The exclusive agreement includes development, regulatory and commercialisation milestone payments based on the successful outcome
Zydus Lifesciences Ltd on Monday announced a licensing pact with South Korea's Daewoong Pharmaceutical Co Ltd to co-develop and commercialise a generic version of Leuprolide Acetate for depot suspension used to treat advanced prostatic cancer, endometriosis and uterine leiomyomata (fibroids).
Zydus Worldwide DMCC, a wholly-owned subsidiary, and Daewoong Pharmaceutical Co Ltd have entered into an exclusive licensing agreement to co-develop and commercialise Leuprolide Acetate for depot suspension in six dosage strengths for the US market, Zydus Lifesciences said in a regulatory filing.
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, it added.
"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 commercialisation milestone payments based on the successful outcome.
Additionally, this agreement also includes a profit share on future sales between the two companies, Zydus said without elaborating on 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."
Leuprolide Acetate for depot suspension is 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, Zydus said.
Leuprolide Acetate for depot suspension had annual sales of approximately USD 671 million in the US with a growth rate of 10 per cent, the company said, citing IQVIA MAT October 2023 data.