Zydus and Daewoong Pharma Sign Deal To Develop Leuprolide Acetate

Zydus Lifesciences Ltd signed a licensing agreement with Daewoong Pharmaceutical Co Ltd of South Korea to co-develop and commercialize a generic version of Leuprolide Acetate for depot suspension, which is used to treat advanced prostatic cancer, endometriosis, and uterine leiomyomata (fibroids). Zydus Worldwide DMCC, a wholly-owned subsidiary of Zydus Lifesciences, and Daewoong Pharmaceutical Co Ltd have entered into an exclusive licensing agreement to co-develop and commercialize Leuprolide Acetate for depot solution in six dosage strengths for the 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, it added, as per economic times.

"Daewoong, utilising its proprietary technology, will produce Leuprolide Acetate for depot suspension in its manufacturing facilities located in Osong, South Korea," the filing said.

The exclusive agreement also includes development, regulatory, and commercialization milestone payments contingent on success. This arrangement also includes a profit share on future sales between the two companies, according to Zydus, without providing financial details.

Commenting on the agreement, Zydus Lifesciences Managing Director Sharvil Patel said, "This is an important milestone and we are happy to work with Daewoong for the generic version of Lupron Depot, empowering patients with access to a critical therapy. This is yet another step to strengthen Zydus' complex injectable portfolio."

Daewoong Pharmaceutical CEO Sengho Jeon 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, long-acting injectable Lupron Depot product."