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Omecamtive mecarbil is not included in the collaborative programs of Amgen Astellas BioPharma and Astellas Pharma Inc.
Data Supports Inclusion of Japan in
Global Phase 3 Cardiovascular Outcomes Study GALACTIC-HF
TOKYO (August 7, 2017) – Amgen Astellas BioPharma K.K. (Headquarters, Tokyo; President and Representative Director: Steve Sugino, “Amgen Astellas”) today announced that the Phase 2 clinical trial of omecamtiv mecarbil in Japanese patients with heart failure has met its pharmacokinetic primary endpoint and demonstrated statistically significant improvements in systolic ejection time (SET), a secondary endpoint. The pharmacokinetics, pharmacodynamics, safety, and tolerability data from this trial were consistent with previously reported results from COSMIC-HF. Omecamtiv mecarbil, a novel investigational cardiac myosin activator that increases cardiac contractility, is being developed by Amgen in collaboration with Cytokinetics for the potential treatment of heart failure.
“We believe omecamtiv mecarbil has the potential to be a new therapy for Japanese heart failure patients who continue to suffer from this chronic disease, including frequent hospitalizations. We, Amgen Astellas, will make every effort to support further study in Japanese patients and look forward to working with Amgen and Cytokinetics on the Phase 3 cardiovascular outcomes study GALACTIC-HF for omecamtiv mecarbil,” said Kurt Helge Rimkus, M.D., Head of Research and Development at Amgen Astellas.
Dr. Shinichi Momomura, Director of Jichi Medical University Saitama Medical Center and the principal investigator in Japan, said, “There are still many patients in Japan whose heart failure has gradually worsened despite broad use of standard treatments and advances in care. Omecamtiv mecarbil may offer Japanese physicians a new treatment option for heart failure patients who are not well controlled with currently available therapies.”
Design of Phase 2 Clinical Trial in Japan
This Phase 2 clinical trial in Japanese patients with heart failure was designed to assess the pharmacokinetics of omecamtiv mecarbil as well as its effect on cardiac function, safety and tolerability in Japanese patients with chronic heart failure. The trial randomized 81 patients 1:1:1:1 to placebo, 25 mg of omecamtiv mecarbil twice daily and two separate PK-based titration groups in which the dose of omecamtiv mecarbil could be increased from 25 to 37.5 mg or 50 mg twice daily based on the pre-dose concentration of omecamtiv mecarbil at week 2. Patients received study drug for 16 weeks after randomization. The primary endpoint was to assess the plasma concentrations of omecamtiv mecarbil at weeks 2, 4, 12 and 16, and the area under the curve (AUC) at week 8. The secondary endpoint was to assess the change from baseline in SET measured by echocardiography at week 16.
GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) is a Phase 3 double-blind, randomized, placebo-controlled multicenter clinical trial designed to determine if treatment with omecamtiv mecarbil when added to standard of care is superior to standard of care plus placebo in reducing the risk of cardiovascular death or heart failure events in patients with high risk chronic heart failure and reduced ejection fraction. GALACTIC-HF is planned to enroll approximately 8,000 symptomatic chronic heart failure patients in over 800 sites in 34 countries who are either currently hospitalized for a primary reason of heart failure or have had a hospitalization or admission to an emergency room for heart failure within one year prior to screening. GALACTIC-HF is being conducted under a Special Protocol Assessment (SPA) with the U.S. FDA.
About Omecamtiv Mecarbil
Omecamtiv mecarbil is a novel cardiac myosin activator. Cardiac myosin is the cytoskeletal motor protein in the cardiac muscle cell that is directly responsible for converting chemical energy into the mechanical force resulting in cardiac contraction. Cardiac myosin activators are thought to accelerate the rate-limiting step of the myosin enzymatic cycle and shift the enzymatic cycle in favor of the force-producing state. Preclinical research has shown that cardiac myosin activators increase contractility in the absence of changes in intracellular calcium in cardiac myocytes1.
Omecamtiv mecarbil is being developed by Amgen in collaboration with Cytokinetics. Amgen holds an exclusive, worldwide license to omecamtiv mecarbil and related compounds, subject to Cytokinetics’ specified development and commercialization rights. Amgen has also entered an alliance with Servier for exclusive commercialization rights in Europe as well as the Commonwealth of Independent States, including Russia. Servier contributes funding for development and provides strategic support to the program.
About Amgen Astellas BioPharma K.K.
Amgen Astellas BioPharma is a Japanese company that began operations on October 1, 2013, to provide breakthrough-science-based medicines to help address unmet medical needs of patients in Japan. The company is a joint venture between Amgen, one of the world’s leading independent biotechnology companies, and Astellas Pharma Inc., a leading Tokyo-based R&D oriented global pharmaceutical company.
AABP has grown into an organization with over 400 employees and comprehensive functions to be fully operational as a marketing authorization holder in Japan. The joint venture will become a wholly-owned Amgen affiliate as soon as 2020.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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