Exclusive License Agreement Between Y-mAbs Therapeutics, Inc. and Nobelpharma Co., Ltd. for Development and Commercialization of DANYELZA(R) in Japan

Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB) recently announced a significant milestone achieved through its entry into a License Agreement with Nobelpharma Co., Ltd. The agreement, effective from October 23, 2024, grants Nobel an exclusive license for the development and commercialization of DANYELZA(R) or related formulations of naxitamab for treating patients with neuroblastoma and potentially relapsed osteosarcoma in Japan.

As part of the agreement, Y-mAbs will provide Nobel access to certain patents, know-how, and regulatory materials related to the Licensed Product to aid in its regulatory approval processes. Nobel is committed to driving the development of the product necessary for regulatory approval in Japan, with Y-mAbs agreeing to cover 50% of specific development costs for a Phase 1 study required for this purpose.

Nobelpahrma will make an upfront payment of $2.0 million to Y-mAbs, with additional milestone payments of up to $31.0 million based on specific achievements related to product and commercial milestones. Moreover, low double-digit royalty payments on net sales of the Licensed Product in Japan are also part of the agreement terms.

The License Agreement has provisions for termination by either party and outlines conditions under which the agreement can be terminated, including in case of material breaches, insolvency events, or safety issues arising with the product.

In conjunction with this agreement, Y-mAbs issued a press release on November 4, 2024, announcing this strategic collaboration. This press release, detailing the License Agreement, was included as Exhibit 99.1 in a Form 8-K filing to the Securities and Exchange Commission (SEC) by Y-mAbs.

The agreement aligns with Y-mAbs’ global expansion strategy, aiming to extend the reach of DANYELZA(R) to patients in Japan facing neuroblastoma and potentially osteosarcoma, offering a new treatment option in these critical conditions.

DANYELZA(R) is designed for patients with relapsed or refractory high-risk neuroblastoma, demonstrating the Company’s commitment to advancing innovative treatments in the oncology space. The therapy is integrated with granulocyte-macrophage colony-stimulating factor (“GM-CSF”), focusing on specific patient groups and offering potential clinical benefits.

Y-mAbs remains dedicated to its mission of addressing unmet medical needs in pediatric oncology and improving outcomes for patients globally. The License Agreement signifies a pivotal step towards enhancing access to advanced therapies for patients in Japan and underscores the Company’s commitment to innovation and partnership in the oncology landscape.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Y-mAbs Therapeutics’s 8K filing here.

About Y-mAbs Therapeutics

Y-mAbs Therapeutics, Inc, a commercial-stage biopharmaceutical company, focuses on the development and commercialization of antibody based therapeutic products for the treatment of cancer in the United States and internationally. It offers DANYELZA, a monoclonal antibody in combination with granulocyte-macrophage colony-stimulating factor for the treatment of pediatric patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow.