Y-mAbs and Nobelpharma Announce Exclusive License and Distribution Agreement for DANYELZA® (naxitamab-gqgk) in Japan
Y-mAbs Therapeutics (NASDAQ: YMAB) and Nobelpharma have signed an exclusive license and distribution agreement for DANYELZA® in Japan. The agreement covers the development and commercialization of DANYELZA for treating relapsed/refractory high-risk neuroblastoma and potentially relapsed osteosarcoma. Y-mAbs will receive a $2.0 million upfront payment and could earn up to $31.0 million in milestone payments, plus profit sharing on commercial sales. Nobelpharma will handle regulatory submissions, marketing, sales, and distribution in Japan.
Y-mAbs Therapeutics (NASDAQ: YMAB) e Nobelpharma hanno firmato un accordo esclusivo di licenza e distribuzione per DANYELZA® in Giappone. L'accordo comprende lo sviluppo e la commercializzazione di DANYELZA per il trattamento del neuroblastoma ad alto rischio in recidiva/refrattario e potenzialmente del osteosarcoma in recidiva. Y-mAbs riceverà un pagamento iniziale di 2,0 milioni di dollari e potrebbe guadagnare fino a 31,0 milioni di dollari in pagamenti legati a traguardi, oltre alla condivisione dei profitti sulle vendite commerciali. Nobelpharma si occuperà delle presentazioni normative, del marketing, delle vendite e della distribuzione in Giappone.
Y-mAbs Therapeutics (NASDAQ: YMAB) y Nobelpharma han firmado un acuerdo exclusivo de licencia y distribución para DANYELZA® en Japón. El acuerdo abarca el desarrollo y la comercialización de DANYELZA para el tratamiento del neuroblastoma de alto riesgo en recaída/refractario y potencialmente del osteosarcoma en recaída. Y-mAbs recibirá un pago inicial de 2,0 millones de dólares y podría ganar hasta 31,0 millones de dólares en pagos por hitos, además de compartir las ganancias de las ventas comerciales. Nobelpharma se encargará de las presentaciones regulatorias, el marketing, las ventas y la distribución en Japón.
Y-mAbs Therapeutics (NASDAQ: YMAB)와 Nobelpharma가 일본에서의 DANYELZA®에 대한 독점 라이센스 및 배급 계약을 체결했습니다. 이 계약은 재발/난치성 고위험 신경모세포종 치료 및 잠재적인 재발 뼈육종에 대한 DANYELZA의 개발 및 상용화를 포함합니다. Y-mAbs는 200만 달러의 선불금을 수령하고, 최대 3100만 달러의 마일스톤 지급금과 상업 판매의 이익 공유를 받을 수 있습니다. Nobelpharma는 일본에서의 규제 제출, 마케팅, 판매 및 배급을 담당합니다.
Y-mAbs Therapeutics (NASDAQ: YMAB) et Nobelpharma ont signé un accord de licence et de distribution exclusif pour DANYELZA® au Japon. Cet accord couvre le développement et la commercialization de DANYELZA pour traiter le neuroblastome à haut risque récurrent/réfractaire et potentiellement l'ostéosarcome récurrent. Y-mAbs recevra un paiement initial de 2,0 millions de dollars et pourrait gagner jusqu'à 31,0 millions de dollars en paiements de jalons, en plus du partage des bénéfices sur les ventes commerciales. Nobelpharma se chargera des soumissions réglementaires, du marketing, des ventes et de la distribution au Japon.
Y-mAbs Therapeutics (NASDAQ: YMAB) und Nobelpharma haben einen exklusiven Lizenz- und Vertriebsvertrag für DANYELZA® in Japan unterzeichnet. Der Vertrag umfasst die Entwicklung und Vermarktung von DANYELZA zur Behandlung von rezidiviertem/refraktärem hochriskantem Neuroblastom sowie potenziell rezidiviertem Osteosarkom. Y-mAbs erhält eine Vorauszahlung von 2,0 Millionen Dollar und kann bis zu 31,0 Millionen Dollar an Meilensteinzahlungen sowie eine Gewinnbeteiligung an den Geschäftserlösen erwirtschaften. Nobelpharma wird die regulatorischen Einreichungen, das Marketing, den Verkauf und die Distribution in Japan übernehmen.
- Secured $2.0 million upfront payment from Nobelpharma
- Potential to earn up to $31.0 million in milestone payments
- Additional revenue stream through profit sharing on commercial sales
- Geographic expansion into Japanese market
- Product approval in Japan not guaranteed
- Revenue dependent on successful commercialization
Insights
This licensing agreement marks a significant strategic expansion for Y-mAbs into the Japanese market. The deal structure includes an immediate
The Japanese market represents a substantial opportunity for DANYELZA, especially considering Japan's advanced healthcare system and favorable reimbursement policies for innovative cancer treatments. Nobelpharma's local market knowledge and established presence significantly reduce Y-mAbs' market entry risks and capital requirements while potentially accelerating the path to commercialization.
DANYELZA's potential expansion into Japan is medically significant as it addresses a critical unmet need in treating relapsed/refractory high-risk neuroblastoma. The outpatient administration capability of this anti-GD2 therapy could represent a meaningful advancement in treatment accessibility and patient comfort compared to existing options in Japan. The possible expansion into relapsed osteosarcoma treatment further enhances the product's market potential and therapeutic value proposition.
NEW YORK, Nov. 04, 2024 (GLOBE NEWSWIRE) -- 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. today announced 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.
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
“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.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, radioimmunotherapy and antibody-based therapeutic cancer products. The Company’s technologies include its investigational Self-Assembly DisAssembly (“SADA”) Pretargeted Radioimmunotherapy Platform (“PRIT”) and bispecific antibodies generated using the Y-BiClone platform. The Company’s broad and advanced product pipeline includes the anti-GD2 therapy DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow after a partial response, minor response, or stable disease to prior therapy.
Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, statements about expectations relating to the Company’s partnership with Nobelpharma, including the development process and regulatory submissions with respect to the potential approval and commercialization of DANYELZA in Japan and the potential indications thereof; the receipt by the Company of any payments or royalties from Nobelpharma; and other statements that are not historical facts. Words such as ‘‘anticipate,’’ ‘‘believe,’’ “contemplate,” ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ “hope,” ‘‘intend,’’ ‘‘may,’’ ‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘target,’’ “will,” ‘‘would’,’ “guidance,” “goal,” “objective,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with the Company’s reliance on a third-party for development work associated with the regulatory process with respect to and potential commercialization of DANYELZA in Japan; cost and success of the Company’s and Nobelpharma’s product development activities and clinical trials; the risks of delay in the timing of the Company’s and Nobelpharma’s regulatory submissions or failure to receive approval of DANYELZA in Japan; and the risks related to commercializing any approved pharmaceutical product in a territory, including with respect to the rate and degree of market acceptance. All statements are subject to the risks described in the “Risk Factors” section included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and the Company’s Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2024 and June 30, 2024, and future filings and reports by the Company. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
DANYELZA® and Y-mAbs® are registered trademarks of Y-mAbs Therapeutics, Inc.
Investor Contact:
Courtney Dugan
VP, Head of Investor Relations
cdu@ymabs.com
FAQ
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