Amgen (NASDAQ:AMGN), Cytokinetics, Incorporated (NASDAQ:CYTK) and
Servier today announced topline results from GALACTIC-HF, a Phase 3
pivotal clinical trial of omecamtiv mecarbil in patients with heart
failure with reduced ejection fraction (HFrEF).
The results of GALACTIC-HF show that treatment
with omecamtiv mecarbil achieved the primary composite efficacy
endpoint and demonstrated a statistically significant effect to
reduce 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 (HR: 0.92; 95% CI: 0.86, 0.99, p=0.0252).
No reduction in the secondary endpoint of CV
death was observed. Adverse events, including major ischemic
cardiac events, were balanced between treatment arms. Additional
analyses of data are underway and results from GALACTIC-HF will be
presented at the American Heart Association (AHA) Scientific
Sessions 2020, in a virtual Late Breaking Clinical Trial session on
Friday, November 13, 2020 from 10:35-10.45 a.m. CDT.
Omecamtiv mecarbil is an investigational cardiac
myosin activator, the first of a novel class of myotropes1 designed
to directly target the contractile mechanisms of the heart.
“The outcomes observed in GALACTIC-HF further
the understanding of treating heart failure, a devastating disease
in which half of heart failure patients will die within five years
of initial hospitalization,” said David M. Reese, M.D.
executive vice president of Research and Development at Amgen.
“At Amgen, we remain committed to developing and delivering
transformative medicines that improve the lives of patients with
cardiovascular disease.”
“GALACTIC-HF provides insights into effects
associated with targeting cardiac muscle contractility with
omecamtiv mecarbil to treat heart failure patients with reduced
ejection fraction,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’
executive vice president of Research & Development. “We are
grateful to the trial investigators, site personnel, patients and
caregivers who participated in the trial, and we look forward to
further data analyses and the presentation of the results of this
Phase 3 trial at the American Heart Association Scientific
Sessions.”
“Heart failure is a devastating condition
jeopardizing patients’ lives every day. We are pleased to have
collaborated with Amgen and Cytokinetics on one of the largest
heart failure trials ever conducted to investigate this novel
therapy in patients with heart failure. It is important to now turn
our attention to fully analyzing the data from this important study
in this clinical setting,” said Claude Bertrand, PharmD, PhD,
Executive Vice President R&D at Servier.
GALACTIC-HF: Trial Design
GALACTIC-HF,2 (Global Approach to
Lowering Adverse
Cardiac Outcomes Through
Improving Contractility in
Heart Failure), one of the
largest Phase 3 global cardiovascular outcomes studies in heart
failure ever conducted, enrolled 8,256 patients in 35 countries
with HFrEF, New York Heart Association (NYHA) class II-IV, left
ventricular ejection fraction (LVEF) ≤35%, elevated natriuretic
peptides and either current hospitalization for heart failure or
history of hospitalization or emergency department visit for heart
failure within a year. Patients were randomized to either oral
placebo or a starting dose of 25 mg omecamtiv mecarbil twice daily
(maintenance dose of 50 mg, 37.5 mg, or 25 mg twice daily) guided
by pharmacokinetic-guided dose selection. A blood test, the QMS
Omecamtiv Mecarbil Immunoassay (the OM Test) was used to measure
plasma levels of omecamtiv mecarbil in each patient in order to
guide selection of the appropriate maintenance dose.
The primary composite endpoint of this
double-blind, placebo-controlled, event-driven trial was time to CV
death or first heart failure event (heart failure hospitalization
and other urgent treatment for heart failure). Secondary endpoints
were: time to CV death, patient reported outcomes (measured by
Kansas City Cardiomyopathy Questionnaire [KCCQ] Total Symptom Score
[TSS]), time to first heart failure hospitalization and time to
all-cause death.
