Business
Cytokinetics Regains Rights to Develop and Commercialize Omecamtiv Mecarbil and AMG 594 From Amgen
Company Committed to Advancing Omecamtiv Mecarbil with Initial Focus on Preparations for Regulatory Interactions Following Positive Results of GALACTIC-HF
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"Company Committed to Advancing Omecamtiv Mecarbil with Initial Focus on Preparations for Regulatory Interactions Following Positive Results of GALACTIC-HF\n Company to Host Conference Call and Webcast Today at 8:30 AM Eastern Time SOUTH SAN FRANCISCO, Calif., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that Amgen has elected to terminate the Collaboration and Option Agreement, dated December 20, 2006 between the companies (the “Agreement”) and thereby end its collaboration with Cytokinetics, effective May 20, 2021, and intends to transition development and commercialization rights for omecamtiv mecarbil and AMG 594 to Cytokinetics. Omecamtiv mecarbil is an investigational cardiac myosin activator, developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF), and was recently studied in GALACTIC-HF, a positive Phase 3 cardiovascular outcomes clinical trial. AMG 594, a novel mechanism cardiac troponin activator, is in Phase 1 development for HFrEF and other types of heart failure. “We believe this is an important pivot point and opportunity for our company, as we reclaim omecamtiv mecarbil following positive Phase 3 clinical trial results,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “In one of the largest heart failure clinical trials ever conducted, our novel mechanism drug candidate demonstrated positive efficacy in a diverse patient population with high unmet need and without an imbalance in the overall incidence of adverse events. We look forward to rapidly advancing next steps for omecamtiv mecarbil, which we expect will include discussions with regulatory authorities. We believe we are well prepared to press forward given our strong balance sheet and pioneering leadership in the development of muscle-directed therapies.” Terms of Termination Pursuant to the terms of the Agreement, upon the effective date of Amgen’s termination, research, development and commercialization rights for compounds, including omecamtiv mecarbil and AMG 594, will transition to Cytokinetics. In addition, Amgen will have certain obligations set forth in the Agreement, including: cooperating with Cytokinetics and its designee(s) to facilitate a reasonably smooth, orderly and prompt transition of the programs, including transfer and assignment...