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Capricor Therapeutics and Nippon Shinyaku Enter Partnership for Exclusive Commercialization and Distribution of CAP-1002 for the Treatment of Duchenne Muscular Dystrophy in the U.S.
-Partnership Leverages Nippon Shinyaku’s Deep Experience in Drug Development for Rare Diseases and its Commercial DMD Franchise in the U.S.- -Capricor to
About this update from Capricor Therapeutics, Inc.
[{"type":"text","content":"-Partnership Leverages Nippon Shinyaku’s Deep Experience in Drug Development for Rare Diseases and its Commercial DMD Franchise in the U.S.- -Capricor to Receive an Upfront Payment of $30 Million, Additional Potential Milestone Payments of up to $705 Million- -Capricor to Receive Meaningful Double-Digit Percentage of Revenue Based on Product Sales- -Pivotal Phase 3, HOPE-3 Trial Cleared by FDA to Proceed, Initiation of Trial Underway- SAN DIEGO, Jan. 25, 2022 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR) (“Capricor” or “the Company”), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of a broad spectrum of diseases, announced today that it has entered into a partnership with Nippon Shinyaku Co., Ltd., a Japanese pharmaceutical company listed on the TYO (US subsidiary: NS Pharma), for the exclusive commercialization and distribution in the United States of Capricor’s lead asset, CAP-1002, for the treatment of Duchenne muscular dystrophy (DMD), a rare neuromuscular disease with limited treatment options. Capricor’s proprietary cell therapy, CAP-1002, is comprised of human allogeneic cardiosphere-derived cells, which have demonstrated positive results in patients with DMD. CAP-1002’s mechanism of action is immunomodulatory and regenerative and its broad applicability makes it suitable for patients regardless of genetic mutation. HOPE-Duchenne and HOPE-2, the Phase 1 and Phase 2 clinical trials using CAP-1002 to treat late-stage DMD patients, showed statistically significant improvements in upper limb and/or cardiac function in the treatment groups. HOPE-3, the Phase 3 clinical trial that will be supported by this partnership, will commence shortly and is expected to be the pivotal trial for CAP-1002 in DMD. The regulatory pathway for CAP-1002 is supported by RMAT (Regenerative Medicine Advanced Therapy Designation) as well as Orphan Drug Designation. If Capricor were to receive market approval for CAP-1002 by the FDA, Capricor would be eligible to receive a Priority Review Voucher based on its designation as a rare pediatric disease. Under the terms of the agreement, Capricor will be responsible for the conduct of HOPE-3 as well as the manufacturing of CAP-1002. Nippon Shinyaku will be responsible for the distribution of CAP-1002 in t...