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Alteogen enters into an Exclusive License Agreement to Develop and Commercialize Subcutaneous ENHERTU® Enabled by Alteogen's Hybrozyme™ Technology

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Alteogen has entered into an exclusive license agreement with Daiichi Sankyo for the worldwide rights to use ALT-B4, Alteogen's novel hyaluronidase utilizing Hybrozyme™ Technology. The technology will be used to develop and commercialize a subcutaneous version of ENHERTU®, a HER2 directed antibody drug conjugate. The agreement includes an upfront payment and potential milestone payments for development, regulatory, and sales achievements, plus tiered royalties on commercialized product sales. Alteogen will be responsible for clinical and commercial supply of ALT-B4 to Daiichi Sankyo.

Alteogen ha stipulato un accordo di licenza esclusiva con Daiichi Sankyo per i diritti mondiali di utilizzo di ALT-B4, la nuova ialuronidasi di Alteogen che utilizza la tecnologia Hybrozyme™. Questa tecnologia sarà utilizzata per sviluppare e commercializzare una versione sottocutanea di ENHERTU®, un coniugato di farmaci a anticorpo diretto contro HER2. L'accordo prevede un pagamento iniziale e potenziali pagamenti per traguardi legati allo sviluppo, alla regolamentazione e ai risultati di vendita, oltre a diritti d'autore a livelli sui venduti commercializzati. Alteogen sarà responsabile della fornitura clinica e commerciale di ALT-B4 a Daiichi Sankyo.

Alteogen ha celebrado un acuerdo de licencia exclusiva con Daiichi Sankyo para los derechos mundiales de uso de ALT-B4, la novedosa hialuronidasa de Alteogen que utiliza la tecnología Hybrozyme™. La tecnología se utilizará para desarrollar y comercializar una versión subcutánea de ENHERTU®, un conjugado de anticuerpo dirigido contra HER2. El acuerdo incluye un pago inicial y pagos potenciales por hitos relacionados con el desarrollo, la regulación y logros en ventas, además de regalías escalonadas sobre las ventas de productos comercializados. Alteogen será responsable del suministro clínico y comercial de ALT-B4 a Daiichi Sankyo.

Alteogen은 Daiichi Sankyo와 ALT-B4에 대한 전세계 사용 권리를 위한 독점 라이센스 계약을 체결했습니다. ALT-B4는 Alteogen의 새로운 히알루로니다제이며, Hybrozyme™ 기술을 활용합니다. 이 기술은 ENHERTU®의 피하형을 개발하고 상업화하는 데 사용됩니다. 이 계약은 초기 지급금과 개발, 규제, 판매 성과에 대한 잠재적인 마일스톤 지급금을 포함하며, 상업화된 제품 판매에 대한 단계별 로열티 또한 포함됩니다. Alteogen은 Daiichi Sankyo에 ALT-B4의 임상 및 상업 공급을 책임집니다.

Alteogen a signé un accord de licence exclusif avec Daiichi Sankyo pour les droits mondiaux d'utilisation d'ALT-B4, la nouvelle hyaluronidase d'Alteogen utilisant la technologie Hybrozyme™. Cette technologie sera utilisée pour développer et commercialiser une version sous-cutanée de ENHERTU®, un conjugué d'anticorps dirigé contre HER2. L'accord comprend un paiement initial et des paiements potentiels pour des étapes liées au développement, à la réglementation et aux ventes, ainsi que des redevances dégressives sur les ventes des produits commercialisés. Alteogen sera responsable de l'approvisionnement clinique et commercial d'ALT-B4 à Daiichi Sankyo.

Alteogen hat einen exklusiven Lizenzvertrag mit Daiichi Sankyo über die weltweiten Rechte zur Nutzung von ALT-B4, Alteogens neuartiger Hyaluronidase, die die Hybrozyme™-Technologie verwendet, abgeschlossen. Die Technologie wird verwendet, um eine subkutane Version von ENHERTU®, einem HER2gerichteten Antikörper-Arzneimittel-Konjugat, zu entwickeln und zu commercialisieren. Der Vertrag umfasst eine Vorauszahlung sowie potenzielle Meilensteinzahlungen für Entwicklungs-, Regulierungs- und Verkaufserfolge, zusätzlich zu gestaffelten Lizenzgebühren auf die Verkäufe des commercialisierten Produkts. Alteogen wird für die klinische und kommerzielle Lieferung von ALT-B4 an Daiichi Sankyo verantwortlich sein.

