THOUSAND OAKS, Calif.,
Jan. 5, 2017 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that the United States
District Court in Delaware granted
Amgen's request for a permanent injunction prohibiting Sanofi and
Regeneron from infringing two patents that Amgen holds for
Repatha® (evolocumab) by manufacturing, using, selling
or offering alirocumab for sale in the
United States. The injunction will not take effect
immediately as the court has delayed its imposition for 30 days to
allow defendants the opportunity to seek expedited review of this
decision. The judge's decision follows a jury verdict in
March 2016 in Amgen's favor in a
trial on the validity of two Amgen patents that describe and claim
monoclonal antibodies to proprotein convertase subtilisin/kexin
type 9 (PCSK9).
"We are pleased with today's decision that recognizes Amgen is
entitled to an injunction against further infringement of our
patent rights. Sanofi and Regeneron admitted that they had
infringed our patents, and the jury upheld our patents as valid.
Protecting intellectual property is essential to our industry as it
reinforces the incentives for the large and risky investments we
make in innovation to bring forward new medicines to treat
serious diseases," said Robert A.
Bradway, chairman and chief executive officer at Amgen.
Bradway continued, "Heart disease is the biggest health care
challenge for society today and Repatha aims to help address this
challenge by providing a profound reduction in
LDL-cholesterol."
Amgen has the ability to supply all potential Repatha patients
and will work to ensure a smooth transition for patients who wish
to switch to Repatha.
About Repatha® (evolocumab)
Repatha® (evolocumab) is a human monoclonal
antibody that inhibits proprotein convertase subtilisin/kexin type
9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9
from binding to the low-density lipoprotein (LDL) receptor (LDLR),
preventing PCSK9-mediated LDLR degradation and permitting LDLR to
recycle back to the liver cell surface. By inhibiting the binding
of PCSK9 to LDLR, Repatha increases the number of LDLRs available
to clear LDL from the blood, thereby lowering LDL-C
levels.1
The FOURIER outcomes trial is designed to evaluate whether
treatment with Repatha or placebo on top of optimized statin
therapy, reduces the risk of cardiovascular events in patients with
clinically evident atherosclerotic disease. The trial completed
patient enrollment in June 2015. The
primary endpoint for the FOURIER trial is major cardiovascular
events defined as the composite of cardiovascular death, myocardial
infarction (MI), stroke, hospitalization for unstable angina or
coronary revascularization. The key secondary endpoint is the
composite of cardiovascular death, MI or stroke. The trial is
planned to continue until at least 1,630 patients experience the
secondary endpoint, thereby providing 90 percent power to detect a
relative reduction of 15 percent in this endpoint. Top-line results
from the approximately 27,500-patient event-driven FOURIER study
are anticipated in the first quarter of 2017.
Repatha is approved in more than 40 countries, including the
U.S., Japan, Canada and in all 28 countries that are
members of the European Union. Applications in other countries are
pending.
Important U.S. Product Information
Repatha® is indicated as an adjunct to diet
and:
- Maximally tolerated statin therapy for treatment of adults with
heterozygous familial hypercholesterolemia (HeFH) or clinical
atherosclerotic cardiovascular disease (ASCVD), who require
additional lowering of low-density lipoprotein cholesterol
(LDL-C)
- Other LDL-lowering therapies (e.g., statins, ezetimibe, LDL
apheresis) in patients with homozygous familial
hypercholesterolemia (HoFH) who require additional lowering of
LDL-C
The effect of Repatha® on cardiovascular
morbidity and mortality has not been determined.
The safety and effectiveness of Repatha® have
not been established in pediatric patients with HoFH who are
younger than 13 years old.
The safety and effectiveness of Repatha® have
not been established in pediatric patients with primary
hyperlipidemia or HeFH.
Important U.S. Safety Information
Contraindication: Repatha® is contraindicated
in patients with a history of a serious hypersensitivity reaction
to Repatha®.
Allergic reactions: Hypersensitivity reactions (e.g.
rash, urticaria) have been reported in patients treated with
Repatha®, including some that led to discontinuation of
therapy. If signs or symptoms of serious allergic reactions occur,
discontinue treatment with Repatha®, treat according to
the standard of care, and monitor until signs and symptoms
resolve.
Adverse reactions: The most common adverse reactions
(>5% of Repatha® -treated patients and more
common than placebo) were: nasopharyngitis, upper respiratory tract
infection, influenza, back pain, and injection site reactions.
In a 52-week trial, adverse reactions led to discontinuation of
treatment in 2.2% of Repatha® -treated patients and
1% of placebo-treated patients. The most common adverse reaction
that led to Repatha® treatment discontinuation and
occurred at a rate greater than placebo was myalgia (0.3% versus 0%
for Repatha® and placebo, respectively).
