Core Viewpoint - Ocugen has entered into a licensing agreement with Kwangdong Pharmaceutical for exclusive rights to OCU400 in Korea, a gene therapy for retinitis pigmentosa, which is expected to significantly impact the treatment landscape for this condition in the region [1][4]. Financial Summary - Ocugen will receive upfront license fees and near-term development milestones totaling up to $7.5 million [2]. - The company is entitled to sales milestones of $1.5 million for every $15 million in sales in Korea, with projected sales reaching $180 million or more in the first 10 years [2]. - A royalty of 25% on net sales of OCU400 generated by Kwangdong will also be received by Ocugen [2]. Market Opportunity - There are approximately 7,000 individuals in South Korea with retinitis pigmentosa, representing about 7% of the U.S. market [3]. - The partnership with Kwangdong is expected to help thousands of patients facing vision loss upon regulatory approval of OCU400 in Korea [3]. Company Profiles - Ocugen is a biotechnology company focused on developing gene therapies for blindness diseases, aiming to address significant unmet medical needs [7]. - Kwangdong Pharmaceutical is a leading healthcare company in Korea, involved in the development and commercialization of pharmaceutical products, with a strong focus on innovation and research [8][9]. Development Status - Ocugen is advancing OCU400 through Phase 3 clinical development, with a target for a U.S. Biologics License Application filing in 2026 [5]. - Kwangdong plans to utilize Ocugen's clinical data and BLA filing for their regulatory submission in Korea [6].
Ocugen, Inc. and Kwangdong Pharmaceutical Co., Ltd. Complete License Agreement of OCU400 Modifier Gene Therapy for Retinitis Pigmentosa in Korea