November 25, 2024

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Daewoong Pharmaceutical's headquarters in Seoul (Daewoong Pharmaceutical)

Daewoong Pharmaceutical announced Monday that the company has signed an exclusive licensing agreement with Zydus Worldwide DMCC to co-develop leuprolide acetate for depot suspension, DWJ108U, a generic of AbbVie’s prostate cancer, endometriosis and uterine fibroids treatment, Lupron Depot.

Based in the UAE, Zydus Worldwide DMCC is a wholly-owned subsidiary of Zydus Lifesciences, which was also formerly known as Cadila Healthcare Limited.

“Together with Zydus, Daewoong Pharmaceutical will aim to develop and commercialize a generic of AbbVie’s Lupron Depot in the US market,” an official from Daewoong Pharmaceutical said.

The value of the licensing contract between the two companies is estimated at around $92.4 million, including $25.5 million in a commercialization milestone payment, and an additional $66.9 million upon the new treatment's potential US launch.

The total amount is equivalent to 9.6 percent of Daewoong’s annual sales last year.

According to clinical research firm IQVIA’s data, leuprolide acetate for depot suspension had annual sales of approximately $671 million in the US with a growth rate of 10 percent in 2023.

Under the agreement, Daewoong will be responsible for the preclinical studies, production and supply of DWJ108U. The company said it will produce DWJ108U at its manufacturing facilities located in Osong, North Chungcheong Province.

Zydus, on the other hand, will take full charge of clinical trials and commercialization of DWJ108U in the US market.

“Given the complexity, complex generic drug products like Lupron Depot 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,” Daewoong Pharmaceutical CEO Jeon Seng-ho said.

Managing Director of Zydus Lifesciences Sharvil Patel also 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 the generic version of Lupron Depot.”

By Shim Woo-hyun  (ws@heraldcorp.com)