Daiichi Sankyo Secures Non-Exclusive License to Ultragenyx’s AAV Manufacturing Platforms to Accelerate Gene Therapy Development

Compiled by Fan Dongdong

Daiichi Sankyo Announces Non-Exclusive Licensing Agreement Worth Nearly $300 Million with Ultragenyx Pharmaceutical to Collaborate on the Development and Manufacturing of Gene Therapy Products

The collaboration agreement reveals that Ultragenyx granted Daiichi Sankyo a non-exclusive license to its HeLa PCL and HEK293 transient transfection manufacturing technology platform for AAV gene therapy products. Boosted by this positive news, Ultragenyx’s stock price closed near $44.50 on Tuesday and rose nearly 7% to $47.42 in early Wednesday trading.

In a press release, Daiichi-Sankyo stated: “Currently, we are conducting discovery research on gene therapy drugs using AAV vectors, which is one of the key channels for sustaining continuous growth after achieving our 2025 Vision. Ultragenyx’s proprietary technology has demonstrated exceptional performance in terms of quality consistency, production efficiency, and scalability.”

In return, Daiichi Sankyo will pay an upfront payment of $175 million and purchase Ultragenyx shares worth a total of $75 million at approximately $60 per share. Upon completion of the technology transfer for the HeLa PCL and HEK293 platforms, Daiichi Sankyo will make an additional payment of $25 million, plus royalties on net sales of products manufactured using these two systems. Furthermore, Daiichi Sankyo is required to cover all expenses incurred by Ultragenyx related to the manufacturing technology transfer.

Emil D. Kakkis, M.D., Chief Executive Officer and President of Ultragenyx, stated, “Our partnership with Daiichi Sankyo further validates the value of Ultragenyx’s gene therapy-related technologies, particularly the HeLa cell line production platform, which we believe is the most promising AAV cell manufacturing system.”

Last December, Daiichi Sankyo achieved its first victory in the field of oncology research. Enhertu, a HER2-targeting antibody-drug conjugate (ADC) developed in collaboration with AstraZeneca, received accelerated approval from the U.S. Food and Drug Administration (FDA) for patients with resected or metastatic HER2-positive breast cancer who have previously received two or more prior anti-HER2 regimens. This innovative ADC leverages Daiichi Sankyo’s DXd ADC technology platform, incorporating multiple technological innovations in the cytotoxic payload and linker components. In March 2019, AstraZeneca and Daiichi Sankyo entered into an immuno-oncology collaboration valued at up to $6.9 billion to jointly develop Enhertu. Under the agreement, AstraZeneca and Daiichi Sankyo co-develop and commercialize Enhertu globally, while Daiichi Sankyo retains exclusive rights to the drug in the Japanese market. Last week, the drug officially received approval from Japan’s Ministry of Health, Labour and Welfare.

References:

1、Daiichi Sankyo inks $200M licensing deal with Ultragenyx to boost gene therapy manufacturing

2、Ultragenyx Enters into Strategic Partnership with Daiichi Sankyo for Gene Therapy Manufacturing Technology

3、Ultragenyx's gene therapy technology finds another interested party