Adverse reactions from a pool of the 52-week trial and seven
12-week trials:
Local injection site reactions occurred in 3.2% and 3.0% of
Repatha® -treated and placebo-treated patients,
respectively. The most common injection site reactions were
erythema, pain, and bruising. The proportions of patients who
discontinued treatment due to local injection site reactions in
Repatha® -treated patients and placebo-treated
patients were 0.1% and 0%, respectively.
Allergic reactions occurred in 5.1% and 4.7% of
Repatha® -treated and placebo-treated patients,
respectively. The most common allergic reactions were rash (1.0%
versus 0.5% for Repatha® and placebo,
respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus
0.2%), and urticaria (0.4% versus 0.1%).
Neurocognitive events were reported in less than or equal to
0.2% in Repatha®-treated and placebo-treated
patients.
In a pool of placebo- and active-controlled trials, as well as
open-label extension studies that followed them, a total of 1,988
patients treated with Repatha® had at least one
LDL-C value <25 mg/dL. Changes to background lipid-altering
therapy were not made in response to low LDL-C values, and
Repatha® dosing was not modified or interrupted on
this basis. Although adverse consequences of very low LDL-C were
not identified in these trials, the long-term effects of very low
levels of LDL-C induced by Repatha® are
unknown.
Musculoskeletal adverse reactions were reported in 14.3% of
Repatha® -treated patients and 12.8% of
placebo-treated patients. The most common adverse reactions that
occurred at a rate greater than placebo were back pain (3.2% versus
2.9% for Repatha® and placebo, respectively),
arthralgia (2.3% versus 2.2%), and myalgia (2.0% versus 1.8%).
Homozygous Familial Hypercholesterolemia (HoFH): In 49
patients with homozygous familial hypercholesterolemia studied in a
12-week, double-blind, randomized, placebo-controlled trial, 33
patients received 420 mg of Repatha® subcutaneously
once monthly. The adverse reactions that occurred in at least 2
(6.1%) Repatha®-treated patients and more frequently
than in placebo-treated patients, included upper respiratory tract
infection (9.1% versus 6.3%), influenza (9.1% versus 0%),
gastroenteritis (6.1% versus 0%), and nasopharyngitis (6.1% versus
0%).
Immunogenicity: Repatha® is a human
monoclonal antibody. As with all therapeutic proteins, there is a
potential for immunogenicity with Repatha®.
Please contact Amgen Medinfo at 800-77-AMGEN (800-772-6436) or
844-REPATHA (844-737-2842) regarding
Repatha® availability or find more information,
including full Prescribing Information, at www.amgen.com and
www.Repatha.com.
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.2
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
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 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 the current
expectations and beliefs of Amgen. 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 reports filed by Amgen, including our most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and Form 8-K. Unless otherwise noted, Amgen is providing
this information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future
events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project. Our results
may be affected by our ability to successfully market both new and
existing products domestically and internationally, clinical and
regulatory developments involving current and future products,
sales growth of recently launched products, competition from other
products including biosimilars, difficulties or delays in
manufacturing our products and global economic conditions. In
addition, sales of our products are affected by pricing pressure,
political and public scrutiny and 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.
Furthermore, our research, testing, pricing, marketing and other
operations are subject to extensive regulation by domestic and
foreign government regulatory authorities. 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 product liability
claims. In addition, our business may be impacted by the adoption
of new tax legislation or exposure to additional tax liabilities.
If we fail to meet the compliance obligations in the corporate
integrity agreement between us and the U.S. government, we could
become subject to significant sanctions. Further, 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, or we
may fail to prevail in present and future intellectual property
litigation. We perform a substantial amount of our commercial
manufacturing activities at a few key facilities and also depend on
third parties for a portion of our manufacturing activities, and
limits on supply may constrain sales of certain of our current
products and product candidate development. In addition, we compete
with other companies with respect to many of our marketed products
as well as for the discovery and development of new products.
Discovery or identification of new product candidates cannot be
guaranteed and movement from concept to product is uncertain;
consequently, there can be no guarantee that any particular product
candidate will be successful and become a commercial product.
Further, some raw materials, medical devices and component parts
for our products are supplied by sole third-party suppliers. 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 acquire
other companies or products and to integrate the operations of
companies we have acquired may not be successful. We may not be
able to access the capital and credit markets on terms that are
favorable to us, or at all. We are increasingly dependent on
information technology systems, infrastructure and data security.
Our stock price is volatile and may be affected by a number of
events. Our business performance could affect or limit the ability
of our Board of Directors to declare a dividend or our ability to
pay a dividend or repurchase our common stock.
CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
References
- Repatha® U.S. Prescribing
Information. Amgen.
- World Health Organization. Cardiovascular diseases (CVDs) fact
sheet. http://www.who.int/mediacentre/factsheets/fs317/en/.
Accessed August 2016.
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SOURCE Amgen