jCyte Inc. Enters into Ex-US Licensing and Commercialization Agreement for jCell Therapy with Global Ophthalmology Leader Santen Pharmaceutical
- Category: DNA RNA and Cells
- Published on Sunday, 10 May 2020 13:32
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- jCyte to receive up to $252 million, inclusive of $50 million in upfront cash, $12 million in a convertible note offering, and milestone payments of up to $190 million in potential milestones in Europe, Asia and Japan, as well as tiered, double-digit royalties on net commercial sales for jCell in all regions outside the U.S.
- Agreement leverages Santen’s extensive global ophthalmology sales network, capabilities and infrastructure to the benefit of patients outside of U.S.
- jCell is a first-in-class investigational treatment which has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation; evaluable portion of a U.S. Phase 2b clinical trial of jCell for the treatment of retinitis pigmentosa has been completed
NEWPORT BEACH, CA, USA I May 08, 2020 IjCyte Inc., a biotech company dedicated to improving the lives of patients with rare degenerative retinal diseases, today announced it has entered into a licensing agreement with Santen Pharmaceutical to develop and commercialize its first-in-class, investigational therapy, jCell, outside the U.S., 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,” said Paul Bresge, Chief Executive Officer, jCyte, Inc. “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 U.S. Food and Drug Administration (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).
About Retinitis Pigmentosa (RP)
Retinitis pigmentosa is a rare, genetic condition that progressively destroys the rod and cone photoreceptors in the retina. It often strikes people in their teens, with many patients rendered legally blind by middle age. Worldwide, an estimated 1.9 million people suffer from the disease, including approximately 100,000 people in the U.S., making it the leading cause of inheritable blindness.
About jCyte, Inc.
jCyte, Inc. is a clinical-stage biotech company focused on developing jCell therapy for retinitis pigmentosa (RP) and other degenerative retinal disorders. jCell is a first-in-class investigational treatment for retinitis pigmentosa, an inherited retinal disease. The treatment is minimally-invasive and given as an intravitreal injection. There are currently no FDA approved therapies for RP. The company is pioneering a new era of regenerative therapies to treat patients with unmet medical need. For more information, visit www.jcyte.com.
As a specialized company dedicated to ophthalmology, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices. Santen is the market leader for prescription ophthalmic pharmaceuticals in Japan and its products now reach patients in over 60 countries. With scientific knowledge and organizational capabilities nurtured over a nearly 130-year history, Santen provides products and services to contribute to the well-being of patients, their loved ones and consequently to society. For more information, please visit Santen’s website (www.santen.com).