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 myotropes1 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 has shown that 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 that is directly 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) under a collaboration between Amgen and Cytokinetics, with
funding and strategic support from Servier. 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 Heart Failure Heart
failure is a grievous condition that affects more than 64 million
people worldwide6 about half of whom have reduced left ventricular
function.7,8 It is the leading cause of hospitalization and
readmission in people age 65 and older.9,10 Despite broad use of
standard treatments and advances in care, the prognosis for
patients with heart failure is poor.11 An estimated one in five
people over the age of 40 are at risk of developing heart failure,
and approximately 50 percent of people diagnosed with heart failure
will die within five years of initial hospitalization.12,13
About Cytokinetics and Amgen Collaboration In
2006, Cytokinetics and Amgen entered into a strategic alliance to
discover, develop and commercialize novel small molecule
therapeutics designed to activate the cardiac sarcomere for the
potential treatment of heart failure. Omecamtiv mecarbil is being
developed by Amgen in collaboration with Cytokinetics, with funding
and strategic support from Servier. Amgen holds an exclusive,
worldwide license to omecamtiv mecarbil and related compounds,
subject to Cytokinetics’ specified development and
commercialization rights. Cytokinetics is eligible for
pre-commercialization and commercialization milestone payments and
royalties that escalate based on increasing levels of annual net
sales of products commercialized under the agreement. Cytokinetics
has co-invested with Amgen in the Phase 3 development program of
omecamtiv mecarbil in exchange for increased royalties from Amgen
on worldwide sales of omecamtiv mecarbil outside Japan and
co-promotion rights in institutional care settings in North
America. Amgen has also entered an alliance with Servier for
exclusive commercialization rights for omecamtiv mecarbil 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 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 biologics manufacturing 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 the world’s largest independent biotechnology company, has
reached millions of patients around the world and is developing a
pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and
follow us on www.twitter.com/amgen.
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 collaborating with Amgen Inc.
(Amgen) to develop omecamtiv mecarbil, a novel cardiac muscle
activator. Omecamtiv mecarbil is the subject of an international
clinical trials program in patients with heart failure including
GALACTIC-HF and METEORIC-HF. Amgen holds an exclusive worldwide
license to develop and commercialize omecamtiv mecarbil with a
sublicense held by Servier for commercialization in Europe and
certain other countries. Cytokinetics is developing reldesemtiv, a
fast skeletal muscle troponin activator (FSTA) 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 is
collaborating with Astellas Pharma Inc. (Astellas) to research,
develop and commercialize other novel mechanism skeletal sarcomere
activators (not including FSTAs). Licenses held by Amgen and
Astellas are subject to specified co-development and
co-commercialization rights of Cytokinetics. Cytokinetics is also
developing CK-274, a novel cardiac myosin inhibitor that company
scientists discovered independent of its collaborations, for the
potential treatment of hypertrophic cardiomyopathies. Cytokinetics
has granted Ji Xing Pharmaceuticals Limited an exclusive license to
develop and commercialize CK-274 in China and Taiwan, in accordance
with Cytokinetics’ planned global registration programs.
Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of
CK-274 in patients with obstructive HCM. 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.
About Servier Servier is an
international pharmaceutical company governed by a non-profit
foundation, with its headquarters in France (Suresnes). With a
strong international presence in 150 countries and a turnover of
4.6 billion euros in 2019, Servier employs 22,000 people worldwide.
Entirely independent, the Group reinvests in average 25% of its
turnover (excluding generics) every year in research and
development and uses all its profits for development. Corporate
growth is driven by Servier’s constant commitment in five areas of
excellence: cardiovascular, immune-inflammatory and
neurodegenerative diseases, cancer and diabetes, as well as by its
activities in high-quality generic drugs. Servier also offers
eHealth solutions beyond drug development. More information:
www.servier.com
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Otezla® (apremilast) acquisition, including anticipated Otezla
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and uncertainties, including those discussed below and more fully
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candidates. Cytokinetics 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 GALACTIC-HF; 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 approval of omecamtiv mecarbil
by the FDA or any other regulatory agency; the successful marketing
and commercialization of omecamtiv mecarbil; Cytokinetics’ and its
partners’ research and development activities; the design, timing,
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candidates that could slow or prevent clinical development or
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research and development activities and business operations,
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inadequate therapeutic efficacy; the FDA or foreign regulatory
agencies may delay or limit Cytokinetics’ or its partners’ ability
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maintain patent or trade secret protection for its intellectual
property; Amgen’s decisions with respect to the design, initiation,
conduct, timing and continuation of development activities for
omecamtiv mecarbil; standards of care may change, rendering
Cytokinetics’ drug candidates obsolete; competitive products or
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CONTACT: Amgen, Thousand Oaks Trish Rowland,
805-447-5631 (media) Jessica Akopyan, 805-447-0974 (media) Arvind
Sood, 805-447-1060 (investors)
CONTACT: Cytokinetics Diane Weiser, Senior Vice
President, Corporate Communications, Investor Relations
415-290-7757
CONTACT: Servier Sonia Marques:
sonia.marques@servier.com – Tel. +33 (0)1 55 72 40 21 / + 33 (0) 7
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– Tel. +33 (0)1 55 72 46 16 / + 33 (0) 6 79 56 75 96
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