SK Biopharm has signed a licensing agreement and a strategic equity investment agreement with drug developer First Bio Therapeutics, securing global exclusive rights to develop and commercialize a novel drug candidate for Parkinson’s disease.
The licensing agreement consists of an upfront payment of approximately $18,000, development and commercialization milestones of up to approximately $531,000, and sales-based milestones of up to $260 million, bringing the total potential deal value to approximately $315 million.
Following commercialization, SK Biopharm will also pay royalties based on net product sales. Separately, the company is making a strategic investment of approximately $2.2 million in First Bio Therapeutics, establishing a foundation for longer-term collaboration beyond the development of the drug candidate.
The agreement marks the first drug candidate acquisition led by SK Biopharm’s Open Innovation Center (OIC). Through the deal, SK Biopharm is adding a potential disease-modifying therapy (DMT) candidate designed to intervene in the progression of Parkinson’s disease itself, further expanding its central nervous system (CNS) pipeline.
Parkinson’s disease is a neurodegenerative brain disorder in which dopamine-producing neurons progressively deteriorate, leading to declining motor function and other symptoms. Most currently available treatments focus on relieving symptoms, leaving significant unmet medical needs for therapies capable of slowing or altering the underlying progression of the disease.
The licensed candidate is an oral small-molecule Parkinson’s disease treatment designed to simultaneously inhibit Type 2 LRRK2 and c-Abl. Its dual-inhibition mechanism distinguishes it from existing approaches and gives it potential for development as a first-in-class therapy.
The candidate was designed to act on multiple mechanisms believed to play important roles in Parkinson’s disease, including endolysosomal dysfunction and the accumulation of alpha-synuclein. Alpha-synuclein is a protein found in nerve cells, and its abnormal aggregation and accumulation are considered a key pathological feature of Parkinson’s disease.
First Bio is leading research to select a preclinical development candidate. SK Biopharm will review subsequent development activities, including research needed to support an Investigational New Drug (IND) application, based on the progress and results of the research program.
Through the agreement, SK Biopharm plans to accelerate its “East-West Bridge” strategy, which is designed to connect promising drug candidates discovered in Korea and other Asian markets with global opportunities.
The East-West Bridge is SK Biopharm’s open R&D model for identifying promising candidates in Asia, validating their potential during the preclinical and early clinical stages, and flexibly leveraging the company’s own clinical development and commercialization capabilities together with global partnerships.
Donghoon Lee, president and CEO of SK Biopharm, said, “This agreement is a concrete example of our East-West Bridge strategy to connect promising Asian drug candidates with global markets. We plan to enhance the value of these candidates by flexibly leveraging our development capabilities and global partnerships while exploring the potential to develop next-generation DMTs that intervene directly in disease progression.”