THOUSAND OAKS, Calif.,
SOUTH SAN FRANCISCO, Calif.,
and SURESNES, France, Feb. 26,
2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN), Cytokinetics,
Incorporated (NASDAQ:CYTK) and Servier today announced that the
Data Monitoring Committee (DMC) for GALACTIC-HF recently completed
the second and final planned interim analysis, which included
consideration of pre-specified criteria for futility and
superiority. The DMC reviewed data from GALACTIC-HF and recommended
that this Phase 3 clinical trial of omecamtiv mecarbil continue
without changes to its conduct.
The second interim analysis was triggered once a pre-specified
number of cardiovascular deaths had occurred in GALACTIC-HF as
stipulated by the trial's protocol. A futility analysis allowed the
potential for stopping GALACTIC-HF early had the interim analysis
shown a low likelihood of the trial demonstrating a clinically
meaningful and statistically significant benefit on the primary
endpoint in patients receiving omecamtiv mecarbil, plus
standard of care, compared to patients receiving placebo
plus standard of care. A superiority analysis allowed the potential
for stopping the trial early if the primary composite endpoint and
the secondary endpoint (time to cardiovascular death) reached
statistical significance, adjusting the statistical threshold for
interim review.1 The DMC considers all available
evidence in its recommendations regarding trial conduct, and the
stopping boundaries provide guidance to the DMC but are not binding
rules.
GALACTIC-HF, one of the largest Phase 3 global cardiovascular
outcomes studies in heart failure ever conducted, has now completed
enrollment of more than 8,200 patients in 35 countries who were
either hospitalized at the time of enrollment for a primary reason
of heart failure, or had a hospitalization or admission to an
emergency room for heart failure within one year prior to
screening. It is designed to evaluate whether treatment with
omecamtiv mecarbil, when added to standard of care, reduces the
risk of heart failure events (heart failure hospitalization and
other urgent treatment for heart failure) and CV death in patients
with heart failure with reduced ejection fraction (HFrEF).
About Omecamtiv Mecarbil and the Phase 3 Clinical Trials
Program
Omecamtiv mecarbil is a novel, selective
cardiac myosin activator, also known as a cardiac
myotrope,2 that binds to the catalytic domain of myosin.
Preclinical research has shown that cardiac myotropes increase
cardiac contractility without affecting 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 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 (Global Approach to Lowering
Adverse Cardiac Outcomes Through
Improving Contractility in Heart
Failure), a Phase 3 clinical trial designed to evaluate the
effect of treatment with omecamtiv mecarbil compared to placebo on
cardiovascular outcomes 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 best-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 collaborating with Astellas Pharma Inc. (Astellas)
to develop reldesemtiv, a fast skeletal muscle troponin activator
(FSTA). Astellas holds an exclusive worldwide license to develop
and commercialize reldesemtiv. 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 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 149 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 search for innovation 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
Amgen Forward-Looking Statements
This news release
contains forward-looking statements that are based on the current
expectations and beliefs of Amgen. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including any statements on the
outcome, benefits and synergies of collaborations with any other
company, including BeiGene, Ltd., or the Otezla®
(apremilast) acquisition, including anticipated Otezla sales growth
and the timing of non-GAAP EPS accretion, as well as estimates of
revenues, operating margins, capital expenditures, cash, other
financial metrics, expected legal, arbitration, political,
regulatory or clinical results or practices, customer and
prescriber patterns or practices, reimbursement activities and
outcomes and other such estimates and results. Forward-looking
statements involve significant risks and uncertainties, including
those discussed below and more fully described in the Securities
and Exchange Commission reports filed by Amgen, including its most
recent annual report on Form 10-K and any subsequent periodic
reports on Form 10-Q and current reports on Form 8-K. Unless
otherwise noted, Amgen is providing this information as of the date
of this news release and does not undertake any obligation to
update any forward-looking statements contained in this document as
a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those Amgen projects. Discovery
or identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, preclinical results do not
guarantee safe and effective performance of product candidates in
humans. The complexity of the human body cannot be perfectly, or
sometimes, even adequately modeled by computer or cell culture
systems or animal models. The length of time that it takes for
Amgen to complete clinical trials and obtain regulatory approval
for product marketing has in the past varied and Amgen expects
similar variability in the future. Even when clinical trials are
successful, regulatory authorities may question the sufficiency for
approval of the trial endpoints Amgen has selected. Amgen develops
product candidates internally and through licensing collaborations,
partnerships and joint ventures. Product candidates that are
derived from relationships may be subject to disputes between the
parties or may prove to be not as effective or as safe as Amgen may
have believed at the time of entering into such relationship. Also,
Amgen or others could identify safety, side effects or
manufacturing problems with its products, including its devices,
after they are on the market.
