Zydus Worldwide DMCC, a wholly owned subsidiary of Zydus Lifesciences Ltd. and Daewoong Pharmaceutical Co. Ltd. announced that they have entered into an exclusive licensing agreement to co-develop and commercialize Leuprolide Acetate for Depot Suspension (RLD: Lupron Depot, AbbVie) in six dosage strengths for the United States (US) market. Under the terms of the agreement, Zydus will assume full responsibility for the clinical development and commercialization in the US market, and Daewoong will be responsible for the pre-clinical studies, production and supply of the product.

Daewoong, utilizing its proprietary technology, will produce Leuprolide Acetated for Depot Suspension in its manufacturing facilities located in Osong, South Korea. The exclusive agreement also includes development, regulatory, and commercialization milestone payments based on the successful outcome. Additionally, this agreement also includes a profit share on future sales between the two companies.

By combining the unique strengths and expertise of both companies to develop and commercialize Leuprologyide Acetate for Depot suspension, Zydus and Daewoong are set to make a positive impact in the healthcare industry, ensuring accessibility, affordability, and enhanced patient empowerment. Leuprolide acetate for depot suspension is a gonadotropin-releasing hormone (GnRH) agonist, a long-acting injectable product in a kit with a prefilled dual-chamber syringe, used for the treatment of advanced prostatic cancer, endometriosis, and uterine leiomyomata (fibroids) depending on its dosage regime. Leuprolide acetated for depot suspension had annual sales of approximately $671 million in the US with a growth rate of 10%, according to IQVIA data MAT Oct-2023.