Sucampo Manufacturing and Research (SMR) is paying R-Tech Ueno (RTU) $3 million up front for rights to develop, manufacture and commercialize Rescula® (unoprostone) for its FDA-approved approved indication of glaucoma and ocular hypertension, in all regions except Japan, Taiwan, the Republic of Korea, China and North America. Sucampo does, in fact, already hold North American rights to the drug under a 2009 agreement with RTU, and is also developing unoprostone eye drops for treating atrophic age-related macular degeneration (AMD). Rescula is in addition approved in some European countries for the glaucoma and ocular hypertension indications.
The latest deal means SMR can develop the prostone-based drug for additional ophthalmic indications in its new geographical regions, and retains rights to all IP associated with the drug in its existing North American territory. RTU will earn additional development and commercialization milestones.
SMR says it aim to develop unoprostone for new indications including dry AMD and retinitis pigmentosa. “Unoprostone isopropyl has shown new potential in retinitis pigmentosa patients in an RTU-sponsored trial that showed dose-dependent improvement in retinal sensitivity after only six months of treatment,” remarks Ryuji Ueno, M.D., Sucampo CEO. “We will move forward to reactivate the licenses in Switzerland and the European Union for glaucoma and ocular hypertension as we continue our efforts to achieve a scientifically accurate and updated sNDA label in the U.S.