Oscotec, the original developer of Lazertinib, the active ingredient in the anticancer drug Leclaza, succeeded in licensing out to the French pharmaceutical company Sanofi an Alzheimer's disease drug candidate co-developed with ADEL. Long seen as having a "Leclaza-only" pipeline, Oscotec plans to use this deal as a springboard to push additional licensing of three or more candidates by 2030.
Chief Executive Yoon Tae-young of Oscotec said at a technology briefing held on the 18th at the Korea Institute of Financial Investment in Yeouido, Seoul, "This Sanofi licensing is not the end but the beginning," adding, "We expect to license out up to three to four more candidates by 2030."
Earlier, ADEL said on the 16th that it had licensed out "ADEL-Y01," an Alzheimer's disease drug candidate co-developed with Oscotec, to the French pharmaceutical company Sanofi. The deal is worth up to 1.53 trillion won. Revenue including milestones (running royalties) and royalties (license fees) will be split 53% for ADEL and 47% for Oscotec. Accordingly, of the 118 billion won upfront payment, Oscotec will receive about 55 billion won.
Talks on this licensing deal moved into high gear after the JPMorgan Healthcare Conference (JPM) in San Francisco early this year. Yoon said, "There was consensus that neither ADEL nor Oscotec had the capacity to carry Alzheimer's through phase 2 on our own," adding, "Our strategy of aiming for licensing before entering phase 2 has now materialized." He added, "We plan to reinvest the funds secured this time back into research and development (R&D)."
He also explained why the contracting party was set as ADEL alone. Yoon said, "The patent and early development of ADEL-Y01 began at ADEL, and global pharma companies generally avoid three-party contracts," adding, "Sanofi requested a bilateral deal, and under the existing division of roles, ADEL became the contracting party." He said the 53-to-47 revenue split reflects this structure.
Market reaction was mixed. On the day news broke of the 1 trillion won-level technology export, Oscotec shares closed at 57,100 won, down 6.58% from the previous day. The market sees the exclusion of Oscotec as the contracting party under the deal structure, and the possibility that the next licensing could take time, as weighing on investor sentiment.
The company says that considering ADEL-Y01's technological competitiveness and clinical progress, the significance of this licensing should be evaluated over the medium to long term.
Yoon said, "There is a hypothesis that the key factor directly damaging neurons in the progression of Alzheimer's is the tau aggregate," adding, "ADEL-Y01 strongly inhibited the spread of tau aggregation to other neurons, and this was the key evidence that persuaded Sanofi."
ADEL-Y01 is a monoclonal antibody that, among tau proteins identified as a major cause of Alzheimer's disease, does not act on normal tau but selectively targets only the "acetylated tau (acK280)" that accumulates in the brain and causes toxicity. A global phase 1 trial is underway.
Yoon said, "It is difficult to make a definitive market forecast depending on the results of phase 2 and 3 Alzheimer's trials," but added, "Assuming a 2037 launch, we conservatively expect at least an 8 trillion won market, and depending on the scenario, it could be 30 trillion won, up to a maximum of 45 trillion won."
ADEL led the early development of ADEL-Y01. ADEL handled the entire process from target discovery to candidate identification, efficacy validation, nonclinical studies, and clinical material production. Oscotec then joined the joint research and development in 2020. ADEL took on chemistry, manufacturing and controls (CMC) and business development, while Oscotec handled studies for investigational new drug (IND) approval, such as toxicity and pharmacokinetics (PK).
Yoon also laid out the future pipeline strategy. Oscotec will halt trials of the autoimmune disease candidate "cevidoplenib" and the solid tumor candidate "denpibonitinib," and seek external licensing by next year. Instead, it will focus its research capabilities on "OCT-598," a compound introduced from Kanaph Therapeutics to block anticancer drug resistance, and "OCT-648," which targets fibrosis. OCT-598 has entered clinical trials, with the first patient dosed on the day, and OCT-648 is at the preclinical stage.
Yoon said, "We will boldly streamline pipelines that do not fit the strategy and secure at least two or more new candidates," adding, "We are also reviewing next-generation technologies, new modalities, and new businesses centered on the anticancer resistance field."
Regarding subsidiary Genosco, he said, "Regardless of the outcome of the recent extraordinary shareholders meeting, we will move to make it a 100% subsidiary," adding, "We will announce specific measures for synergy with Genosco early next year."