{"id":11891,"date":"2024-11-09T15:04:08","date_gmt":"2024-11-09T07:04:08","guid":{"rendered":"https:\/\/flcube.com\/?p=11891"},"modified":"2024-11-09T15:04:11","modified_gmt":"2024-11-09T07:04:11","slug":"daiichi-sankyo-and-alteogen-sign-300-million-deal-to-develop-subcutaneous-enhertu","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=11891","title":{"rendered":"Daiichi Sankyo and Alteogen Sign $300 Million Deal to Develop Subcutaneous Enhertu"},"content":{"rendered":"\n

Daiichi Sankyo (TYO: 4568<\/a>), a leading Japanese pharmaceutical company, has entered into a potentially $300 million agreement with South Korean biotechnology firm Alteogen to develop a subcutaneous injection version of its cancer drug Enhertu, which is also in collaboration with AstraZeneca. This innovative step aims to enhance patient accessibility and convenience in administering the drug.<\/p>\n\n\n\n

Financial Terms and Milestones<\/strong>
Under the agreement, Alteogen will receive an upfront payment of $20 million, with an additional $280 million to be paid by Daiichi Sankyo upon achieving certain sales targets following the launch of the new formulation of Enhertu (trastuzumab deruxtecan). The successful development of this subcutaneous version could mark a significant advancement, potentially making Enhertu the first antibody-drug conjugate (ADC) to be administered via subcutaneous injection, which would be a substantial benefit for patients by allowing administration outside of clinical settings, possibly even at home with auto-injectors.<\/p>\n\n\n\n

Development Approach and Technology<\/strong>
Alteogen will utilize its Hybrozyme platform, including recombinant human hyaluronidase ALT-B4, to develop the new version of Enhertu. This enzyme temporarily hydrolyzes hyaluronic acid in the subcutaneous layer of the skin’s extracellular matrix, allowing for the delivery of a higher volume of drug substance and improving dispersion and absorption.<\/p>\n\n\n\n

Industry Precedent and Partnerships<\/strong>
This approach is well-established, pioneered by Halozyme and its Enhanze technology, which has been utilized in several marketed products, including Roche’s Herceptin Hylecta (trastuzumab\/hyaluronidase) and Phesgo (pertuzumab\/trastuzumab\/hyaluronidase). Alteogen also signed an agreement with Sandoz last year to develop a Hybrozyme-based version of an undisclosed biosimilar and has the option for two additional projects. Furthermore, Alteogen is collaborating with Merck to develop a subcutaneous version of its blockbuster cancer immunotherapy, Keytruda. While the financial terms of the Sandoz agreement were not disclosed, Merck paid Alteogen $20 million upfront with potential milestone payments reaching up to $432 million.<\/p>\n\n\n\n

Enhertu’s Growing Success<\/strong>
Enhertu is rapidly becoming a key growth product for both Daiichi Sankyo and AstraZeneca (AZ, NASDAQ: AZN<\/a>), with sales reaching $1.77 billion in the first half of the year, up from $1.16 billion in the same period in 2023. This rapid growth is attributed to the expansion of indications for breast cancer, gastric cancer, and non-small cell lung cancer (NSCLC), as well as the tissueagnostic application for HER2-positive solid tumors.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

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