Ocugen and Celairis Therapeutics have entered an exclusive license agreement granting Celairis rights to commercialize OCU400, Ocugen's investigational modifier gene therapy for retinitis pigmentosa, in Australia, New Zealand and ASEAN markets.
Under the terms, Ocugen will receive an upfront license fee and potential development and milestone payments totaling up to $7.1 million, including $6.1 million associated with the upfront payment and OCU400 topline results expected in the first quarter of 2027. Ocugen will also receive a high single-digit percentage royalty on net sales and 50% of gross profits from OCU400 net sales in the territory. The parties expect to enter a supply agreement under which Ocugen will manufacture and supply the product, while Celairis will be responsible for regional regulatory submissions, market access and commercialization.
Ocugen Chairman and CEO Dr. Shankar Musunuri said establishing a partnership with a regional company like Celairis and its local network is critical to the company's goal of global patient access, and that the agreement marks its third strategic regional partnership for OCU400.
OCU400 is an investigational therapy for RP, a group of inherited retinal diseases causing progressive vision loss and, in many cases, blindness. The product has not been approved or registered in any market in the territory. Ocugen is conducting the Phase 3 liMeliGhT clinical trial, with topline data expected in the first quarter of 2027, followed by planned global regulatory submissions including a Biologics License Application in the U.S. and a Marketing Authorization Application in Europe. Regulatory submissions in the territory are expected to follow.
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