FDA Grants Amgen Priority Review Designation For Ivabradine For The Treatment Of Chronic Heart Failure

FDA Grants Amgen Priority Review Designation For Ivabradine For The Treatment
                           Of Chronic Heart Failure

PR Newswire

THOUSAND OAKS, Calif., Aug. 27, 2014

THOUSAND OAKS, Calif., Aug. 27, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN)
today announced the U.S. Food and Drug Administration (FDA) has granted
priority review designation for ivabradine for the treatment of chronic heart
failure (HF). Ivabradine is an oral drug that inhibits the I[f] current
("funny" current) in the sinoatrial node, the body's cardiac pacemaker.^1
Ivabradine works to slow the heart rate without negative effects on myocardial
contractility or ventricular repolarization.^1 Heart failure is a common
condition that affects approximately 26 million worldwide, including
approximately 5.1 million people in the U.S.^2,3

"The priority review designation by the FDA is evidence that chronic heart
failure is a serious condition, which leads to high rates of rehospitalization
and poor prognosis despite available treatments. If approved, ivabradine would
potentially provide a significant improvement, on top of standard-of-care
therapies, for this grievous condition," said Sean E. Harper, M.D., executive
vice president of Research and Development at Amgen. "We are excited about the
opportunity to bring this important therapeutic option to certain patients
with chronic heart failure in the U.S."

The New Drug Application (NDA) is based on global clinical trial data from the
Phase 3 SHIFT (Systolic Heart failure treatment with the I[f]inhibitor
ivabradine Trial) study, a large, multi-center, randomized, double-blind,
placebo-controlled, outcomes trial. The pivotal SHIFT study compared
ivabradine to placebo on top of standard-of-care therapies, including
beta-blockers, in more than 6,500 patients in sinus rhythm with reduced left
ventricular function and heart rate >70 beats per minute (bpm).

Priority review designation is assigned to applications for drugs that treat
serious conditions and would, if approved, provide significant improvements in
the safety or effectiveness of the treatment, diagnosis, or prevention of
serious conditions compared to available therapies. A priority review
designation will set a goal date for taking action on an application within
six months of receipt.^4

In addition, in April 2014, the FDA granted fast track designation for
ivabradine for patients with chronic HF. A fast track designation is a process
intended to facilitate the development and expedite the review of drugs to
treat serious conditions and fill an unmet medical need. Products that have
been designated as fast track can submit portions of a marketing application
before submitting the complete application, known as rolling review.^5

Heart failure is the leading cause of rehospitalization in Medicare
beneficiaries over age 55,^6 and approximately 50 percent of people diagnosed
with HF in the U.S. die within five years of diagnosis.^3 Projections show
that by 2030, the prevalence of HF will increase 25 percent from 2013
estimates.^3 Despite broad use of standard treatments, the prognosis for HF is
poor.^7

About Ivabradine
Ivabradine is an investigational oral drug that inhibits the I[f] current
("funny" current) in the sinoatrial node, the body's cardiac pacemaker.^1
Ivabradine works to slow the heart rate without negative effects on myocardial
contractility or ventricular repolarization.^1 Developed by Les Laboratoires
Servier, ivabradine was approved by the European Medicines Agency (EMA) as
PROCORALAN^® in 2005 for the symptomatic treatment of stable angina and in
2012 for chronic heart failure (HF) in patients with elevated heart rates.
Through a collaboration with Servier, Amgen has rights to commercialize
ivabradine in the U.S.

About Amgen's Commitment to Cardiovascular Disease
Amgen is dedicated to addressing important scientific questions in order to
advance care and improve the lives of patients with cardiovascular disease.
Through its own research and development efforts and innovative partnerships,
Amgen has built a robust cardiology pipeline consisting of several
investigational molecules in an effort to address a number of today's
important unmet patient needs, such as high cholesterol and heart failure.

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.

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
statements, including 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 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 (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 Aug. 27, 2014, 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 Amgen Inc. and its subsidiaries (which are collectively
referred to as we, or us) 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 and our partners to complete clinical trials and obtain
regulatory approval for product marketing has in the past varied and we expect
similar variability in the future. We develop 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 we may
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others could identify safety, side effects or manufacturing problems with our
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In addition, sales of our products (including products of our wholly-owned
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new products. We believe that some of our newer products, product candidates
or new indications for existing products, may face competition when and as
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have lower prices, established reimbursement, superior performance, are easier
to administer, or that are otherwise competitive with our products. In
addition, while we and our partners routinely obtain patents for products and
technology, the protection of our products offered by patents and patent
applications may be challenged, invalidated or circumvented by our competitors
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maintain patent protection for our products or product candidates. We cannot
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and savings from our recently announced restructuring plans. Our business
performance could affect or limit the ability of our Board of Directors to
declare a dividend or their ability to pay a dividend or repurchase our common
stock.

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.

CONTACT: Amgen
Kristen Davis, 805-447-3008 (media)
Arvind Sood, 805-447-1060 (investors)

References

1.DiFrancesco D and Camm JA. Heart Rate Lowering by Specific and Selective
    I(f) Current Inhibition With Ivabradine: a New Therapeutic Perspective in
    Cardiovascular Disease. Drugs. 2004;64(16):1757–1765.
2.López-Sendón, J. The Heart Failure Epidemic. MEDICOGRAPHIA.
    2011;33(4):363-369.
3.Go AS, Mozaffarian D, Roger VL, et al. Heart Disease and Stroke
    Statistics--2013 Update: A Report From the American Heart Association.
    Circ. 2013;127:e6-e245.
4.U.S. Food and Drug Administration. Center for Drug Evaluation and Research
    MAPP 6020.3.
    http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/manualofpoliciesprocedures/ucm082000.pdf.
    Accessed August 2014.
5.Food and Drug Administration. For Consumers: Fast Track, Breakthrough
    Therapy, Accelerated Approval and Priority Review. Available at:
    http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm.
    Accessed August 2014.
6.Jencks SF, Williams M, Coleman E. Rehospitalizations among Patients in the
    Medicare Fee-for-Service Program. NEJM. 2009;360:1418-28.
7.Swedberg K, Komajda M, Böhm M, et al. Ivabradine and Outcomes in Chronic
    Heart Failure (SHIFT): a Randomised Placebo Controlled Study. Lancet.
    2010;376:875-85.



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