Under the terms of the agreement, Sucampo will hold the exclusive rights to commercialize Rescula in the US and Canada for the treatment of glaucoma and ocular hypertension. Sucampo also will have the right to develop Rescula for additional indications. Sucampo also will have the right of first refusal to commercialize in the US and Canada any additional indications for which Rescula is developed by RTU. RTU will be exclusively responsible for supply of Rescula to Sucampo for the US and Canada.
Sucampo will make an upfront payment to RTU of $3 million and will be responsible for additional milestone payments based on the achievement of specified development and commercialization goals. Sucampo will be responsible for the development, regulatory, and commercialization activities and expenses for Rescula in the US and Canada.
Rescula was approved by the FDA for the treatment of open-angle glaucoma and ocular hypertension in 2000. In addition to these approved indications, Sucampo management believes that Rescula has the potential to be a treatment for dry age-related macular degeneration (dry AMD). As a result, Sucampo plans to initiate a Phase II clinical trial with Rescula for dry AMD in 2010.
Ryuji Ueno, chairman and CEO of Sucampo Pharmaceuticals, said: “We are very pleased to add Rescula to Sucampo’s product portfolio, alongside Amitiza. We look forward to re-launching Rescula for its currently approved indications and to developing it as a potential treatment for dry AMD. We believe Rescula will be an important and integral part of our product portfolio.
“Both Rescula and Amitiza are created from the prostone technology whose therapeutic potential I discovered in the 1980s and is also the basis for Sucampo’s clinical and preclinical pipeline compounds. Rescula targets disorders caused by the aging process, which is consistent with the commercial focus of Sucampo and one of my abiding passions.”