Amgen's results may be affected by its ability to successfully
market both new and existing products domestically and
internationally, clinical and regulatory developments involving
current and future products, sales growth of recently launched
products, competition from other products including biosimilars,
difficulties or delays in manufacturing its products and global
economic conditions. In addition, sales of Amgen's products are
affected by pricing pressure, political and public scrutiny and
reimbursement policies imposed by third-party payers, including
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
healthcare cost containment. Furthermore, Amgen's research,
testing, pricing, marketing and other operations are subject to
extensive regulation by domestic and foreign government regulatory
authorities. Amgen's business may be impacted by government
investigations, litigation and product liability claims. In
addition, Amgen's business may be impacted by the adoption of new
tax legislation or exposure to additional tax liabilities. If Amgen
fails to meet the compliance obligations in the corporate integrity
agreement between Amgen and the U.S. government, Amgen could become
subject to significant sanctions. Further, while Amgen routinely
obtains patents for its products and technology, the protection
offered by its patents and patent applications may be challenged,
invalidated or circumvented by its competitors, or Amgen may fail
to prevail in present and future intellectual property litigation.
Amgen performs a substantial amount of its commercial manufacturing
activities at a few key facilities, including in Puerto Rico, and also depends on third parties
for a portion of its manufacturing activities, and limits on supply
may constrain sales of certain of its current products and product
candidate development. Amgen relies on collaborations with third
parties for the development of some of its product candidates and
for the commercialization and sales of some of its commercial
products. In addition, Amgen competes with other companies with
respect to many of its marketed products as well as for the
discovery and development of new products. Further, some raw
materials, medical devices and component parts for Amgen's products
are supplied by sole third-party suppliers. Certain of Amgen's
distributors, customers and payers have substantial purchasing
leverage in their dealings with Amgen. The discovery of significant
problems with a product similar to one of Amgen's products that
implicate an entire class of products could have a material adverse
effect on sales of the affected products and on its business and
results of operations. Amgen's efforts to collaborate with or
acquire other companies, products or technology, and to integrate
the operations of companies or to support the products or
technology Amgen has acquired, may not be successful. A breakdown,
cyberattack or information security breach could compromise the
confidentiality, integrity and availability of Amgen's systems and
Amgen's data. Amgen's stock price may be volatile and may be
affected by a number of events. Amgen's business performance could
affect or limit the ability of the Amgen Board of Directors to
declare a dividend or its ability to pay a dividend or repurchase
its common stock. Amgen may not be able to access the capital and
credit markets on terms that are favorable to it, or at all.
The scientific information discussed in this news release
related to Amgen's product candidates is preliminary and
investigative. Such product candidates are not approved by the U.S.
Food and Drug Administration, and no conclusions can or should be
drawn regarding the safety or effectiveness of the product
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, including the planned timing of a second interim
analysis for superiority; the potential benefits of omecamtiv
mecarbil, including its ability to represent a novel therapeutic
strategy to increase cardiac muscle function and restore cardiac
performance; 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' 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; 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
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: Cytokinetics
Diane Weiser, Vice President,
Corporate Communications, Investor Relations
415-290-7757
CONTACT: Amgen, Thousand
Oaks
Jessica Akopyan, 805-447-0974 (media)
Megan Fox, 805-447-1423 (media)
Trish Rowland, 805-447-5631
(media)
Arvind Sood, 805-447-1060
(investors)
CONTACT: Servier
Sonia Marques:
sonia.marques@servier.com
– Tel. +33 (0)1 55 72 40 21 / + 33 (0) 7 84 28 76 13
Jean-Clément Vergeau: jean-clement.vergeau@servier.com
– Tel. +33 (0)1 55 72 46 16 / + 33 (0) 6 79 56 75 96
References
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05. Epublished DOI:10.1016/j.jchf.2019.12.001
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- Jhund PS, MacIntyre K, Simpson CR, et al. Long-Term Trends in
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SOURCE Amgen