South Korea-based Daewoong Pharmaceutical has entered into an exclusive licensing agreement with UK-based CS Pharmaceuticals (CSP) for its first-in-class PRS inhibitor, bersiporocin. Under the agreement, CSP will hold exclusive development and commercial rights to the drug in Greater China, including mainland China, Hong Kong, Taiwan, and Macau. The deal covers indications for Idiopathic Pulmonary Fibrosis (IPF) and other respiratory diseases.
Deal Details and Financial Commitments
CSP has committed to a total deal value of USD 336 million, including up to USD 76 million in upfront and development milestone payments to Daewoong. Additionally, Daewoong will receive double-digit royalties on net sales. This partnership underscores CSP’s focus on rare disease and ophthalmology products in China, while leveraging Daewoong’s innovative pipeline.
IPF: Unmet Medical Needs and Current Treatments
Idiopathic Pulmonary Fibrosis (IPF) is a rare, progressive lung disease characterized by the thickening and hardening of lung tissues, leading to a decline in lung function. With a five-year survival rate of less than 50% at diagnosis, IPF remains a life-threatening condition. Current treatments, including Ofev from Boehringer Ingelheim and Esbriet from Roche, offer limited therapeutic benefits, highlighting significant unmet medical needs.
Bersiporocin Development and Regulatory Milestones
Bersiporocin has been granted Orphan Drug Designation and Fast Track Designation by the US FDA for the treatment of IPF. In 2022, Daewoong initiated a multi-regional Phase II clinical trial for bersiporocin, supported by the Korea Drug Development Fund. The study is expected to conclude in the first half of 2024. CSP’s involvement in the Greater China region will further advance the drug’s development and commercial potential in addressing IPF and other respiratory diseases.-Fineline Info & Tech