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Zydus & Daewoong Strike Exclusive Deal to Co-Develop Leuprolide Acetate

Written by : Nikita Saha

December 12, 2023

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The exclusive agreement gives Zydus the responsibility for clinical development and commercialising Leuprodite Acetate in the US market. Further, Daewoong will take charge of the pre-clinical studies, production and supply of the product.

Zydus Worldwide DMCC, a wholly owned subsidiary of Zydus Lifesciences Ltd and Daewoong Pharmaceutical Co, Ltd have entered into an exclusive licencing agreement to co-develop and commercialise Leuprolide Acetate for depot suspension in six dosage strengths for the US market.

The exclusive agreement gives Zydus the responsibility for clinical development and commercialising Leuprodite Acetate in the US market. Further, Daewoong will take charge of the pre-clinical studies, production and supply of the product.

Additionally, Daewoong, utilising 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 commercialisation milestone payments based on the successful outcome. Additionally, this agreement also includes a profit share on future sales between the two companies.

This strategic move aims to ensure accessibility, affordability and enhanced patient empowerment in the healthcare industry.

Commenting on the same, Dr Sharvil Patel, MD, Zydus Lifesciences Ltd, 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 a generic version of Lupron Depot, empowering patients with access to critical therapy. This is yet another step to strengthen the Zydus’ complex injectable portfolio.”

Talking about the drug, Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH) and possesses greater potency than the natural hormone. It is used in various treatments such as to treat symptoms associated with advanced prostate cancer. It is also used with other medications to treat anaemia caused by uterine fibroids.

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, formerly known as Cadila Healthcare Limited, is an Indian multinational pharmaceutical company founded in 1952 by Ramanbhai Patel. The company is thoroughly engaged in producing formulations for active pharmaceutical ingredients, animal healthcare products, and wellness products.

Days back, Zydus’ Methylene Blue Injection gained the USFDA nod. The approval was granted to Methylene Blue Injection in 10mg/2ml and 50mg/5ml formulations, allowing it to market in the US. The novel injection is an oxidation-reduction agent indicated for treating pediatric and adult patients with acquired methemoglobinemia.


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