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Ocugen and Celairis Therapeutics Enter into Exclusive License Agreement for OCU400 in Australia, New Zealand, and ASEAN

  • Celairis secures exclusive rights to commercialize Ocugen's investigational modifier gene therapy OCU400 for retinitis pigmentosa across Australia, New Zealand, & ASEAN markets.
  • The partnership expands potential access to a one-time treatment for RP in a region of approximately 725 million people following potential U.S. approval.
  • Ocugen will receive an upfront license fee, potential development & milestone payments totaling up to $7.1 million, a high single-digit percentage royalty on net sales, & 50% of gross profits from regional sales.
  • The $7.1 million payment package includes $6.1 million linked to the upfront fee & OCU400 top-line results expected in the first quarter of 2027.
  • Celairis will manage regional regulatory submissions, market access, & commercialization, while Ocugen will manufacture & supply OCU400 under a planned supply agreement.
  • OCU400 is currently in the Phase 3 liMeliGhT clinical trial for RP, with top-line data expected in Q1 2027 & global regulatory submissions planned thereafter.
  • The agreement marks Ocugen's third strategic regional partnership for OCU400, aimed at enhancing global patient access to its gene-agnostic modifier therapy platform.
Company
Ocugen
Keywords
Nasdaq:OCGN, Ocugen