Ocugen, Inc. (NASDAQ: OCGN) announced the signing of a binding term sheet for a licensing agreement with a well-established Korean pharmaceutical and healthcare leader, granting exclusive Korean rights to OCU400, the company's novel modifier gene therapy for retinitis pigmentosa (RP). The deal structure positions Ocugen to receive over $161 million in total potential value through upfront payments, milestones, and royalties.
Financial Terms and Structure
Under the licensing agreement, Ocugen will receive upfront license fees and near-term development milestones totaling up to $11 million. The company will be entitled to sales milestones of $1 million for every $15 million of net sales in Korea, potentially generating $150 million or more in the first 10 years of commercialization. Additionally, Ocugen will receive a 25% royalty on net sales of OCU400 generated by its Korean partner.
The agreement also includes a supply component, with Ocugen retaining manufacturing and commercial supply responsibilities for OCU400 under a separate supply agreement.
Market Opportunity and Strategic Rationale
The Korean market represents a significant opportunity, with an estimated 15,000 individuals in the Republic of Korea affected by retinitis pigmentosa. Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen, emphasized the strategic alignment of the deal: "This regional licensing agreement is aligned with our business development strategy to partner with well-established companies in their respective countries and regions—leveraging their networks and know-how to treat as many RP patients as possible."
The regional approach allows Ocugen to preserve rights to larger geographies while maximizing patient reach and generating shareholder returns. According to Musunuri, "A regional approach preserves Ocugen's rights to larger geographies to maximize total patient reach while also generating return for our shareholders."
Development Timeline and Regulatory Path
OCU400 is currently advancing through Phase 3 clinical development, with Ocugen targeting a Biologics License Application (BLA) filing by mid-2026. The definitive licensing agreement is expected to be executed within the next 60 days, with additional details to be disclosed upon completion.
About OCU400 and Ocugen's Platform
OCU400 represents Ocugen's breakthrough modifier gene therapy platform, which utilizes a gene-agnostic approach to address significant unmet medical needs for large patient populations. The company positions itself as a biotechnology leader focused on discovering, developing, and commercializing novel gene therapies for major blindness diseases.
The licensing deal demonstrates Ocugen's commitment to expanding global access to its gene therapy innovations while building a sustainable commercial model through strategic partnerships in key international markets.
