Daewoong attempts at first Lupron Depot generic in the US

Targets the KRW 1.6 trillion mkt

Signed a co-development and commercialization agreement with Zydus…KRW 12.2 bil deal

Daewoong Pharmaceutical is seeking to enter the U.S.

 

anticancer market with the global pharmaceutical company, Zydus Worldwide DMCC.

 

Daewoong Pharmaceutical announced on the 11th that it had signed a licensing agreement with Zydus Worldwide DMCC.

 

to co-develop and commercialize the anticancer drug DWJ108U Depot suspension injection.

 

The value of the agreement is estimated to be near KRW 12.22 billion at most.

 

This includes an upfront payment of $9.24 million (KRW 12.2 billion), development and commercialization milestones of $2.55 million (KRW 3.4 billion), and an additional supply agreement worth $66.89 million (KRW 88.5 billion).

 

Under the agreement, Zydus will be assuming full responsibility for the joint clinical development and commercialization of Daewoong’s Depo injection product in the US market.

 

The contract term is seven years after launch in the US and may be subject to change depending on the drug’s release date in the US.

 

DWJ108U, which is being jointly developed by Daewoong Pharmaceutical and Zydus, is the first generic of ‘Lupron Depot’ to be introduced to the US.

 

Lupron Depot was released in the US in 1898, but due to the difficulty of developing a generic version of the drug, no generic product has ever passed the Abbreviated New Drug Application (ANDA) process in the U.S.

 

market.

 

The US leuprolide acetate market is valued at approximately $1.6 trillion, with Lupron Depot holding a dominant position in the market.

 

Daewoong Pharmaceutical's DWJ108U utilizes the emulsion principle to encapsulate the drug in microscopic polymer particles, which is the same manufacturing method as the original Lupron Depot.

 

If DWJ108U is approved as a generic for Lupron Depot in the United States, it will be approved for 4 indications at once - prostate cancer, premenopausal breast cancer, endometriosis, and uterine fibroids.

 

Daewoong Pharmaceutical will be responsible for the pre-clinical studies, production, and supply of the product, with Zydus pursuing its clinical development and commercialization in the US market.

 

Seng-Ho Jeon, CEO of Daewoong Pharmaceutical, said, “Although Lupron Depot has been in the US market for 35 years, no single generic product to date has been introduced to date due to difficulties in its development.

 

With Zydus, who owns a strong presence in the US market, we plan to complete the clinical trials of DWJ108U, the first generic version of Lupron Depo, and successfully introduce it to the US anticancer drug market." Sharvil Patel, Managing Director of Zydus Lifesciences, said, "The agreement is another step towards strengthening our injectable portfolio, and is an important step towards enabling access to affordable generic versions for patients in the US.

 

This is an important milestone and we are happy to work with Daewoong for a generic version of Lupron Depot, and wish for its successful launch in the US.” Zydus Worldwide DMC is a wholly-owned subsidiary of Zydus Lifesciences, a global pharmaceutical group headquartered in Ahmedabad, India.

 

The company owns 36 manufacturing sites worldwide.

 

Fourteen of these facilities are US cGMP certified.

 

The company is an expert in regulatory approvals, with more than 350 ANDAs approved in the U.S.

 

alone.

 

Last year, Zydus sales in the US market were approximately $1.2 trillion and total global sales were approximately $2.7 trillion.