Daewoong Pharmaceutical Challenges US Cancer Drug Market... Developing Generic Prostate Cancer Treatment

Prostate Cancer Treatment 'Lupron Depot'
Collaboration with India's Zydus... Contract Amount 120 Billion KRW

Daewoong Pharmaceutical is entering the U.S. oncology drug market by partnering with global pharmaceutical company Zydus.

Exterior view of Daewoong Pharmaceutical headquarters. [Photo by Daewoong Pharmaceutical]

On the 11th, Daewoong Pharmaceutical announced that it has signed a joint development, technology licensing, and product supply agreement with Zydus Worldwide DMCC (Zydus) for the U.S. clinical development and commercialization rights of the anticancer drug 'DWJ108U (active ingredient leuprorelin acetate)' depot (extended-release) injection.

DWJ108U, developed jointly by Daewoong Pharmaceutical and Zydus, is the first generic version of the prostate cancer treatment 'Lupron Depot' in the U.S. Lupron Depot, developed by Japan's Takeda Pharmaceutical, was launched in the U.S. in 1989, but due to the complexity of developing the same formulation, no generic drug has yet been approved (ANDA) in the U.S. market.

The U.S. market size for leuprorelin acetate as the main ingredient reaches approximately 1.6 trillion KRW, with the original Lupron Depot holding a monopoly.

Daewoong Pharmaceutical's DWJ108U uses an emulsion principle to encapsulate the drug in fine polymer particles, which is the same method as the original product Lupron Depot. If DWJ108U is approved as a generic of Lupron Depot in the U.S., it will receive indications for four conditions at once: ▲prostate cancer ▲pre-menopausal breast cancer ▲endometriosis ▲uterine fibroids.

Through this agreement, Daewoong Pharmaceutical will be responsible for non-clinical studies, manufacturing, and supply to launch DWJ108U as the first generic in the U.S. market. Zydus will conduct clinical development and commercialization. The contract amount is approximately 122.2 billion KRW, with a contract period of up to 7 years after the first sale. In addition to the contract amount, Daewoong Pharmaceutical will receive a significant share of the profits generated locally each year.

Jeon Seung-ho, CEO of Daewoong Pharmaceutical, said, "Although Lupron Depot has been on the U.S. market for 35 years, no generic product has been developed due to the difficulty of development. We will complete the clinical trials of DWJ108U, the first generic of Lupron Depot, together with Zydus, which has a strong presence in the U.S. market, and successfully establish ourselves in the U.S. oncology drug market."

Shavil Patel, CEO of Zydus, said, "This agreement is another step to strengthen Zydus's injectable portfolio, and it is significant that DWJ108U can reach patients more easily in the U.S. with a competitive price compared to the original drug. We look forward to a successful launch in the U.S. through close cooperation with Daewoong Pharmaceutical."

Meanwhile, the Zydus Group, to which Zydus belongs, is a global pharmaceutical group headquartered in Ahmedabad, India, with 36 manufacturing plants worldwide. The Zydus Group has received more than 350 ANDAs in the U.S. alone. Notably, Zydus ranked 5th in the U.S. generic prescription drug industry in 2022. Its annual sales in the U.S. reach approximately 1.2 trillion KRW, and total global sales amount to about 2.7 trillion KRW.

This content was produced with the assistance of AI translation services.