Zydus and Daewoong Pharmaceutical to co-develop and commercialise Leuprolide Acetate, announce exclusive licensing agreement

Zydus Worldwide DMCC and South Korea-based Daewoong Pharmaceutical on Monday (December 11, 2023) announced that they have entered an exclusive licensing agreement to co-develop and commercialise Leuprolide Acetate for Depot Suspension in six dosage strengths for the US market.

The announcement was made through an exchange filing.

As per 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.

Managing Director of Zydus Lifesciences Ltd., Dr. Sharvil Patel 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.”

Leuprolide Acetate Depot Suspension: Multifaceted treatment sees robust US sales growth

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 percent, according to IQVIA data MAT Oct-2023.

(The article is published under a mutual content partnership arrangement between The Free Press Journal and Connected to India)