By Fineline Cube 
Merck Sharp & Dohme Inc. (MSD, NYSE: MRK), through its 2023 acquisition of Prometheus BioSciences, announced today that it has terminated the co‑development and co‑commercialization agreement with Dr. Falk Pharma GmbH (Falk) for the anti‑CD30 ligand monoclonal antibody MK‑8690 (formerly PRA‑052). Under the settlement, MSD now holds sole responsibility for the entire MK‑8690 development program and will assume full commercial rights worldwide.
Deal Overview
| Item | Details |
|---|---|
| Parties | MSD (via Prometheus BioSciences) & Falk Pharma |
| Asset | MK‑8690 (anti‑CD30L monoclonal antibody) – early‑stage clinical candidate |
| Original 2020 Agreement | Joint development; Falk covered 25 % of costs and held exclusive rights in Europe, Australia & New Zealand. Prometheus retained U.S. and “rest‑of‑world” rights. |
| Current Settlement | Full global rights transferred to MSD; Falk receives US$150 million upfront plus potential milestone payment and royalty stream on sales in its former territories. |
| Milestone/Royalty | Specific milestone amount undisclosed; royalty rate to be negotiated per territory. |
| Effective Date | Agreement executed 5 Nov 2025; rights transfer effective immediately. |
Background – Prometheus Acquisition
- 2023 – MSD acquired Prometheus BioSciences for its pipeline, including the CD30L antibody MK‑8690 and the TL1A antibody.
- MK‑8690 – Investigational monoclonal antibody targeting the CD30 ligand, currently in Phase 1/2 safety and dose‑escalation studies for hematologic malignancies.
- Strategic Fit – The drug aligns with MSD’s oncology portfolio and its push into next‑generation immuno‑oncology therapies.
Financial & Strategic Implications
- Cash Outlay – The US$150 million upfront payment represents a modest cash commitment relative to the estimated $1‑$2 billion development cost required to bring MK‑8690 to market.
- Risk Consolidation – By assuming 100 % of development risk, MSD can streamline trial design, regulatory filing, and commercial strategy without cross‑licensing constraints.
- Market Opportunity – CD30L is a validated target in Hodgkin lymphoma, anaplastic large‑cell lymphoma, and emerging solid‑tumor indications. Successful development could add $3‑$5 billion in peak sales potential.
- Royalty Income for Falk – Falk retains a royalty stream on sales in Europe, Australia and New Zealand, providing a long‑term upside without further capital exposure.
Outlook & Next Steps
- Clinical Program – MSD plans to accelerate the Phase 1/2 trial, targeting a mid‑2026 read‑out for safety and preliminary efficacy.
- Regulatory Path – Early engagement with the FDA, EMA, and PMDA to explore accelerated pathways (e.g., Fast Track, PRIME).
- Commercial Planning – Integration of MK‑8690 into MSD’s global oncology sales force and potential partnership with regional biotech firms for late‑stage development.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the development timeline, regulatory strategy, and commercial potential of MK‑8690. Actual results may differ due to clinical outcomes, regulatory decisions, and market conditions.-Fineline Info & Tech