jCyte Inc. announced it has entered into a licensing agreement with Santen Pharmaceutical to develop and commercialize its first-in-class, investigational therapy, jCell, outside the United States, in regions including Europe, Asia, and Japan.
Under the terms of the licensing agreement, jCyte will receive $50 million in upfront cash, $12 million in a convertible note offering, and $190 million in clinical and sales milestones based on regulatory approval and initial sales in Europe, Asia, and Japan. The total deal is valued at up to $252 million. jCyte is also entitled to receive tiered, double-digit royalty payments on net sales of jCell therapy once commercialized outside the U.S.
“We are thrilled to partner with Santen, a global market-leader in ophthalmology. By leveraging Santen’s large, existing global commercial and medical infrastructure in ophthalmology, as well as its commitment to commercializing cell and gene therapies, we help ensure that more patients with retinitis pigmentosa who live outside the U.S. will have access to this technology,” Paul Bresge, Chief Executive Officer, jCyte, said in a company news release. “We intend to use the proceeds from this transaction to continue development of our lead investigational therapy jCell, to improve the lives of patients with retinitis pigmentosa, as well as other degenerative retinal diseases.”
jCell is a first-in-class investigational treatment for retinitis pigmentosa, an inherited retinal disease. The treatment is a minimally-invasive intravitreal injection, which can be performed in an ophthalmologist’s office with topical anesthetic. The entire procedure takes less than 30 minutes. The principal mechanism of action is the release of neurotrophic factors that may rescue diseased retinal cells. jCell therapy aims to preserve vision by intervening in the disease at a time when host photoreceptors can be protected and potentially reactivated. jCell has been developed with support from the California Institute for Regenerative Medicine (CIRM), which has funded previous preclinical development and ongoing clinical studies.
In the United States, the evaluable portion of a phase 2b clinical trial of jCell for the treatment of retinitis pigmentosa has been completed, and the crossover portion continues. jCell therapy has been administered in over 100 patients. The FDA has granted jCyte Regenerative Medicine Advanced Therapy (RMAT) designation based on early clinical data, making jCell potentially eligible for BLA priority review. In addition to RMAT, jCell has received Orphan Drug designation from the FDA and the European Medicines Agency (EMA).