Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that the Japan Science and Technology Agency (JST) has adopted unoprostone isopropyl ophthalmic solution .15% in the Adaptable and Seamless Technology Transfer Program. As part of this program, R-Tech Ueno, Sucampo’s development partner, has signed an agreement for unoprostone isopropyl with the JST in which the Japanese government shall provide the majority of funding* for Phase 3 clinical development costs for unoprostone isopropyl for retinitis pigmentosa (RP). Sucampo is co-developing unoprostone isopropyl with R-Tech Ueno and may file for FDA approval of the product for retinitis pigmentosa (RP) in the future assuming the successful trials.
A form of unoprostone isopropyl, trade name RESCULA ®, is currently approved in the United States for use in patients with open-angle glaucoma or ocular hypertension. The FDA has granted orphan drug designation to unoprostone isopropyl for treatment of RP.
Retinitis pigmentosa is a genetic disease characterized by progressive, irreversible vision loss and decreasing visual acuity. As RP progresses, daily life becomes increasingly more difficult. Blindness from all causes is among the most significant injuries to a patient’s qualify of life and is a major driver of patient-based cost of care and lifestyle maintenance. There are no drugs or therapeutic procedures currently approved for the treatment of RP today.
“Sucampo congratulates our partner, R-Tech Ueno, for being the only project of 17 who applied to be selected for this prestigious Technology Transfer Program. Much like the FDA’s orphan drug designation for unoprostone isopropyl for retinitis pigmentosa, Sucampo is pleased that the Japan Science and Technology Agency has recognized the potential unoprostone isopropyl may hold to be a treatment for RP, an illness with significant impact for so many patients who currently have no other treatment options,” said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Executive Officer, and Chief Scientific Officer of Sucampo. “In addition, we are looking forward to the US launch of RESCULA for IOP-lowering in glaucoma and ocular hypertension later this quarter.”