Amgen And Cytokinetics Announce The First Presentation Of Data From Phase 2 ATOMIC-AHF Study Of Omecamtiv Mecarbil

 Amgen And Cytokinetics Announce The First Presentation Of Data From Phase 2
                    ATOMIC-AHF Study Of Omecamtiv Mecarbil

First Trial to Evaluate Cardiac Myosin Activator in Patients with Acute Heart
Failure Presented at ESC Congress 2013

PR Newswire

THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Sept. 3, 2013

THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Sept. 3, 2013
/PRNewswire/ -- Amgen (NASDAQ: AMGN) and Cytokinetics Incorporated (NASDAQ:
CYTK) today announced the first presentation of data from the ATOMIC-AHF
(Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in Acute
Heart Failure) study at the ESC Congress 2013, organized by the European
Society of Cardiology, in Amsterdam. ATOMIC-AHF was a randomized,
double-blind, placebo-controlled Phase 2 study that enrolled 613 patients
hospitalized with acute heart failure (AHF) treated for 48 hours with
omecamtiv mecarbil or placebo and designed to evaluate the safety,
pharmacokinetics, pharmacodynamics, and potential efficacy of an intravenous
formulation of omecamtiv mecarbil in patients with AHF. The study did not meet
its primary endpoint of dyspnea (shortness of breath) response as measured by
the 7-point Likert scale through 48 hours (p=0.33) but showed favorable dose
and concentration-related trends on dyspnea response.

ATOMIC-AHF enrolled three, sequential, dose escalation cohorts of patients
treated for 48 hours with omecamtiv mecarbil or placebo. The primary efficacy
endpoint in ATOMIC-AHF was dyspnea symptom response. Secondary endpoints
included other clinical and pharmacodynamic (echocardiographic) effects
including death or worsening heart failure within seven days. The omecamtiv
mecarbil treatment groups were not statistically different in their 7-point
Likert scale dyspnea symptom response rates compared to the pooled placebo
group (p=0.33); therefore, the primary endpoint was not met. Omecamtiv
mecarbil demonstrated favorable dose- and concentration-related trends
(nominal p=0.025 and nominal p=0.007, respectively) on dyspnea response.
Improvement in dyspnea was observed in the highest omecamtiv mecarbil dose
group when compared against its paired placebo group in the third cohort
(dyspnea symptom response in 51 percent of subjects on omecamtiv mecarbil
versus 37 percent on placebo, nominal p=0.03). The incidence of worsening
heart failure within seven days of initiating treatment was 17 percent in the
pooled placebo group and was 13 percent, 8 percent and 9 percent on omecamtiv
mecarbil in the first, second and third cohorts, respectively. Systolic
ejection time, the echocardiographic signature of omecamtiv mecarbil,
increased in a concentration-dependent manner.

Rates of adverse events (AEs), serious AEs, adjudicated deaths and
hospitalizations were similar between omecamtiv mecarbil and placebo groups.
There were seven post-randomization myocardial infarctions in the omecamtiv
mecarbil treated groups compared with three in the placebo groups (2.3 percent
vs. 1.0 percent, respectively). However, there was no relationship between the
maximum increase from the baseline troponin (a biomarker specific for cardiac
muscle damage) and increasing plasma concentrations of omecamtiv mecarbil.
Omecamtiv mecarbil was not associated with an increased incidence of
tachyarrhythmias nor were heart rate or blood pressure adversely affected.

"Although ATOMIC-AHF did not achieve its primary efficacy endpoint, we are
encouraged by the data from this study," said Sean E. Harper, M.D., executive
vice president of Research and Development at Amgen. "Omecamtiv mecarbil is a
unique investigational therapy for patients with acute and chronic heart
failure. We look forward to the data from the COSMIC-HF study, which together
with the data from ATOMIC-AHF will inform our decision on whether to progress
omecamtiv mecarbil into Phase 3 clinical trials."

"We are pleased with the results from ATOMIC-AHF,"  stated Robert I. Blum,
President and CEO at Cytokinetics. "This novel mechanism drug candidate has
consistently been associated with dose-related and plasma
concentration-related pharmacodynamic and other effects in a robust program of
Phase 1 and Phase 2 clinical trials. We look forward to results from COSMIC-HF
and the potential progression of omecamtiv mecarbil in development."

ATOMIC-AHF and COSMIC-HF
ATOMIC-AHF is a completed Phase 2 clinical trial designed to evaluate an
intravenous formulation of omecamtiv mecarbil in 613 patients enrolled in
three sequential, ascending-dose cohorts. In each cohort, patients were
randomized 1:1 to omecamtiv mecarbil or placebo. The primary objective of this
trial was to evaluate the effect of 48 hours of intravenous omecamtiv mecarbil
compared to placebo on dyspnea in patients with left ventricular systolic
dysfunction hospitalized for acute heart failure. The secondary objectives
were to assess the safety and tolerability of the three dose levels of
omecamtiv mecarbil compared with placebo and to evaluate the effects of 48
hours of treatment with intravenous omecamtiv mecarbil on additional clinical
and pharmacodynamic measures.