Positive
  • Secured worldwide licensing agreement with major pharmaceutical company Daiichi Sankyo
  • Will receive upfront payment and milestone-based payments
  • Entitled to receive tiered royalties on future product sales
  • Secured commercial supply agreement for ALT-B4
Negative
  • None.

DAEJEON, South Korea, Nov. 10, 2024 /PRNewswire/ -- Alteogen Inc. (KOSDAQ:196170) announced today that the company has entered into an exclusive license agreement with Daiichi Sankyo (TSE: 4568). Under the terms of the agreement, Daiichi Sankyo will acquire world-wide rights to use ALT-B4, Alteogen's novel hyaluronidase utilizing Hybrozyme™ Technology, to develop and commercialize a subcutaneous version of ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody drug conjugate (ADC) that has been jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

Alteogen will receive an upfront payment and is eligible to receive milestone payments upon Daiichi Sankyo's achievement of specified development, regulatory and sales milestones. Additionally, Alteogen will be entitled to receive tiered royalties on the sales of the commercialized product. Alteogen will be responsible for clinical and commercial supply of ALT-B4 to Daiichi Sankyo.

"Our collaboration with Daiichi Sankyo is groundbreaking in the ADC field, being the first to use hyaluronidase for a subcutaneous ADC marks a significant milestone in the oncology field, and we look forward to our collaboration with Daiichi Sankyo in bringing this product to the market." said Dr. Soon Jae Park, Chief Executive Officer of Alteogen.

About ALT-B4

ALT-B4 is Alteogen's proprietary human recombinant hyaluronidase enzyme developed utilizing Hybrozyme™ technology. ALT-B4 can enable the large volume subcutaneous administration of drugs that are typically administered as an IV infusion. ALT-B4 does this by temporarily hydrolyzing hyaluronan in the extracellular matrix.

About Alteogen Inc.

Alteogen Inc. is a South Korea-based biopharmaceutical company that focuses on the development and commercialization of novel biologics such as Antibody-Drug Conjugates (ADCs), biobetters, and biosimilars. Alteogen's portfolio includes clinical-stage long-acting therapeutic proteins and next-generation ADCs, developed by its proprietary NexP™-fusion and NexMab™ platform technology, respectively. It also developed a proprietary recombinant human hyaluronidase enzyme utilizing Hybrozyme™ technology, which enables the large volume subcutaneous administration of drugs that are typically administered as an IV infusion. The company was founded in 2008 and listed in KOSDAQ (196170.KQ).

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com.

Contacts

US: Vivek Shenoy, Ph.D., MBA
Chief Business Officer
Phone: +1 805 570 8998
E-mail: vivek_shenoy@alteogen.com

ROW: Tae-Yon Chun, Ph.D., J.D.
EVP/Corporate Alliance Officer
Phone: +82 042 867 8861
E-mail: alliance@alteogen.com

 

Cision View original content:https://www.prnewswire.com/news-releases/alteogen-enters-into-an-exclusive-license-agreement-to-develop-and-commercialize-subcutaneous-enhertu-enabled-by-alteogens-hybrozyme-technology-302300671.html

SOURCE Alteogen Inc.

FAQ

What is the purpose of Alteogen's license agreement with Daiichi Sankyo?

The agreement allows Daiichi Sankyo to use Alteogen's ALT-B4 Hybrozyme™ Technology to develop and commercialize a subcutaneous version of ENHERTU®.

What are the financial terms of Alteogen's agreement with Daiichi Sankyo?

Alteogen will receive an upfront payment, milestone payments for development and regulatory achievements, and tiered royalties on product sales.

What is Alteogen's role in the ENHERTU® subcutaneous development?

Alteogen will be responsible for the clinical and commercial supply of ALT-B4 to Daiichi Sankyo.

DAIICHI SANKYO S/ADR

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