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 ProgramOmecamtiv 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 FailureHeart
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
AmgenAmgen 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 CytokineticsCytokinetics
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
ServierServier 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
StatementsThis 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
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estimates of revenues, operating margins, capital expenditures,
cash, other financial metrics, expected legal, arbitration,
political, regulatory or clinical results or practices, customer
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outcomes and other such estimates and results. Forward-looking
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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
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update any forward-looking statements contained in this document as
a result of new information, future events or otherwise.
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and actual results may differ materially from those Amgen projects.
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development of new indications for existing products cannot be
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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
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and through licensing collaborations, partnerships and joint
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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
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component parts for Amgen’s products are supplied by sole
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and payers have substantial purchasing leverage in their dealings
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similar to one of Amgen’s products that implicate an entire class
of products could have a material adverse effect on sales of the
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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 OaksJessica Akopyan,
805-447-0974 (media)Megan Fox, 805-447-1423 (media)Trish Rowland,
805-447-5631 (media) Arvind Sood, 805-447-1060 (investors)
CONTACT: ServierSonia Marques: sonia.marques@servier.com – Tel.
+33 (0)1 55 72 40 21 / + 33 (0) 7 84 28 76 13Jean-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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Chronic Heart Failure With Reduced Ejection Fraction:
Rationale and Design of GALACTIC-HF. J Am Coll Cardiol
HF. 2020 Feb
05. Epublished DOI:10.1016/j.jchf.2019.12.001
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Calcitropes, Myotropes, and Mitotropes. JACC. 2019;
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K, Anderson RL, Sueoka SH, Lee KH, Finer JT, Sakowicz R. Cardiac
myosin activation: a potential therapeutic approach for systolic
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- Ponikowski P, Voors AA, Anker SD, et al. 2016
ESC guidelines for the diagnosis and treatment of acute and chronic
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the Heart Failure Association (HFA) of the ESC. Eur
Heart J. 2016;37:2129–2200.
- Roger VL. Epidemiology of Heart Failure. Circulation
Research. 2013;113:646-659, originally published August 29,
2013. Doi: 10.1161/CIRCRESAHA.113.300268.
- Kilgore M, Patel HK, Kielhorn A et al. Economic burden of
hospitalizations of Medicare beneficiaries with heart
failure. Risk Manag Healthc Policy. 2017; 10:
63-70.
- Jhund PS, MacIntyre K, Simpson CR, et al. Long-Term Trends in
First Hospitalization for Heart Failure and Subsequent Survival
Between 1986 and 2003. Circulation. 2009;119:515-523.
- Benjamin EJ, Virani SS, Callaway CW et al. Heart Disease and
Stroke Statistics—2018 Update: A Report From the American
Heart Association. Circulation. 2018;137:e67-e492.
- Rogers VL, Weston SA, Redfield MM, et al. Trends in Heart
Failure Incidence and Survival in a Community-Based
Population. JAMA. 2004;292:344-350.
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