Ocugen, Inc. executed a licensing agreement with Kwangdong Pharmaceutical Co. Ltd., for the exclusive Korean rights to OCU400--Ocugen's novel modifier gene therapy for retinitis pigmentosa (RP). Pursuant to the License Agreement, Ocugen will receive upfront license fees and near-term development milestones totaling up to $7.5 million.
The Company will be entitled to sales milestones of $1.5 million for every $15 million of sales in Korea, projected to reach $180 million or more in the first 10 years of commercialization. Additionally, Ocugen will receive a royalty of 25% on net sales of OCU400 generated by Kwangdong. Ocugen will manufacture the commercial supply of OCU400 under terms of a supply agreement.
There are an estimated 7,000 individuals in the Republic of Korea with RP, which represents approximately 7% of the U.S. market. OCU400 provides the opportunity for partner to help thousands of patients facing vision loss. Upon regulatory approval of OCU400 in Korea, the company believe Kwangdong will become a leader in the field of ophthalmic gene therapy in Korea.
Ocugen is currently advancing OCU400 through Phase 3 clinical development with a target U.S. Biologics License Application (BLA) filing in 2026. Kwangdong intends to utilize Ocugen's clinical data and BLA filing as part of their regulatory submission for approval in Korea.
