Daewoong Pharmaceutical(CEO Seng-ho Jeon and Chang-jae Lee) has secured an exclusive licensing agreement with CS Pharmaceuticals (“CSP”), a UK based multinational company focused on the development and commercialization of rare disease and ophthalmology products in China, for a first-in-class PRS inhibitor Bersiporocin in Greater China region, including mainland China, Hong Kong, Taiwan, and Macau. Under this agreement, CSP will in-license Bersiporocin for Idiopathic Pulmonary Fibrosis (IPF) and potentially other fibrotic indications for a total consideration of up to $336M, including up to $76M in Upfront and Development milestone payments and double-digit royalties on Net Sales.
Under the terms of the agreement, Daewoong will grant CSP exclusive development and commercialization rights to Bersiporocin in IPF and other respiratory indications. Bersiporocin is a first-in-class antifibrotic agent that is being developed by Daewoong. CSP is focused on licensing Chinese commercialization rights to international rare disease and ophthalmology medicines. The company, with its headquarters in London and offices in Beijing and Shanghai, offers dedicated regulatory, market access, medical and commercial expertise, in addition to international-standard compliance and legal capabilities. The team has an impressive track record of success in China, providing partners with significant experience in this fast-growing market. With its dedicated commercialization platform, CSP is rapidly becoming a ‘go-to’ trusted licensing partner, expanding its portfolio of innovative rare disease and ophthalmology assets while making business easier for companies wishing to develop and commercialize their products in China.
Idiopathic Pulmonary Fibrosis is a rare, progressive lung disease in which thickening and hardening of lung tissues cause decline of lung function. It is a life-threatening disease with a 5-year survival rate less than 50% at diagnosis. There are available treatments for IPF, Ofev from Boeheringer Ingelheim and Esbriet from Roche, yet there is still tremendous unmet medical needs as these treatments have limited therapeutic benefits to patients.
Bersiporocin has been granted US FDA Orphan Drug Designation as well as FastTrack Designation for IPF. In 2022, Daewoong initiated a multi-regional Phase 2 clinical trial for IPF. This study is being supported by Korea Drug Development Fund.
CEO Seng-ho Jeon of Daewoong Pharmaceutical stated, “We are pleased announce the exclusive licensing agreement with CS Pharmaceuticals to accelerate global development of Bersiporocin” and added, “This will be the stepping stone towards becoming a game changer in the global development of Bersiporocin for IPF and other life-threatening diseases.”
“Securing the Chinese commercial rights to Bersiporocin with the initial focus in IPF marks another milestone for CSP, as we continue to expand our portfolio of innovative products in China. IPF is a priority rare disease in China which a huge unmet need. It is currently estimated that nearly 50% of IPF patients in China will die within 2 to 3 years after diagnosis commented Darren Mercer, CS Pharmaceuticals’ CEO. “Completing this transaction further strengthens our rare disease portfolio as we continue to focus on bringing innovative rare disease and ophthalmology medicines to Chinese patients, to address the significant unmet medical needs in this rapidly growing market. We are eagerly awaiting the results from the phase 2 study in IPF due in H1 2024”.