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Ocugen signs OCU400 MENA license agreement
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Ocugen signs OCU400 MENA license agreement

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  • Ocugen signed a binding term sheet with Roots Pharmaceutical and Al-Dhow International Holding for OCU400 licensing rights in MENA.
  • The potential agreement could provide up to $4 million in upfront and near-term milestone payments plus sales milestones.
  • Ocugen said it continues advancing OCU400 through Phase 3 development for retinitis pigmentosa.

Ocugen (NASDAQ:OCGN) signed a binding term sheet with Roots Pharmaceutical and strategic partner Al-Dhow International Holding to negotiate an exclusive license for OCU400, its investigational modifier gene therapy for retinitis pigmentosa, across the Middle East and North Africa region.

The proposed agreement follows Ocugen’s efforts to expand commercial opportunities for OCU400 while continuing development through its Phase 3 liMeliGhT clinical trial.

Under the proposed terms, Ocugen could receive up to $4 million in upfront and near-term development milestone payments, cumulative sales milestones of up to $255 million and a 22% royalty on net sales generated by its partner.

Ocugen said it expects to manufacture commercial supply of OCU400 under a related supply agreement and plans to complete the definitive license agreement within 90 days.

OCU400 is a modifier gene therapy being developed for retinitis pigmentosa, an inherited retinal disorder that can lead to progressive vision loss.

Ocugen continues evaluating OCU400 in the Phase 3 liMeliGhT trial, with topline data expected in the first quarter of 2027 and a planned Biologics License Application submission afterward.

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