Cytokinetics, Incorporated (Nasdaq: CYTK) announced that Amgen Inc.
(“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.
About Omecamtiv
Mecarbil and the Phase 3 Clinical Trials
Program
Omecamtiv mecarbil is an investigational
selective cardiac myosin activator, the first of a novel class of
myotropes2 designed to directly target the contractile
mechanisms of the heart, binding to and recruiting more cardiac
myosin heads to interact with actin during systole. Preclinical
research showed omecamtiv mecarbil increases cardiac
contractility without increasing intracellular myocyte calcium
concentrations or myocardial oxygen consumption.3-5 Cardiac
myosin is the cytoskeletal motor protein in the cardiac muscle cell
responsible for converting chemical energy into the mechanical
force resulting in cardiac contraction.
Omecamtiv mecarbil is being developed for
the potential treatment of heart failure with reduced ejection
fraction (HFrEF). Omecamtiv mecarbil is the subject of a
comprehensive Phase 3 clinical trials program composed of
GALACTIC-HF and METEORIC-HF (Multicenter
Exercise Tolerance
Evaluation of Omecamtiv
Mecarbil Related to
Increased Contractility in
Heart Failure), a Phase 3
clinical trial designed to evaluate the effect of treatment
with omecamtiv mecarbil compared to placebo on exercise
capacity.
About Cytokinetics
Cytokinetics is a late-stage biopharmaceutical
company focused on discovering, developing and commercializing
first-in-class muscle activators and next-in-class muscle
inhibitors as potential treatments for debilitating diseases in
which muscle performance is compromised and/or declining. As a
leader in muscle biology and the mechanics of muscle performance,
the company is developing small molecule drug candidates
specifically engineered to impact muscle function and
contractility. Cytokinetics is preparing for regulatory
interactions for omecamtiv mecarbil, its novel cardiac muscle
activator, following positive results from GALACTIC-HF, a large,
international Phase 3 clinical trial in patients with heart
failure. Cytokinetics is conducting METEORIC-HF, a second Phase 3
clinical trial of omecamtiv mecarbil. Cytokinetics is also
developing CK-274, a next- generation cardiac myosin inhibitor, for
the potential treatment of hypertrophic cardiomyopathies (HCM).
Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of
CK-274 in patients with obstructive HCM. Cytokinetics is also
developing reldesemtiv, a fast skeletal muscle troponin activator
for the potential treatment of ALS and other neuromuscular
indications following conduct of FORTITUDE-ALS and other Phase 2
clinical trials. The company is considering potential advancement
of reldesemtiv to Phase 3 pending ongoing regulatory interactions.
Cytokinetics continues its over 20-year history of pioneering
innovation in muscle biology and related pharmacology focused to
diseases of muscle dysfunction and conditions of muscle
weakness.
For additional information about Cytokinetics,
visit www.cytokinetics.com and follow us on Twitter, LinkedIn,
Facebook and YouTube.
Forward-Looking Statements
This press release contains forward-looking
statements for purposes of the Private Securities Litigation Reform
Act of 1995 (the "Act"). Cytokinetics disclaims any
intent or obligation to update these forward-looking statements and
claims the protection of the Act's Safe Harbor for forward-looking
statements. Examples of such statements include, but are not
limited to, statements relating to the GALACTIC-HF clinical trial;
statements relating to the METEORIC-HF clinical trial;
Cytokinetics’ activities to advance the development of omecamtiv
mecarbil; the potential benefits of omecamtiv mecarbil,
including its ability to represent a novel therapeutic strategy to
increase cardiac muscle function and restore cardiac
performance; the potential approval of omecamtiv mecarbil by
the FDA or any other regulatory authority; the ability of
Cytokinetics to secure a co-commercialization partner for omecamtiv
mecarbil or to otherwise out-license omecamtiv mecarbil to a third
party; Amgen’s fulfillment of its undertakings regarding transition
of the omecamtiv mecarbil and AMG 594 programs to Cytokinetics;
Cytokinetics' and its partners' research and development
activities; the design, timing, results, significance and utility
of preclinical and clinical results; and the properties and
potential benefits of Cytokinetics' other drug
candidates. Such statements are based on management's current
expectations, but actual results may differ materially due to
various risks and uncertainties, including, but not limited to,
potential difficulties or delays in the development, testing,
regulatory approvals for trial commencement, progression or product
sale or manufacturing, or production
of Cytokinetics' drug candidates that could slow or
prevent clinical development or product
approval; Cytokinetics' drug candidates may have adverse
side effects or inadequate therapeutic efficacy; the FDA or foreign
regulatory agencies may delay or limit Cytokinetics' or
its partners' ability to conduct clinical
trials; Cytokinetics may be unable to obtain or maintain
patent or trade secret protection for its intellectual property;
the nature of Amgen's decisions and activities with respect to the
transfer of rights to develop and commercialize omecamtiv mecarbil
and AMG 594 to Cytokinetics; standards of care may change,
rendering Cytokinetics' drug candidates obsolete;
competitive products or alternative therapies may be developed by
others for the treatment of
indications Cytokinetics' drug candidates and potential
drug candidates may target; and risks and uncertainties relating to
the timing and receipt of payments from its partners, including
milestones and royalties on future potential product sales
under Cytokinetics' collaboration agreements with such
partners. For further information regarding these and other risks
related to Cytokinetics' business, investors should
consult Cytokinetics' filings with the Securities
and Exchange Commission.
Contact:CytokineticsDiane WeiserSenior Vice
President, Corporate Communications, Investor Relations(415)
290-7757
References
- Teerlink J et al. NEJM. 2020
- Psotka MA, Gottlieb SS, Francis GS et
al. Cardiac Calcitropes, Myotropes, and Mitotropes. JACC.
2019; 73:2345-53.
- Planelles-Herrero VJ, Hartman
JJ, Robert-Paganin J. et al. Mechanistic and structural basis
for activation of cardiac myosin force production by omecamtiv
mecarbil. Nat Commun. 2017;8:190.
- Shen YT, Malik FI, Zhao X, et al.
Improvement of cardiac function by a cardiac myosin activator in
conscious dogs with systolic heart failure. Circ Heart Fail.
2010; 3: 522-27.
- Malik FI, Hartman JJ, Elias KA, Morgan
BP, Rodriguez H, Brejc K, Anderson RL, Sueoka SH, Lee KH, Finer JT,
Sakowicz R. Cardiac myosin activation: a potential therapeutic
approach for systolic heart failure. Science. 2011 Mar
18;331(6023):1439-43.
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