MALVERN, PA — Ocugen Inc. (NASDAQ: OCGN) has signed a binding term sheet that could generate up to $259 million in licensing and sales milestone payments, plus ongoing royalties, as the biotechnology company expands commercialization plans for its experimental gene therapy for retinitis pigmentosa into the Middle East and North Africa.
The company disclosed that it intends to negotiate a definitive licensing agreement with Roots Pharmaceutical and its strategic partner, Al-Dhow International Holding, granting exclusive rights to develop and commercialize OCU400 across the MENA region. The companies expect to execute the final agreement within 90 days.
Under the proposed terms, Ocugen would receive up to $4 million in upfront licensing fees and near-term development milestone payments. The agreement also includes up to $255 million in sales milestone payments and a 22% royalty on net sales generated by its regional partner.
Ocugen would retain responsibility for manufacturing commercial supplies of OCU400 under a separate supply agreement.
The transaction expands Ocugen’s strategy of securing regional commercialization partners ahead of potential regulatory approval for OCU400, an investigational modifier gene therapy being developed to treat retinitis pigmentosa, an inherited retinal disease that causes progressive vision loss. The company cited a relatively high prevalence of the disease across the MENA region as a factor supporting the partnership.
“This step forward represents an important milestone in our effort to advance OCU400 regional partnership strategy,” Chairman, Chief Executive Officer and Co-founder Dr. Shankar Musunuri stated. “By partnering with an established leader with strong reach across the Middle East and North Africa, we are expanding our ability to bring this one-time potential treatment for life to a region where RP is highly prevalent.”
Ocugen is continuing its Phase 3 liMeliGhT clinical trial of OCU400, with topline results expected during the first quarter of 2027. If the trial is successful, the company plans to submit a Biologics License Application to the U.S. Food and Drug Administration thereafter.
Additional financial and operational details of the regional licensing agreement are expected after the parties execute a definitive contract.
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