THOUSAND OAKS, Calif.,
Aug. 25, 2015 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced that it will present six abstracts at
the upcoming ESC Congress 2015, organized by the European Society
of Cardiology, being held Aug. 29 –
Sept. 2 in London. Data will be presented evaluating
RepathaTM (evolocumab), a proprotein convertase
subtilisin/kexin type 9 (PCSK9) inhibitor approved in the European
Union (EU) for the treatment of patients with uncontrolled
cholesterol who require additional intensive low-density
lipoprotein cholesterol (LDL-C) reduction.1
"This has been a historic year for Amgen's cardiovascular
franchise with multiple regulatory milestones, including the recent
EU approval of Repatha, the first PCSK9 inhibitor approved by a
regulatory agency in the world, and we're excited to continue the
momentum with new data being presented at this year's ESC
Congress," said Sean E. Harper,
M.D., executive vice president of Research and Development at
Amgen. "We are committed to continuing to evaluate Repatha and look
forward to sharing long-term safety and efficacy data in patients
who are unable to tolerate effective doses of statins, as well as
findings on consistent LDL-C reductions in different patient
subgroups."
In addition to clinical results, data from Amgen's Center for
Observational Research will also be presented, including a Rapid
Fire Abstract presentation on statin usage and outcomes among
Medicare beneficiaries, a presentation on the identification and
characterization of patients with heterozygous familial
hypercholesterolemia (HeFH), and a discussion examining the burden
of cardiovascular hospitalizations in patients who have had a
myocardial infarction. In addition, Global Health Economic (GHE)
data on the identification and management of patients who cannot
tolerate statins will be presented.
Amgen-sponsored abstracts and satellite symposium at ESC
Congress 2015 include:
Repatha
- Clinical equivalence of evolocumab among patient subgroups
in PROFICIO: a pooled analysis of 3146 patients from phase 3
studies
Abstract P1756, Poster Presentation, Sunday, Aug. 30, 8:30
a.m.-12:30 p.m. BST (Poster Area)
- Long-term safety and efficacy of evolocumab in patients with
statin intolerance
Abstract P5968, Moderated Poster
Presentation, Tuesday, Sept. 1,
3:47-3:55 p.m. BST (Moderated Poster
Station – Poster Area)
- Satellite Symposium – PCSK9 inhibition: an important step
forward in treating dyslipidemia in high-risk
patients
Tuesday, Sept. 1,
12:45-1:45 p.m. BST (Ankara – Village 7)
Observational Research
- Burden of cardiovascular hospitalizations following
myocardial infarction among older adults
Abstract P3667,
Poster Presentation, Monday, Aug. 31,
8:30 a.m.-12:30 p.m. BST (Poster
Area)
- Identification and characterization of heterozygous familial
hypercholesterolemia patients using the Vanderbilt University Medical Center Synthetic
Derivative database
Abstract P5374, Poster Presentation,
Tuesday, Sept. 1, 8:30 a.m.-12:30 p.m. BST (Poster Area)
- Patterns of statin use and outcomes following myocardial
infarction among Medicare beneficiaries
Abstract P6653,
Rapid Fire Abstract Presentation, Wednesday,
Sept. 2, 9:33-9:42 a.m. BST
(Victoria Park – The Hub)
Health Economics
- Identification and management of statin-intolerance: a
survey of clinicians from 13 countries
Abstract P1677,
Poster Presentation, Sunday, Aug. 30,
8:30 a.m.-12:30 p.m. BST (Poster
Area)
About RepathaTM
(evolocumab)
RepathaTM (evolocumab) is a 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.2 Repatha, 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
In the EU, the European Commission (EC) approved Repatha
for:
- The treatment of adults with primary hypercholesterolemia
(heterozygous familial [HeFH] and non-familial) 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 FH in combination with other lipid-lowering
therapies.
The effect of Repatha on cardiovascular morbidity and mortality
has not yet been determined.