Oral formulations of omecamtiv mecarbil are currently being evaluated in a
Phase 2 trial known as COSMIC-HF (Chronic Oral Study of Myosin Activation to
Increase Contractility in Heart Failure). COSMIC-HF is a double-blind,
randomized, placebo-controlled, multicenter, dose escalation study designed to
evaluate the safety and efficacy of omecamtiv mecarbil in approximately 420
patients with chronic heart failure and left ventricular systolic dysfunction.

ATOMIC-AHF and COSMIC-HF are clinical trials of omecamtiv mecarbil conducted
by Amgen in collaboration with Cytokinetics. Amgen holds an exclusive,
worldwide license to develop and commercialize omecamtiv mecarbil and related
compounds, subject to Cytokinetics' specified development and
commercialization participation rights.

Additional information about clinical trials of omecamtiv mecarbil can be
found at www.clinicaltrials.gov.

About Omecamtiv Mecarbil
Omecamtiv mecarbil is a novel cardiac myosin activator and is the subject of a
collaboration between Cytokinetics and Amgen. 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. Cardiac myosin activators are thought to accelerate
the rate-limiting step of the myosin enzymatic cycle and shift the enzymatic
cycle in favor of the force-producing state. Preclinical research has shown
that cardiac myosin activators increase contractility in the absence of
changes in intracellular calcium in cardiac myocytes.

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 clinical-stage biopharmaceutical company focused on the
discovery and development of novel small molecule therapeutics that modulate
muscle function for the potential treatment of serious diseases and medical
conditions. Cytokinetics' lead drug candidate from its cardiac muscle
contractility program, omecamtiv mecarbil, is in Phase II clinical development
for the potential treatment of heart failure. Amgen Inc. holds an exclusive
license worldwide to develop and commercialize omecamtiv mecarbil and related
compounds, subject to Cytokinetics' specified development and
commercialization participation rights.

Cytokinetics is independently developing tirasemtiv, a fast skeletal muscle
activator, as a potential treatment for diseases and medical conditions
associated with neuromuscular dysfunction. Cytokinetics is collaborating with
Astellas Pharma Inc. to develop CK-2127107, a skeletal muscle activator
structurally distinct from tirasemtiv, for non-neuromuscular indications. All
of these drug candidates have arisen from Cytokinetics' muscle biology focused
research activities and are directed towards the cytoskeleton. The
cytoskeleton is a complex biological infrastructure that plays a fundamental
role within every human cell.

Additional information about Cytokinetics can be obtained at
www.cytokinetics.com

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on
management's current expectations and beliefs and are subject to a number of
risks, uncertainties and assumptions that could cause actual results to differ
materially from those described. All statements, other than statements of
historical fact, are statements that could be deemed forward-looking
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other such estimates and results. Forward-looking statements involve
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fully described in the Securities and Exchange Commission (SEC) reports filed
by Amgen, including Amgen's most recent annual report on Form 10-K and any
subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's
most recent Forms 10-K, 10-Q and 8-K for additional information on the
uncertainties and risk factors related to our business. Unless otherwise
noted, Amgen is providing this information as of Sept. 2, 2013, and expressly
disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ
materially from those we project. 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 us to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and we expect similar variability in
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In addition, sales of our products are affected by the reimbursement policies
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or new indications for existing products, may face competition when and as
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addition, while we routinely obtain patents for our products and technology,
the protection offered by our patents and patent applications may be
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produce commercially successful products or maintain the commercial success of
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of products could have a material adverse effect on sales of the affected
products and on our business and results of operations.

The scientific information discussed in this news release related to our
product candidates is preliminary and investigative. Such product candidates
are not approved by the U.S. Food and Drug Administration (FDA), 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 Cytokinetics' and Amgen's research and development
activities, including the conduct and design of clinical trials; the
significance and utility of clinical trial results; and the properties and
potential benefits of omecamtiv mecarbil and Cytokinetics' other 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: Cytokinetics anticipates that it
will be required to conduct at least one confirmatory Phase III clinical trial
of tirasemtiv in ALS patients which will require significant additional
funding, and it may be unable to obtain such additional funding on acceptable
terms, if at all; 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, including
risks that current and past results of clinical trials or preclinical studies
may not be indicative of future clinical trials results, 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 U.S. Food and Drug Administration 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; Amgen's and Astellas'
decisions with respect to the design, initiation, conduct, timing and
continuation of development activities for omecamtiv mecarbil and CK-2127107,
respectively; Cytokinetics may incur unanticipated research and development
and other costs or be unable to obtain additional financing necessary to
conduct development of its products; Cytokinetics may be unable to enter into
future collaboration agreements for its drug candidates and programs on
acceptable terms, if at all; 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.

CONTACTS:

Amgen, Thousand Oaks
Ashleigh Koss, 805-559-0746 (media)
Arvind Sood, 805-447-1060 (investors)

Cytokinetics, Inc., South San Francisco
Joanna L. Goldstein, 650-624-3000 (investors and media)

(Logo: http://photos.prnewswire.com/prnh/20081015/AMGENLOGO)

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SOURCE Amgen

Website: http://www.amgen.com
Website: http://www.cytokinetics.com
 
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