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Daewoong, Zydus Sign $92M Agreement to Produce Generic Treatment in US

Zydus and Daewoong will produce and market a generic of Lupron Depot drug in the U.S.

Daewoong Pharmaceuticals struck a deal with Zydus Worldwide DMCC to co-develop anti-cancer injectables in the United States. For this tie-up, the companies signed an agreement worth $92 million.

Korea’s Daewoong and UAE-based Zydus Group aim to market Leuprolide acetate through their licensing deal for the development of a generic of Lupron Depot drug, a leuprolide acetate for depot suspension, that is used for the treatment of advanced prostate cancer, uterine fibroids, and endometriosis. As per The Korea Herald, the former announced its exclusive licensing contract with the latter on Monday, Dec. 11.

Terms of the Deal: Division of Responsibilities

It was stipulated in the agreement that Daewoong would be in charge of preclinical research, studies, production, and supply of the generic called the DWJ108U. The Korean firm shared that it will manufacture the drug at its production plant in Osong, located in North Chungcheong Province.

On the other hand, Zydus will be responsible for all clinical trials and the commercialization of the DWJ108U in the U.S. “Together with Zydus, Daewoong Pharmaceutical will aim to develop and commercialize a generic of AbbVie’s Lupron Depot in the U.S. market,” an official of the Korean pharma company said in a statement.

Contract Period and Payment Agreement

Korea BioMedical Review reported that Daewoong and Zydus agreed to work together for seven years following the first sale. The total value of the licensing deal is about $92.4 million, which will be paid in various forms, including $25.5 million in a commercialization milestone payment and the remaining $66.9 million to be settled soon after the drug’s possible launch in the U.S. market.

Jeon Seng Ho, Daewoong Pharmaceutical’s chief executive officer, said, “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.”

Lastly, Zydus Lifesciences’ managing director, Sharvil Patel, added, “This is an important milestone and we are happy to work with Daewoong for the generic version of Lupron Depot.”

Photo by: Zydus Life Media Kit

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