Zydus And Daewoong Pharmaceutical Announces Exclusive Licensing Agreement To Co-develop & Commercialize Leuprolide Acetate

Zydus And Daewoong Pharmaceutical Announces Exclusive Licensing Agreement To Co-develop & Commercialize Leuprolide Acetate

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.

FPJ Web DeskUpdated: Monday, December 11, 2023, 10:30 AM IST
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Zydus And Daewoong Pharmaceutical Announce Exclusive Licensing Agreement | Image: Zydus (Representative)

Zydus Worldwide DMCC, a wholly owned subsidiary of Zydus Lifesciences Ltd (including its subsidiaries hereafter referred to as Zydus) and Daewoong Pharmaceutical Co., Ltd. (KRX: 069620.KS), on Monday 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, the company announced through an exchange filing.

Zydus and Daewoong Strike Exclusive Deal for Leuprolide Acetate

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.

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.”

Leuprolide Acetate Depot Suspension: Multifaceted Treatment Sees Robust US Sales Growth

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.

Zydus Lifesciences Ltd shares

The shares of Zydus Lifesciences Ltd on Monday at 10:24 am IST were trading at Rs 641, up by 0.38 percent.

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