THOUSAND OAKS, Calif.
and SOUTH SAN FRANCISCO,
Calif., May 8, 2020
/PRNewswire/ -- Amgen (NASDAQ:AMGN) and Cytokinetics, Incorporated
(NASDAQ:CYTK) today announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation for
omecamtiv mecarbil, a novel selective cardiac myosin activator,
also known as a cardiac myotrope,1 being developed for
the potential treatment of chronic heart failure with reduced
ejection fraction (HFrEF).
Fast Track designation may potentially expedite the review of a
drug that is intended for the treatment of a serious or
life-threatening disease or condition and demonstrates the
potential to address an unmet medical need for such a disease or
condition.
"This Fast Track designation represents an important milestone
in the development of omecamtiv mecarbil," said David M.
Reese, M.D., executive vice president of Research and Development
at Amgen. "Today, half of heart failure patients will die
within five years of diagnosis, underscoring the urgent need for
new therapies for this grievous condition."
"We are pleased that the FDA has granted Fast Track designation
for omecamtiv mecarbil for the potential treatment of heart
failure," said Robert I. Blum,
president and chief executive officer of Cytokinetics. "The
prevalence of heart failure is growing with our aging demographics,
and GALACTIC-HF is designed to assess the clinical effects of our
novel myosin activator in patients meaningfully at risk."
GALACTIC-HF (Global Approach to Lowering
Adverse Cardiac Outcomes Through
Improving Contractility in Heart
Failure), one of the largest Phase 3 global cardiovascular
(CV) outcomes studies in heart failure ever conducted, 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 HFrEF. GALACTIC-HF
enrolled 8,256 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. Dose selection for omecamtiv mecarbil in this study
uses a blood test. Top-line results from GALACTIC-HF are expected
in Q4 2020.
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,1 that binds to the catalytic domain of myosin.
Preclinical research has shown that omecamtiv mecarbil increases
cardiac contractility without increasing intracellular myocyte
calcium concentrations or myocardial oxygen consumption. 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.
2-4
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 (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
CV 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
worldwide5 about half of whom have reduced left
ventricular function.6,7 It is the leading cause of
hospitalization and readmission in people age 65 and
older.8,9 Despite broad use of standard treatments and
advances in care, the prognosis for patients with heart failure is
poor.10 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.11,12
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
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.
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, or potential
collaborations, with any other company, including Adaptive
Biotechnologies (including statements regarding such
collaboration's ability to discover and develop fully human
neutralizing antibodies targeting SARS-CoV-2 to potentially prevent
or treat COVID-19), 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, effects of pandemics or other widespread health problems
such as the ongoing COVID-19 pandemic on our business, outcomes,
progress, or effects relating to studies of Otezla as a potential
treatment for COVID-19, 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,
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derived from relationships may be subject to disputes between the
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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
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current and future products, sales growth of recently launched
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difficulties or delays in manufacturing its products and global
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and domestic and international trends toward managed care and
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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. An outbreak of disease or similar public
health threat, such as COVID-19, and the public and governmental
effort to mitigate against the spread of such disease, could have a
significant adverse effect on the supply of materials for Amgen's
manufacturing activities, the distribution of Amgen's products, the
commercialization of Amgen's product candidates, and Amgen's
clinical trial operations, and any such events may have a material
adverse effect on Amgen's product development, product sales,
business and results of operations. 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
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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
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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; 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; the
impact of the COVID-19 pandemic on our research and development
activities and business operations, 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, Senior Vice President,
Corporate Communications, Investor Relations
415-290-7757
CONTACT: Amgen, Thousand
Oaks
Megan Fox, 805-447-1423 (media)
Trish Rowland, 805-447-5631
(media)
Arvind Sood, 805-447-1060
(investors)
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SOURCE Amgen