THOUSAND OAKS, Calif.,
March 20, 2015 /PRNewswire/ -- Amgen
(NASDAQ: AMGN) today announced that an application seeking
marketing approval of RepathaTM (evolocumab) for the
treatment of high cholesterol has been submitted for review to the
Ministry of Health, Labour and Welfare in Japan. Repatha is being developed in
Japan by Amgen Astellas BioPharma
K.K., a joint venture between Amgen and Astellas Pharma Inc., a
pharmaceutical company headquartered in Tokyo.
Repatha is an investigational fully human monoclonal antibody
that inhibits proprotein convertase subtilisin/kexin type 9
(PCSK9), a protein that reduces the liver's ability to remove
low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol,
from the blood.1 In Japan, LDL-C levels are not
adequately controlled for many patients taking statins, nearly half
of whom have not reached their LDL-C goal.2,3
"Submitting Repatha for marketing approval in Japan is an important milestone in our
strategic partnership alliance with Astellas Pharma as we look
forward to accomplishing our common goal of addressing the critical
needs of patients with high cholesterol," said Sean E. Harper, M.D., executive vice president
of Research and Development at Amgen. "We look forward to working
with regulatory authorities in Japan to provide a new treatment option for
patients whose cholesterol is uncontrolled with currently available
therapies."
The Japanese New Drug Application for marketing approval for
Repatha contains data from approximately 7,200 patients with high
cholesterol in 11 Phase 3 trials, including Japanese patients from
studies conducted in Japan. Overall, the Phase 3 studies
evaluated the safety and efficacy of Repatha in patients with
elevated cholesterol on statins with or without other
lipid-lowering therapies; patients who cannot tolerate statins;
patients with heterozygous familial hypercholesterolemia (HeFH);
and patients with homozygous familial hypercholesterolemia (HoFH),
a rare and serious genetic disorder.4
In the U.S., Amgen submitted a Biologics License Application for
Repatha for the treatment of high cholesterol to the Food and Drug
Administration (FDA) in August 2014.
The FDA's Prescription Drug User Fee Act target action date is
Aug. 27, 2015. In the European Union,
Amgen submitted a Marketing Authorization Application to the
European Medicines Agency via the centralized procedure for Repatha
for the treatment of high cholesterol in September 2014.
High cholesterol is the most common form of dyslipidemia, which
is an abnormality of cholesterol and/or fats in the
blood.5,6 There are approximately 300 million cases of
dyslipidemia in the U.S., Japan and Western Europe.7
Familial hypercholesterolemia (FH) is an inherited condition
caused by genetic mutations which lead to high levels of LDL-C at
an early age,4 and it is estimated that less than one
percent of people with FH (heterozygous and homozygous forms) in
Japan are diagnosed.8
Patients can have either one of two types of FH.4
Heterozygous FH is the more common type of FH and in Japan, occurs in approximately one in 900
individuals.8,9 It can cause LDL-C levels twice as high
as normal (e.g., >190 mg/dL).10 Individuals with HeFH
have one altered copy of a cholesterol-regulating
gene.10 Homozygous FH is the rare, more severe form,
occurring in approximately one in a million
individuals.11 It can cause LDL-C levels more than six
times as high as normal (e.g., 500-1,000 mg/dL).12,13 An
individual with HoFH has two altered copies of
cholesterol-regulating genes (one from each
parent).4
About RepathaTM
(evolocumab)
RepathaTM (evolocumab) is a fully
human monoclonal antibody that inhibits proprotein convertase
subtilisin/kexin type 9 (PCSK9).1 PCSK9 is a protein
that targets LDL receptors for degradation and thereby reduces the
liver's ability to remove LDL-C, or "bad" cholesterol, from the
blood.14 Repatha, being developed by Amgen scientists,
is designed to bind to PCSK9 and inhibit PCSK9 from binding to LDL
receptors on the liver surface. In the absence of PCSK9, there are
more LDL receptors on the surface of the liver to remove LDL-C from
the blood.1
The trademark Repatha has been filed and is registered in
Japan. The FDA has provisionally approved the trade name
Repatha.
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 one of the
world's leading independent biotechnology companies, 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
March 20, 2015, 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 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 have believed at the time of
entering into such relationship. Also, we or others could identify
safety, side effects or manufacturing problems with our products
after they are on the market. Our business may be impacted by
government investigations, litigation and products liability
claims. We depend on third parties for a significant portion of our
manufacturing capacity for the supply of certain of our current and
future products and limits on supply may constrain sales of certain
of our current products and product candidate development.
