Daewoong strikes $92 million deal with Zydus to develop anticancer injection in US
Daewoong Pharmaceutical said Monday that it has signed an exclusive license agreement with UAE-based Zydus Worldwide DMCC, a wholly owned subsidiary of Zydus Lifesciences headquartered in India, to co-develop and commercialize leuprolide acetate for depot suspension, DWJ108U, in the U.S.
The contract period is seven years after the first sale, valued at $92.4 million.
DWJ108U is manufactured in the same way as AbbVie's original drug, Lupron Depot. If DWJ108U is approved as a generic drug for Lupron Depot in the U.S., it will cover four indications at once: prostate cancer, premenopausal breast cancer, endometriosis, and uterine fibroids.
Zydus Worldwide DMCC, based in Dubai, is a global pharmaceutical group with 36 manufacturing sites worldwide.
Under the terms of the agreement, Daewoong will be responsible for the pre-clinical studies, production, and supply of the product and Zydus will assume full responsibility for the clinical development and commercialization of the product in the U.S. market.
Daewoong, utilizing its proprietary technology, will produce DWJ108U within its manufacturing facilities located in Osong, North Chungcheong Province. The exclusive licensing 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.
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.
According to IQVIA, a clinical research firm, leuprolide acetate for depot suspension had annual sales of approximately $ 671 million in the U.S. with a growth rate of 10 percent in 2023.
By combining the unique strengths and expertise of both companies to develop and commercialize DWJ108U, Zydus and Daewoong are set to make a positive impact in the healthcare industry, ensuring accessibility, affordability, and enhanced patient empowerment.
“Given the complexity, complex generic drug products like DWJ108U do not exist to date and we aim to be the first company to manufacture the generic version of this complex, long-acting injectable Lupron depot product,” said Jeon Seng-ho, CEO of Daewoong Pharmaceutical. “We are delighted to enter into this exclusive licensing agreement with Zydus as part of our plan to develop and commercialize long-acting injectable leuprolide acetate.”
Sharvil Patel, Managing Director of Zydus Lifesciences, said, “Enabling access to affordable generic versions for patients in the U.S. has been our ongoing commitment."
It marks a significant milestone, and the company is pleased to collaborate with Daewoong on developing a generic version of Lupron Depot, providing patients with access to essential therapy, he added.