering Cancer Center (MSK) and is exclusively licensed to Y-mAbs, with MSK holding institutional financial interests in both the compound and Y-mAbs.
This treatment, when combined with granulocyte-macrophage colony-stimulating factor (GM-CSF), is intended for patients aged 1 year and older with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow.
It is approved under accelerated approval based on response rate and duration, with continued approval contingent on confirmatory trials to verify clinical benefit.
Notably, DANYELZA carries a Boxed Warning for serious infusion-related and neurotoxicity risks, including cardiac arrest and severe neuropathic pain.
Currently, DANYELZA has not been approved for osteosarcoma treatment in any jurisdiction.
Source: ymabs.com
