Cytokinetics Regains European Rights to Omecamtiv Mecarbil

IndustryPRwire -- Cytokinetics announced that Amgen notified the company that Les Laboratoires Servier and Institut de Recherches Internationales Servier (“Servier”) elected to terminate the sublicense agreement between Amgen and Servier (the “Servier Agreement”) for the development and commercialization of omecamtiv mecarbil in Europe and the Commonwealth of Independent States, including Russia. The termination is effective as of March 18, 2021, after which all development, commercialization and other rights with respect to omecamtiv mecarbil previously granted by Amgen to Servier will revert to Amgen. Cytokinetics recently announced that Amgen terminated the Collaboration and Option Agreement between Amgen and Cytokinetics effective May 20, 2021. Given Servier’s notice to Amgen, all worldwide rights related to the development and commercialization of omecamtiv mecarbil will now return to Cytokinetics on that date.

Omecamtiv mecarbil, an investigational cardiac myosin activator, developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF), was recently studied in GALACTIC-HF, a positive Phase 3 cardiovascular outcomes clinical trial. Cytokinetics announced that it intends to seek feedback from regulatory authorities in 2021 as may inform potential regulatory strategies. The company also expects to evaluate strategic options for the potential co-commercialization and licensing of omecamtiv mecarbil.

“We are pleased to proceed into 2021 with clarity regarding omecamtiv mecarbil. We look forward to engaging regulatory authorities next year with the objective to assess potential regulatory paths while also continuing our commercial planning activities.” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Primary efficacy results as well as supplemental analyses from GALACTIC-HF point to potentially clinically relevant effects of omecamtiv mecarbil in patients with heart failure. We plan to evaluate a wide range of corporate development strategies for both co-commercialization and licensing deals to inform our goal to bring our novel mechanism drug candidate to patients suffering from heart failure.”

GALACTIC-HF: Primary Results and Supplemental Analyses

Primary results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 event-driven cardiovascular outcomes clinical trial of omecamtiv mecarbil, were recently presented at the American Heart Association (AHA) Scientific Sessions 2020, and were simultaneously published in the New England Journal of Medicine.1

GALACTIC-HF, one of the largest Phase 3 global cardiovascular outcomes trials in heart failure ever conducted, enrolled 8,256 patients who were at risk of hospitalization and death, despite being well treated on standard of care therapy. After a median duration of follow-up of 21.8 months, the trial demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint of cardiovascular (CV) death or heart failure events (heart failure hospitalization and other urgent treatment for heart failure) compared to placebo in patients treated with standard of care. A first primary endpoint event occurred in 1,523 of 4,120 patients (37.0%) in the omecamtiv mecarbil group and in 1,607 of 4,112 patients (39.1%) in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI] 0.86, 0.99; p=0.025). This effect was observed without evidence of an increase in the overall rates of myocardial ischemic events, ventricular arrhythmias or death from cardiovascular or all causes. No reduction in the secondary endpoint of time to CV death was observed and no other secondary endpoints were met in accordance with the prespecified statistical analysis. The effect of omecamtiv mecarbil was consistent across most prespecified subgroups and with a potentially greater treatment effect suggested in patients with a lower left ventricular ejection fraction (LVEF ≤28%, n=>4,000, hazard ratio, 0.84; 95% CI 0.77, 0.92; interaction p=0.003). A supplemental analysis of the continuous relationship between ejection fraction and the hazard ratio for the primary composite endpoint in GALACTIC-HF suggests a potentially stronger treatment effect of omecamtiv mecarbil in patients with increasingly lower ejection fractions.

Additional analyses of this lower ejection fraction subgroup in GALACTIC-HF showed that a potentially greater treatment effect in patients who received omecamtiv mecarbil was consistently observed in patients with characteristics that may indicate advanced heart failure status, such as being hospitalized within the last 3 months (HR 0.83, 95% CI 0.74 – 0.93, p=0.001), having New York Association Class III or IV heart failure (HR 0.80, 95% CI 0.71 – 0.90, p<0.001), higher N-terminal-pro brain natriuretic peptide levels (HR 0.77, 95% CI 0.69 – 0.87, p<0.001), and lower blood pressures (HR 0.81, 95% CI 0.70 – 0.92, p=0.002). Absolute risk reductions ranged from 5.2% to 8.1% in these subgroups vs. 2.1% in the overall population.

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