Zydus Lifesciences, Daewoong Pharmaceutical forge US market alliance for Leuprolide Acetate

Zydus Worldwide DMCC, a wholly-owned subsidiary of Zydus Lifesciences Ltd., and South Korea’s Daewoong Pharmaceutical Co., Ltd. have entered into a significant exclusive licensing agreement. This collaboration aims to co-develop and commercialize Leuprolide Acetate for Depot Suspension (reference listed drug: Lupron Depot, AbbVie) in six dosage strengths for the United States market.

Shared Responsibilities and Production

Under the terms of the agreement, Zydus will be responsible for clinical development and commercialization in the US market. Daewoong Pharmaceutical, leveraging its proprietary technology, will handle pre-clinical studies, production, and supply of the product. The production of Leuprolide Acetate for Depot Suspension will take place in Daewoong’s manufacturing facilities located in Osong, South Korea.

Milestones and Profit Sharing

This exclusive agreement encompasses development, regulatory, and commercialization milestone payments based on successful outcomes. Additionally, it includes a profit-sharing arrangement on future sales between Zydus and Daewoong, marking a significant step in their collaborative journey.

Exclusive Licensing Agreement: Zydus Lifesciences and Daewoong Collaborate for Leuprolide Acetate

Impact on Healthcare Industry

This partnership between Zydus and Daewoong is poised to make a positive impact in the healthcare industry, focusing on accessibility, affordability, and enhanced patient empowerment. Managing Director of Zydus Lifesciences Ltd., Dr. Sharvil Patel, commented, “This is an important milestone and we are happy to work with Daewoong for the generic version of Lupron Depot, empowering patients with access to critical therapy and strengthening Zydus’ complex injectable portfolio.”

Addressing Complex Medication Needs

Daewoong Pharmaceutical’s CEO, Sengho Jeon, emphasized the complexity of such drug products and the aim to be the first company in manufacturing the generic version of this long-acting injectable Lupron Depot product.

Market Significance

Leuprolide acetate for depot suspension, a gonadotropin-releasing hormone (GnRH) agonist, is used for treating advanced prostatic cancer, endometriosis, and uterine leiomyomata (fibroids) depending on the dosage regime. According to IQVIA data MAT Oct-2023, it had annual sales of approximately $671 million in the US, with a growth rate of 10%

The partnership between Zydus Lifesciences and Daewoong Pharmaceutical marks a notable development in the pharmaceutical industry, particularly in the complex injectable market. It demonstrates their commitment to bringing advanced, affordable healthcare solutions to the US market.