Amgen (NASDAQ: AMGN), Cytokinetics, Incorporated (NASDAQ: CYTK) and
Servier today announced that the Data Monitoring Committee (DMC)
for GALACTIC-HF recently completed the first planned interim
analysis, which included consideration of pre-specified criteria
for futility. 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 futility analysis was triggered once a
pre-specified number of cardiovascular deaths had occurred in
GALACTIC-HF as stipulated by the trial’s protocol. The 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.
GALACTIC-HF opened to enrollment in late 2016
and is designed to enroll approximately 8,000 patients in over 35
countries who are either currently hospitalized for a primary
reason of heart failure or have had a hospitalization or admission
to an emergency room for heart failure within one year prior to
screening. The trial 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 cardiovascular (CV)
death in patients with chronic heart failure with reduced ejection
fraction. To date, over 7,000 patients have been enrolled in
GALACTIC-HF and completion of enrollment is expected in the first
half of 2019.
About Omecamtiv Mecarbil and the Phase 3
Clinical Trials ProgramOmecamtiv mecarbil is a novel,
selective cardiac myosin activator that binds to the catalytic
domain of myosin. Preclinical research has shown that cardiac
myosin activators increase cardiac contractility without affecting
intracellular myocyte calcium concentrations or myocardial oxygen
consumption.1-3 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
comprised of GALACTIC-HF (Global
Approach to Lowering
Adverse Cardiac Outcomes
Through Improving
Contractility in Heart
Failure), a large, Phase 3 global cardiovascular
outcomes study being conducted by Amgen in collaboration with
Cytokinetics and Servier, 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, being
conducted by Cytokinetics in collaboration with Amgen, with funding
and strategic support from Servier.
About Heart FailureHeart
failure is a grievous condition that affects more than 26 million
people worldwide4,5 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
CollaborationIn 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 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 Phase 3 clinical
trials program 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). Reldesemtiv has been granted orphan drug
designation by the FDA for the potential treatment of
spinal muscular atrophy. Reldesemtiv was the subject of a Phase 2
clinical study in patients with spinal muscular atrophy which
showed increases in measures of endurance and stamina consistent
with the mechanism of action. Reldesemtiv is currently the subject
of a Phase 2 clinical trial in patients with amyotrophic lateral
sclerosis. 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 4.2 billion euros in 2018,
Servier employs 22,000 people worldwide. Entirely independent, the
Group reinvests 25% of its turnover (excluding generics) 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.
Follow us on Social media:
LinkedIn, Facebook
Amgen Forward-Looking
StatementThis 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 estimates of revenues, operating margins, capital
expenditures, cash, other financial metrics, expected legal,
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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.
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to successfully market both new and existing products domestically
and internationally, clinical and regulatory developments involving
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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
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the protection offered by its patents and patent applications may
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Amgen may fail to prevail in present and future intellectual
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on supply may constrain sales of certain of its current products
and product candidate development. We rely on collaborations with
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and for the commercialization and sales of some of our commercial
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The scientific information discussed in this
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Cytokinetics Forward-Looking
StatementsThis 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 Cytokinetics’ and its partners’
research and development activities; the timing of enrollment of
patients in Cytokinetics’ and its partners’ clinical trials; 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; patient enrollment for or conduct
of clinical trials may be difficult or delayed; 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;
and Cytokinetics may be unable to obtain or maintain patent or
trade secret protection for its intellectual property; Astellas’
decisions with respect to the design, initiation, conduct, timing
and continuation of development activities for reldesemtiv; 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)Kristen Davis, 805-447-3008 (Media)Arvind Sood,
805-447-1060 (Investors)
CONTACT: Servier, media@servier.com
Sonia Marques, +33 (0)1 55 72 40 21 / + 33 (0) 7
84 28 76 13 Karine Bousseau, +33 (0)1 55 72 60 37 / + 33 (0)6 49 92
16 05
References1 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. 2 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.
3 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.
4 Savarese G and Lund LH. Global Public Health Burden of Heart
Failure. Cardiac Failure Review 2017;3 (1): 7-11.
5 Ponikowski P, Anker SD, AlHabib KF, et al. Heart failure:
preventing disease and death worldwide. ESC Heart Failure
2014;1:4–25.
6 Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA Guideline
for the Management of Heart failure: A Report of the American
College of Cardiology Foundation/American Heart Association Task
Force on Practice Guidelines. Circulation.
2013;128:e240-e327.
7 Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC guidelines
for the diagnosis and treatment of acute and chronic heart failure:
The Task Force for the diagnosis and treatment of acute and chronic
heart failure of the European Society of
Cardiology (ESC). Developed with the special contribution of
the Heart Failure Association (HFA) of the ESC. Eur
Heart J. 2016;37:2129–2200.
8 Roger VL. Epidemiology of Heart Failure. Circulation Research.
2013;113:646-659, originally published August 29, 2013. Doi:
10.1161/CIRCRESAHA.113.300268.
9 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.
10 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.
11 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.
12 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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