Zydus and Daewoong Pharmaceutical announce an exclusive licensing agreement

Ahmedabad, December 11: Zydus Worldwide DMCC, a wholly owned subsidiary of Zydus Lifesciences Ltd and Daewoong Pharmaceutical Co., Ltd. today announced that they have entered into an exclusive licensing agreement to co-develop and commercialize Leuprolide Acetate for Depot Suspension (RLD: Lupron Depot®, AbbVie) in six dosage strengths for the United States (US) market.

Under the terms of the agreement, Zydus will assume full responsibility for the clinical development and commercialization in the US market, and Daewoong will be responsible for the pre-clinical studies, production and supply of the product. Daewoong, utilizing its proprietary technology, will produce Leuprolide Acetate for Depot Suspension in its manufacturing facilities located in Osong, South Korea. The exclusive agreement also includes development, regulatory, and commercialization milestone payments based on the successful outcome. Additionally, this agreement also includes a profit share on future sales between the two companies.

By combining the unique strengths and expertise of both companies to develop and commercialize Leuprolide Acetate for Depot Suspension, Zydus and Daewoong are set to make a positive impact in the healthcare industry, ensuring accessibility, affordability, and enhanced patient empowerment.

Speaking about the development, Managing Director of Zydus Lifesciences Ltd., Dr. Sharvil Patel 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 generic version of Lupron Depot, empowering patients with the access to a critical therapy. This is yet another step to strengthen the Zydus’ complex injectable portfolio.”

“Given the complexity, complex generic drug products like Lupron Depot do not exist to date and we aim to be the first company in manufacturing the generic version of this complex, longacting injectable Lupron Depot product,” said Sengho Jeon, Chief Executive Officer, Daewoong Pharmaceutical. “We are delighted to enter into this exclusive licensing agreement with Zydus as part of our plan to develop and commercialize long-acting injectable of Leuprolide Acetate.”

Leuprolide acetate for depot suspension is a gonadotropin-releasing hormone (GnRH) agonist, a long-acting injectable product in a kit with a prefilled dual-chamber syringe, used for the treatment of advanced prostatic cancer, endometriosis, and uterine leiomyomata (fibroids) depending on its dosage regime. Leuprolide acetate for depot suspension had annual sales of approximately $671 million in the US with a growth rate of 10%, according to IQVIA data MAT Oct-2023.

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