In addition, sales of our products are affected by the
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
healthcare cost containment as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and others'
regulations and reimbursement policies may affect the development,
usage and pricing of our products. In addition, we compete with
other companies with respect to some of our marketed products as
well as for the discovery and development of new products. We
believe that some of our newer products, product candidates or new
indications for existing products, may face competition when and as
they are approved and marketed. Our products may compete against
products that have lower prices, established reimbursement,
superior performance, are easier to administer, or that are
otherwise competitive with our products. In addition, while we
routinely obtain patents for our products and technology, the
protection offered by our patents and patent applications may be
challenged, invalidated or circumvented by our competitors and
there can be no guarantee of our ability to obtain or maintain
patent protection for our products or product candidates. We cannot
guarantee that we will be able to produce commercially successful
products or maintain the commercial success of our existing
products. Our stock price may be affected by actual or perceived
market opportunity, competitive position, and success or failure of
our products or product candidates. Further, the discovery of
significant problems with a product similar to one of our products
that implicate an entire class of products could have a material
adverse effect on sales of the affected products and on our
business and results of operations. Our efforts to integrate the
operations of companies we have acquired may not be successful. We
may experience difficulties, delays or unexpected costs and not
achieve anticipated benefits and savings from our recently
announced restructuring plan. 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, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Cuyler Mayer, 805-447-6332
(media)
Arvind Sood, 805-447-1060
(investors)
References
- Amgen Data on File, Investigator Brochure.
- Teramoto T, Sasaki J, Ishibashi S, et al. Executive Summary of
the Japan Atherosclerosis Society (JAS) Guidelines for the
Diagnosis and Prevention of Atherosclerotic Cardiovascular Diseases
in Japan – 2012 version. J Atheroscler
Thromb. 2013;20(6):517-523.
- Teramoto T, Kashiwagi A, Ishibashi S, Daida H. Cross-Sectional
Survey to Assess the Status of Lipid Management in High-Risk
Patients With Dyslipidemia: Clinical Impact of Combination Therapy
With Ezetimibe. Current Therapeutic Research.
2013;73(1-2).
- National Human Genome Research Institute. Learning About
Familial Hypercholesterolemia. http://www.genome.gov/25520184.
Accessed August 2014.
- World Health Organization. Quantifying Selected Major Risks to
Health. In: The World Health Report 2002 - Reducing Risks,
Promoting Healthy Life. Chapter 4: Geneva: World.
- Merck Manuals website.
http://www.merckmanuals.com/professional/endocrine_and_metabolic_disorders/lipid_disorders/dyslipidemia.html.
Accessed February 2015.
- National Institute of Health (2009). Federal Register
Volume 74 (250). Washington, DC: U.S. Government Printing
Office. http://www.gpo.gov/fdsys/pkg/FR-2009-12-31/html/E9-31072.htm.
Accessed February 2015.
- Nordestgaard BG, Chapman MJ, Humphries SE, et al. Familial
Hypercholesterolaemia is Underdiagnosed and Undertreated in the
General Population: Guidance for Clinicians to Prevent Coronary
Heart Disease. Eur Heart J.
2013;34:3478-3490.
- Austin MA, Hutter CM, Zimmern RL., et al. Genetic Causes of
Monogenic Heterozygous Familial Hypercholesterolemia: a HuGE
Prevalence Review. Am J Epidemiol. 2004;160(5):407-420.
- Hopkins PN, Toth PP, Ballantyne CM, et al. Familial
Hypercholesterolemias: Prevalence, Genetics, Diagnosis and
Screening Recommendations From the National Lipid Association
Expert Panel on Familial Hypercholesterolemia. J Clin Lipid.
2011:5(3S):S9-S17.
- Daniels SR, Samuel SG, de Ferranti SD. Pediatric Aspects of
Familial Hypercholesterolemias: Recommendations from the National
Lipid Association Expert Panel on Familial Hypercholesterolemia.
J Clin Lipid. 2011:5(3S):S30-S37.
- Sjouke B, Kusters DM, Kindt I, et al. Homozygous autosomal
dominant hypercholesterolaemia in the
Netherlands: prevalence, genotype – phenotype relationship,
and clinical outcome. Eur Heart J. 2014; Epub ahead of
print. doi:10.1093/eurheartj/ehu058. Feb.
28, 2014.
- Raal FJ and Santos RD. Homozygous familial
hypercholesterolemia: Current perspectives on diagnosis and
treatment. Atherosclerosis. 2012;223(2):262-268.
- Abifadel M et al. Mutations in PCSK9 cause autosomal dominant
hypercholesterolemia. Nat
Genet. 2003;34:154-156.
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