Ocugen to License OCU400 to Roots Pharmaceutical
The gene-therapy company locked in MENA commercial rights to its retinitis pigmentosa program with a 22% royalty and $255 million in potential sales milestones.
Ocugen, Inc. (OCGN) agreed to license OCU400, its modifier gene therapy for retinitis pigmentosa, to Roots Pharmaceutical for the Middle East and North Africa, converting a July term sheet into a definitive commercial partnership.
Under the agreement, Ocugen is to receive an upfront license fee and initial development payments of up to $4 million, potential sales milestones of up to $255 million, and royalties equal to 22% of net sales. The deal establishes strategic commercial reach across the Middle East and North Africa and advances the goal of enabling global patient access to potentially transformational gene therapies.
The structure mirrors the binding term sheet Ocugen signed on July 13 with Roots Pharmaceutical and its strategic partner Al-Dhow International Holding, which also contemplated a related supply agreement under which Ocugen would manufacture commercial supply of OCU400. That term sheet described the same $4 million in upfront and near-term development milestones, the $255 million in sales milestones, and the 22% royalty.
Dr. Shankar Musunuri, Chairman, Chief Executive Officer and Co-founder of Ocugen, said the partnership expands the company’s ability to bring a potential one-time gene therapy to patients in a region where retinitis pigmentosa is highly prevalent and unmet medical need is significant.
Retinitis pigmentosa is a leading cause of inherited vision loss globally, with notable prevalence across the MENA region. Ocugen’s gene-agnostic approach is designed to address multiple genetic mutations associated with RP with a single subretinal injection.
The MENA license is the second regional OCU400 partnership after a South Korea deal in November 2025, under which Ocugen is to receive up to $7.5 million in upfront and development milestones, sales milestones of $1.5 million for every $15 million of Korean sales, and a 25% royalty on net sales generated by the Korean partner. A regional approach preserves rights to larger geographies while generating potential returns for shareholders.
Enrollment in the OCU400 Phase 3 liMeliGhT trial is complete, with topline data expected in the first quarter of 2027 and a BLA submission to follow. Ocugen also completed OCU400 process performance qualification batches supporting BLA and commercial launch supplies.