Zydus and Daewoong Forge Exclusive Deal to Develop and Commercialize Leuprolide Acetate in the US

11 Dec 2023 , 01:37 PM

Zydus Worldwide DMCC and Daewoong Pharmaceutical Co Ltd sign an exclusive licensing agreement for Leuprolide Acetate in the US market. Zydus to take charge of clinical development and commercialization in the US, while Daewoong handles pre-clinical studies, production, and supply.

Daewoong will produce Leuprolide Acetate in its South Korea facilities using proprietary technology. The agreement includes milestone payments based on successful outcomes in development, regulatory processes, and commercialization.

Profit-sharing on future sales also part of the exclusive agreement between Zydus and Daewoong.

Zydus aims to strengthen its complex injectable portfolio with the generic version of Lupron Depot, according to Managing Director Sharvil Patel.

Daewoong Pharmaceutical seeks to be the first to manufacture the generic version of the complex, long-acting injectable Lupron Depot product.

Leuprolide Acetate for depot suspension is used for treating advanced prostatic cancer, endometriosis, and uterine leiomyomata.

Annual sales of Leuprolide Acetate for depot suspension in the US reached approximately USD 671 million with a growth rate of 10%, as per IQVIA MAT October 2023 data.

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