Zydus, Daewoong collaborate to co-develop, market Leuprolide Acetate

Zydus Worldwide DMCC, a wholly-owned subsidiary of Zydus Lifesciences Ltd and Daewoong Pharmaceutical Co Ltd, has entered into a licensing agreement to co-develop and commercialise Leuprolide Acetate for Depot Suspension in six dosage strengths for the United States (US) market, the company in a regulatory filing with the BSE.

The terms of the agreement will result in Zydus assuming full responsibility for the clinical development and commercialisation in the US market. Daewoong, on the other hand, will be responsible for the pre-clinical studies, production, and supply of the product.

The company said that Daewoong will leverage its proprietary technology to produce Leuprolide Acetate for Depot Suspension in its manufacturing facilities located in Osong, South Korea. The agreement between the two companies also includes a profit share on future sales, the company said in its filing.

Talking about the development, the Managing Director of Zydus Lifesciences Ltd, 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 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.”

CEO of Daewoong Pharmaceutical said, “Given the complexity, complex generic drug products like Lupron Depot do not exist to date and we aim to be the first company to manufacture the generic version of this complex, long-acting injectable Lupron Depot product.”