Pharmabio Enters Exclusive Distribution Agreement with Rohto Pharmaceutical for Regenerative Medicine Product

Overview of the Partnership

Pharmabio Co., Ltd. has announced that it has entered into 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 for the treatment of myopic choroidal atrophy. Under this agreement, Pharmabio will lead the efforts to obtain manufacturing and marketing approval and handle National Health Insurance (NHI) drug price listing procedures as the marketing authorization holder, while Rohto Pharmaceutical will undertake exclusive distribution within Japan.

Purpose and Background of the Partnership

"PAL-222" is a regenerative medicine product utilizing Pharmabio's proprietary cell sheet technology, holding promise as a novel therapeutic approach for myopic choroidal atrophy, for which no established treatments currently exist. By having Pharmabio act as the distributor and Rohto Pharmaceutical as the sales partner, the collaboration aims to rapidly provide and disseminate new treatment options for patients. Under the terms of the agreement, Pharmabio will receive an upfront payment, along with development and sales milestones, as well as royalties from Rohto Pharmaceutical.

Clinical Trial Results

"PAL-222" has successfully met its primary endpoints in the Phase I/IIa clinical trial (PAMyCA trial). The trial results demonstrated the suppression of the enlargement of choroidal atrophy areas, along with the potential to maintain visual function and a favorable safety profile. Based on these findings, the company plans to submit a marketing authorization application aiming for conditional and time-limited approval.

Future Outlook

Through this partnership, both companies will strengthen their collaboration to deliver new treatment options as quickly as possible to patients suffering from myopic choroidal atrophy, an area with high unmet medical needs. Moving forward, the companies intend to accelerate the process toward obtaining regulatory approval and NHI reimbursement, thereby promoting its practical implementation in society.