Important EU Safety Information
▼This medicinal product is subject to additional monitoring.
This will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
reactions.
Dosage and Administration: Repatha is for subcutaneous
injection into the abdomen, thigh or upper arm region. Prior to
initiating Repatha, secondary causes of hyperlipidaemia or mixed
dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be
excluded. Primary hypercholesterolaemia and mixed dyslipidaemia in
adults: The recommended dose of Repatha is either 140 mg every two
weeks or 420 mg once monthly; both doses are clinically equivalent.
The safety and efficacy of Repatha in children aged less than 18
years has not been established. Homozygous familial
hypercholesterolaemia in adults and adolescents aged 12 years and
over: The initial recommended dose is 420 mg once monthly. After 12
weeks of treatment, dose frequency can be up titrated to 420 mg
once every 2 weeks if a clinically meaningful response is not
achieved. Patients on apheresis may initiate treatment with 420 mg
every two weeks to correspond with their apheresis schedule. The
safety and efficacy of Repatha in children aged less than 12 years
has not been established.
Contraindications: Hypersensitivity to the active
substance or to any of the excipients.
Special Warnings and Precautions: Renal impairment:
Patients with severe renal impairment (defined as eGFR < 30
mL/min/1.73 m2) have not been studied. Repatha
should be used with caution in patients with severe renal
impairment. Hepatic impairment: In patients with moderate hepatic
impairment, a reduction in total evolocumab exposure was observed
that may lead to a reduced effect on LDL‑C reduction. Therefore,
close monitoring may be warranted in these patients. Patients with
severe hepatic impairment (Child-Pugh C) have not been studied.
Repatha should be used with caution in patients with severe hepatic
impairment. Dry natural rubber: The needle cover of the glass
pre-filled syringe and of the pre-filled pen is made from dry
natural rubber (a derivative of latex), which may cause allergic
reactions. Sodium content: Repatha contains less than 1 mmol sodium
(23 mg) per dose, i.e. it is essentially 'sodium-free'.
Interactions: No formal drug-drug interaction studies
have been conducted for Repatha. No studies on pharmacokinetic and
pharmacodynamics interaction between Repatha and lipid-lowering
drugs other than statins and ezetimibe have been conducted.
Fertility, Pregnancy and Lactation: There are no or
limited amount of data from the use of Repatha in pregnant women.
Repatha should not be used during pregnancy unless the clinical
condition of the woman requires treatment with evolocumab. It is
unknown whether evolocumab is excreted in human milk. A risk to
breastfed newborns/infants cannot be excluded. No data on the
effect of evolocumab on human fertility are
available.
Undesirable Effects: The following common (> 1/100 to
< 1/10) adverse reactions have been reported in pivotal,
controlled clinical studies: influenza, nasopharyngitis, upper
respiratory tract infection, rash, nausea, back pain, arthralgia,
injection site reactions. Please consult the SmPC for a full
description of undesirable effects.
Pharmaceutical Precautions: Store in a refrigerator (2
degrees C – 8 degrees C). Do not freeze. Keep the
pre-filled syringe or the pre-filled pen in the original carton in
order to protect from light. If removed from the refrigerator,
Repatha may be stored at room temperature (up to 25 degrees C) in
the original carton and must be used within 1 week.
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.3 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 cardiovascular portfolio consisting of several approved
and 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
Aug. 25, 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 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
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 ongoing
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 specific to the European
Union. 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 in the U.S.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis: 805-447-3008
(media)
Trish Hawkins: 805-447-5631
(media)
Arvind Sood: 805-447-1060
(investors)
References
- Amgen Data on File, Investigator Brochure.
- Lopez D. PCSK9: An enigmatic protease. Biochim Biophys
Acta. 2008;184-191.
- World Health Organization. Cardiovascular diseases (CVDs) fact
sheet. http://www.who.int/mediacentre/factsheets/fs317/en/.
Accessed August 2015.
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