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 ProgramOmecamtiv 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 FailureHeart
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 CytokineticsCytokinetics
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
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, 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, partnerships and joint
ventures. Product candidates that are derived from relationships
may be subject to disputes between the parties or may prove to be
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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
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and internationally, clinical and regulatory developments involving
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and domestic and international trends toward managed care and
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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. An outbreak
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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,
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class of products could have a material adverse effect on sales of
the affected products and on its business and results of
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Amgen’s stock price may be volatile and may be affected by a number
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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; 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 OaksMegan Fox,
805-447-1423 (media)Trish Rowland, 805-447-5631 (media) Arvind
Sood, 805-447-1060 (investors)
References
- Psotka MA, Gottlieb SS, Francis GS et al. Cardiac
Calcitropes, Myotropes, and Mitotropes. JACC. 2019;
73:2345-53.
- 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.
- 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.
- 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.
- GBD 2017 Disease and Injury Incidence and Prevalence
Collaborators. Lancet 2018; 392: 1789–858.
- 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.
- 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.
- 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, Muntner P, Alonso A. et al. Heart Disease and
Stroke Statistics—2019 Update: A Report From the American Heart
Association. Circulation. 2019;139:e56-e528.
- 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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