THOUSAND OAKS, Calif.,
May 22, 2015 /PRNewswire/ -- Amgen
(NASDAQ: AMGN) today announced that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has adopted a positive opinion for the marketing
authorization of Repatha™ (evolocumab) recommending
approval for use in certain patients with high cholesterol. 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
The CHMP recommended granting Repatha marketing authorization
for:
- The treatment of adults with primary hypercholesterolemia
(heterozygous familial and non-familial [HeFH]) or mixed
dyslipidemia, as an adjunct to diet:
- in combination with a statin or statin with other
lipid-lowering therapies in patients unable to reach LDL-C goals
with the maximum tolerated dose of a statin, or
- alone or in combination with other lipid-lowering therapies in
patients who are statin-intolerant, or for whom a statin is
contraindicated.
- The treatment of adults and adolescents aged 12 years and over
with homozygous familial hypercholesterolemia (HoFH) in combination
with other lipid-lowering therapies.
The effect of Repatha on cardiovascular morbidity and mortality
has not yet been determined.
"We are pleased to receive a positive opinion from the CHMP for
Repatha as it is an important step in providing a new treatment
option for patients with high cholesterol, who are unable to reach
their LDL cholesterol goals with current therapies in the European
Union," said Sean E. Harper, M.D.,
executive vice president of Research and Development at Amgen.
"Uncontrolled high cholesterol is a burden on the health system and
we look forward to continuing to work with regulatory authorities
to bring Repatha to patients across Europe."
The Icelandic and Norwegian CHMP members have also agreed with
the above-mentioned recommendation on granting of the marketing
authorization.
The CHMP positive opinion will now be reviewed by
the European Commission (EC), which has the authority to
approve medicines for the European Union (EU). If approved, a
centralized marketing authorization with unified labeling will be
granted in the 28 countries that are members of the EU.
Norway, Iceland and Liechtenstein, as members of the European
Economic Area (EEA), will take corresponding decisions on the basis
of the decision of the EC.
The CHMP opinion is based on data from approximately 6,800
patients, including more than 4,500 patients with high cholesterol
in 10 Phase 3 trials. The Phase 3 studies evaluated the safety and
efficacy of Repatha in patients with elevated cholesterol,
including patients on statins with or without other lipid-lowering
therapies; patients who cannot tolerate statins; patients with
HeFH; and patients with HoFH, a rare and serious genetic
disorder.2
In Europe, up to 54 percent of
the population aged 25 and older has a total cholesterol ≥5.0
mmol/L (≥190 mg/dL).3 High cholesterol, particularly
elevated LDL-C, is the most common form of dyslipidemia, which is
an abnormality of cholesterol and/or fats in the
blood.4,5 Elevated LDL-C is recognized as a major risk
factor for cardiovascular disease.6,7
About Repatha™
(evolocumab)
Repatha™ (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.8 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 U.S. Food and Drug Administration (FDA) and EMA have
provisionally approved the use of the trade name Repatha.
About PROFICIO: Repatha™ (evolocumab) Clinical
Trial Program
PROFICIO, which stands for the Program to
Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of
PCSK9 In Different POpulations, is a large and comprehensive
clinical trial program evaluating Repatha™
(evolocumab) in 22 clinical trials, with a combined planned
enrollment of approximately 35,000 patients.
The Phase 3 program includes 16 trials to evaluate Repatha
administered every two weeks and monthly in multiple patient
populations, including in combination with statins in patients with
hyperlipidemia (LAPLACE-2 and YUKAWA-2); in patients with
hyperlipidemia who cannot tolerate statins (GAUSS-2 and GAUSS-3);
as a stand-alone treatment in patients with hyperlipidemia
(MENDEL-2); in patients whose elevated cholesterol is caused by
genetic disorders called heterozygous (RUTHERFORD-2 and TAUSSIG)
and homozygous (TESLA and TAUSSIG) familial hypercholesterolemia;
the effects of Repatha on lipoprotein metabolism (FLOREY); and the
administration of Repatha in statin-treated hyperlipidemic patients
(THOMAS-1 and THOMAS-2).
