FEB 05, 2013
Sucampo Pharmaceuticals, Inc. reports that the Japanese government will fund most of the phase 3 clinical development of unoprostone isopropyl for retinitis pigmentosa. Sucampo is co-developing unoprostone isopropyl with R-Tech Ueno and may file for FDA approval if the trials prove successful.
A form of unoprostone isopropyl is currently approved in the United States under the trade name Rescula for patients with open-angle glaucoma or ocular hypertension. The FDA has granted orphan drug designation to unoprostone isopropyl for treating retinitis pigmentosa.
The Japanese government's program provides companies up to 2 billion yen (approximately $22 million) in research and development funding for up to seven years. If successful, the company repays the total amount with royalties. If unsuccessful, the company repays 10 percent of the funding, with no interest.