SK BIOPHARMACEUTICALS Secures New Parkinson’s Disease Drug Worth 430.8 Billion WonOn the 17th
,SK BIOPHARMACEUTICALS signed an agreement with First BioTherapeutics to secure exclusive global development and commercialization rights for the Parkinson’s disease drug candidate “1ST-104.” The companies also entered into a strategic equity investment agreement under which SK BIOPHARMACEUTICALS will invest 3 billion won in First BioTherapeutics.
The licensing agreement consists of an upfront payment of 2.5 billion won and milestone payments totaling up to 72.5 billion won, tied to specific stages of research, development, and commercialization. These milestone payments will be made upon the achievement of research and development, regulatory approval, and sales targets. Following product launch, an additional payment of up to $260 million (approximately 355.8 billion won) will be made based on net sales. The total value of the agreement, including all these payments, amounts to a maximum of 430.8 billion won.
1ST-104 aims to be a disease-modifying therapy (DMT) that not only temporarily alleviates symptoms but also slows the progression of Parkinson’s disease itself. Parkinson’s disease is a degenerative brain disorder characterized by the gradual loss of dopamine-producing neurons in the brain that control movement, leading to symptoms such as hand tremors, rigidity, and slowed movement.
Currently used Parkinson’s disease treatments primarily focus on replenishing deficient dopamine or enhancing dopamine’s effects. While effective at reducing patients’ motor symptoms, they cannot restore damaged neurons or fundamentally halt the progression of the disease. For this reason, the global pharmaceutical and biotech industries are actively developing treatments that directly target the causes of neuronal damage.
This agreement is also significant in that it marks the beginning of SK BIOPHARMACEUTICALS’ efforts to expand its CNS pipeline not only through in-house R&D but also by acquiring external drug candidates. While SK BIOPHARMACEUTICALS has independently developed the new epilepsy drug “cenobamate” and markets it directly in the U.S., the fact that its revenue is concentrated on a single product has been cited as a challenge. If the Parkinson’s disease candidate is successfully developed, the company will be able to expand its business scope from its current focus on epilepsy to include degenerative brain diseases.
Orum Therapeutics, Inc.: Development of Blood Cancer Drug Transferred to BMS HaltedOn the same day, Orum Therapeutics, Inc. announced in a regulatory filing that BMS had halted clinical development of the blood cancer treatment candidate “BMS-986497 (ORM-6151).” The reason for the clinical halt was not disclosed. After reviewing data from Phase 1 clinical trials conducted by BMS in the U.S., Europe, and Canada, BMS decided to discontinue further development, thereby terminating the asset transfer agreement signed in 2023.
ORM-6151 was being developed for patients with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). It is an antibody-drug conjugate (DAC) that combines an antibody—which targets CD33 on the surface of cancer cells—with a degrading agent that eliminates specific intracellular proteins.
Unlike conventional antibody-drug conjugates (ADCs), which attach a cytotoxic drug to an antibody, DACs are designed to degrade disease-causing proteins inside cancer cells. ORM-6151 was developed to eliminate the GSPT1 protein, which plays a role in the survival of cancer cells. Orum Therapeutics, Inc. refers to this DAC platform as “TPD²-GSPT1.”
BMS licensed ORM-6151 in 2023 for a total of $180 million (approximately 234 billion won at the time). Orum Therapeutics, Inc. received an upfront payment of $100 million at that time. Although the company is not obligated to return the upfront payment it has already received following the termination of this agreement, it has forfeited up to $80 million in milestone payments that it would have been eligible to receive in the future.
This suspension marks the second time Orum Therapeutics, Inc. has halted a clinical trial, following its earlier decision to stop trials for “ORM-5029,” a DAC candidate it had been developing in-house. Consequently, the company now faces an even greater burden to demonstrate the platform’s efficacy and safety in human clinical trials.
In a regulatory filing, Orum Therapeutics, Inc. stated, “We plan to focus our R&D capabilities on our own pipeline using the DAC platform.”