Five ongoing studies in the Repatha Phase 3 program will provide
long-term safety and efficacy data. These include FOURIER (Further
Cardiovascular OUtcomes Research with
PCSK9 Inhibition in Subjects with Elevated Risk),
which will assess whether treatment with Repatha in combination
with statin therapy compared to placebo plus statin therapy
reduces recurrent cardiovascular events in approximately 27,500
patients with cardiovascular disease; EBBINGHAUS (Evaluating PCSK9
Binding AntiBody Influence oN CoGnitive HeAlth in High
CardiovascUlar Risk Subjects), which will evaluate the effect of
Repatha on cognitive function in a subset of patients enrolled in
FOURIER; OSLER-2 (Open Label Study of Long TERm Evaluation Against
LDL-C Trial-2) in patients with high cholesterol who completed any
of the Phase 3 studies; GLAGOV (GLobal Assessment of Plaque
ReGression with a PCSK9 AntibOdy as Measured by IntraVascular
Ultrasound), which will determine the effect of Repatha on coronary
atherosclerosis in approximately 950 patients undergoing cardiac
catheterization; and TAUSSIG (Trial Assessing Long Term USe of
PCSK9 Inhibition in Subjects with Genetic LDL Disorders), which
will assess the long-term safety and efficacy of Repatha on LDL-C
in patients with severe familial hypercholesterolemia including
patients with homozygous familial hypercholesterolemia. The
DESCARTES (Durable Effect of PCSK9 Antibody CompARed wiTh
PlacEbo Study) study, a long-term safety and efficacy trial in
patients with hyperlipidemia at risk for cardiovascular disease,
has completed.
About Amgen Cardiovascular
Building on more than three
decades of experience in developing biotechnology medicines for
patients with serious illnesses, Amgen is dedicated to addressing
important scientific questions to advance care and improve the
lives of patients with cardiovascular disease, the leading cause of
morbidity and mortality worldwide.9 Amgen's research
into cardiovascular disease, and potential treatment options, is
part of a growing competency at Amgen that utilizes human genetics
to identify and validate certain drug targets. Through its own
research and development efforts, as well as partnerships, Amgen is
building a robust cardiovascular 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
May 22, 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
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claims. We depend on third parties for a significant portion of our
manufacturing capacity for the supply of certain of our current and
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of our current products and product candidate development.
In addition, sales of our products are affected by the
reimbursement policies imposed by third-party payors, 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
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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), the European Medicines Agency (EMA) or other
similar regulatory bodies, and no conclusions can or should be
drawn regarding the safety or effectiveness of the product
candidates.
CONTACT: Amgen, Thousand
Oaks
Trish Hawkins, 805-447-5631
(media)
Kristen Davis, 805-447-3008
(media)
Arvind Sood, 805-447-1060
(investors)
Amgen, European Union
Emma Gilbert, +41 41 369 2542
References
- Amgen Data on File, Investigator Brochure.
- National Human Genome Research Institute. Learning About
Familial Hypercholesterolemia. http://www.genome.gov/25520184.
Accessed May 2015.
- World Health Organization: Global Health Observatory (GHO)
data; Raised Cholesterol situations and trends; WHO 2015.
http://www.who.int/gho/ncd/risk_factors/cholesterol_text/en/
- 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 May 2015.
- American Heart Association (2012). Why Cholesterol Matters.
http://www.heart.org/HEARTORG/Conditions/Cholesterol/WhyCholesterolMatters/Why-Cholesterol-Matters_UCM_001212_Article.jsp.
Accessed May 2015.
- World Health Organization. Global Status Report on
Noncommunicable Diseases 2010. Geneva, 2011.
- Qian Y-W, Schmidt RJ, Zhang Y et al. Secreted PCSK9
downregulates low density lipoprotein receptor through
receptor-mediated endocytosis. J. Lipid Res. 2007. 48:
1488–1498.
- World Health Organization. Cardiovascular diseases (CVDs) fact
sheet. http://www.who.int/mediacentre/factsheets/fs317/en/.
Accessed May 2015.
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