Ono has secured exclusive rights to develop IgG-degrading drugs in key Asian markets through a partnership with US-based Biohaven. The agreement involves an upfront payment of $80 million and aims to expand Ono's pipeline beyond oncology into autoimmune diseases.
Ono acquired exclusive rights to develop and commercialize Biohaven's low-molecular IgG-degrading assets, specifically BHV-1300, BHV-1310, and BHV-1320, in Japan, South Korea, Taiwan, and ASEAN countries. These assets were developed using Biohaven's proprietary MoDE platform. The deal requires Ono to pay an upfront fee of $80 million, with potential milestone payments of up to $20 million tied to development progress. Additionally, Ono will pay royalties of approximately 20% on future sales.
Ono will oversee clinical trials and regulatory approvals in the target regions, handling commercialization post-approval. This partnership strengthens Ono's pipeline in late-stage development for immune and inflammatory diseases. Biohaven CEO Vlad Coric praised Ono's execution capabilities, noting that combining BHV-1300 with Ono's commercial strength will deliver treatments to patients more quickly.
The IgG-degrading assets selectively remove self-antibodies of subclasses IgG1, IgG2, and IgG4, which cause autoimmune diseases. By utilizing intrinsic proteolytic mechanisms, these drugs are expected to represent a new class of therapeutics. BHV-1300 is currently the most advanced in development, undergoing global Phase 3 trials for Graves' disease. It features an autoinjector formulation for self-administration.
Graves' disease is the most common cause of hyperthyroidism, primarily affecting women in their 20s and 30s. Current standard treatments, including antithyroid drugs, radioactive iodine, and surgery, do not directly target TRAb, the autoantibody responsible for the disease. Approval of this drug would offer a groundbreaking option addressing the root cause, potentially benefiting a broad patient population with a prevalence of 0.2 to 3.2 per 1,000 people. Ono plans to leverage its strong commercial base in Asia to deploy this innovation rapidly.
Ono disclosed that the financial impact of this agreement on its consolidated results for the fiscal year ending March 2027 will be minimal. The total potential value, including milestones, could reach $100 million, but most of these payments are contingent on development success and progress, meaning only a limited amount is expected to be recognized as revenue in the current period.
Strategically, this partnership fills a gap in Ono's product portfolio for the immune disease sector. Since BHV-1300 is in Phase 3 trials for Graves' disease, accumulating robust clinical data will be crucial for regulatory approval. If the drug gains market traction, Ono can expect revenue growth through both royalties and its own sales network. Drawing on its successful global oncology commercialization experience, Ono aims to solidify its position in the Asian immune disease treatment market.
Analyst take
While Ono has traditionally focused on M&A and license-ins in oncology, this move signals a strategic entry into autoimmune diseases. Securing exclusive Asian rights aims to build a new revenue pillar. The $80 million upfront fee is relatively modest, suggesting a prudent approach to sharing development risk while limiting initial investment. Success hinges on the Phase 3 trial results for BHV-1300, which could significantly add value to Ono's portfolio if successful.
