Zydus, Daewoong sign licensing pact to develop, market Leuprolide long-acting injectable in US

Zydus Worldwide DMCC, a wholly owned subsidiary of Zydus Lifesciences and Daewoong Pharmaceutical Co announced that they have entered into an exclusive licensing agreement to co-develop and commercialise 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 commercialisation in the US market, and Daewoong will be responsible for the pre-clinical studies, production and supply of the product. Daewoong, utilising its proprietary technology, will produce Leuprolide Acetate for Depot Suspension in its manufacturing facilities located in Osong, South Korea. The exclusive agreement also includes development, regulatory, and commercialisation milestone payments based on the successful outcome. Additionally, this agreement also includes a profit share on future sales between the two companies.

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 acetate for depot suspension had annual sales of approximately $671 million in the US with a growth rate of 10 per cent, according to IQVIA data MAT Oct-2023.