Regenerative Medicine Firm Pharmabio Enters into Exclusive Domestic Distribution Agreement with Rohto Pharmaceutical for Myopic Chorioretinal Atrophy Treatment

Overview of the Release

Pharmabio Corporation has announced that it has concluded an exclusive distribution agreement in Japan with Rohto Pharmaceutical Co., Ltd. for "PAL-222," a human (allogeneic) adipose-derived mesenchymal stromal cell sheet currently under development by the company. Under this partnership, Pharmabio will be responsible for obtaining manufacturing and marketing approval as well as drug pricing reimbursement procedures, while Rohto Pharmaceutical will handle exclusive distribution within the Japanese market.

Product under Development and Clinical Status

"PAL-222" is a regenerative medicine product targeting myopic chorioretinal atrophy, a condition for which no effective treatments have yet been established. Phase I/IIa clinical trials (the PAMyCA trial) have confirmed its potential to inhibit the expansion of chorioretinal atrophy area and maintain visual function, alongside a favorable safety profile. Moving forward, the company plans to submit an application aiming for conditional and time-limited approval.

Background and Purpose of the Business Partnership

Pharmabio operates its own manufacturing plant within the Life Innovation Center in Kawasaki City, Kanagawa Prefecture, establishing an integrated system spanning from research and development to the manufacturing of cellular medicines. By leveraging Rohto Pharmaceutical's extensive sales network through this agreement, the companies aim to deliver new treatment options to patients at the earliest possible date. In addition to an upfront payment, Pharmabio will receive milestone payments and royalties based on development progress, regulatory approval, and sales performance.