Leuprolide acetate for depot suspension is a gonadotropin releasing hormone (GnRH) aganist, 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.

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 Acetate 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.

Dr. Sharvil Patel, managing director, Zydus Lifesciences, said, “Enabling access to affordable generic versions for patients in the US has been our ongoing commitment. This is an important milestone and we are happy to work with Daewoong for generic version of Lupron Depot, empowering patients with the access to a critical therapy. This is yet another step to strengthen the Zydus’ complex injectable portfolio.”

Sengho Jeon, chief executive officer, Daewoong Pharmaceutical, said, “Given the complexity, complex generic drug products like Lupron Depot do not exist to date and we aim to be the first company in manufacturing the generic version of this complex, longacting injectable Lupron Depot product,” additionally “We are delighted to enter into this exclusive licensing agreement with Zydus as part of our plan to develop and commercialize long-acting injectable of Leuprolide Acetate.”

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company consolidated net profit surged 53.2% to Rs 800.7 crore in Q2 FY24 as compared with Rs 522.5 crore posted in Q2 FY23. Revenue from operations rose 9.1% YoY to Rs 4,368.8 crore during the quarter ended 30 September 2023.

Shares of Zydus Lifesciences rose 0.17% to Rs 639.65 on the BSE.