THOUSAND OAKS, Calif. and
NAARDEN, Netherlands, Sept. 16, 2015 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and Dezima Pharma B.V. (Dezima) today announced that
the companies have entered into a definitive acquisition agreement
under which Amgen will acquire Dezima, a privately-held,
Netherlands-based biotechnology
company focused on developing innovative treatments for
dyslipidemia. Dezima shareholders have approved the agreement.
"With the recent launches of Repatha™ (evolocumab) and
Corlanor® (ivabradine), and today's acquisition of
Dezima, Amgen is proud to be on the leading edge of an exciting new
wave of treatments for cardiovascular disease, an illness impacting
millions of people worldwide," said Robert
A. Bradway, chairman and chief executive officer at
Amgen.
Dezima's lead molecule is TA-8995, an oral, once-daily
cholesteryl ester transfer protein (CETP) inhibitor. In a Phase 2b
clinical trial for dyslipidemia, TA-8995 reduced low-density
lipoprotein cholesterol (LDL-C) by 45 to 48 percent compared to
baseline. LDL-C reduction was consistent when TA-8995 was
administered as monotherapy or in combination with statins. The
most common adverse events were nasopharyngitis and headache.
"TA-8995 has demonstrated dramatic LDL-C lowering," said
Sean E. Harper, M.D., executive vice
president of Research and Development at Amgen. "With a portfolio
of TA-8995 and Repatha, our recently launched LDL-C lowering PCSK9
inhibitor, we will be able to offer more treatment options with
different mechanisms of action and modes of administration across
varying LDL-C levels and risk profiles."
Under the terms of the agreement, Amgen will pay $300 million in cash at closing and up to
$1.25 billion in additional payments
if certain development and sales milestones are achieved. Low
single-digit royalties will be paid on net product sales above a
certain threshold. The agreement is subject to customary closing
conditions, including regulatory approvals, and is expected to
close in the fourth quarter of this year. Following the completion
of the transaction, Dezima Pharma, which originally licensed rights
to TA-8995 from Mitsubishi Tanabe Pharma Corporation (MTPC), will
become a wholly owned subsidiary of Amgen. MTPC will receive from
Dezima a portion of the upfront payment, future development and
sales milestone payments, and royalties on net product sales if a
certain threshold is reached. MTPC will also retain development and
commercialization rights to TA-8995 in certain territories in
Asia, including Japan.
"We are delighted to join Amgen as the company has shown
impressive leadership in the cardiovascular space by their rapid
and state-of-the-art development program for Repatha, their
injectable PCSK9 inhibitor," said Rob
de Ree, chief executive officer of Dezima. "Owning both
Repatha and TA-8995, each innovative and complementary therapies
with the potential to serve a broad range of patients with high
cholesterol, will further solidify Amgen's position in the future
treatment of dyslipidemia."
Covington & Burling and De Brauw Blackstone Westbroek served
as legal counsel to Amgen. NautaDutilh served as legal counsel and
Moelis & Company served as a financial advisor to Dezima.
Amgen's cardiovascular portfolio includes Repatha, Corlanor and
omecamtiv mecarbil.
Repatha was approved by the U.S. Food and Drug Administration
(FDA) in August. In the U.S. it is indicated as an adjunct to diet
and maximally tolerated statin therapy for the treatment of adults
with heterozygous familial hypercholesterolemia (HeFH) or clinical
atherosclerotic cardiovascular disease (ASCVD), who require
additional lowering of LDL-C; and as an adjunct to diet and other
LDL-lowering therapies for the treatment of patients with
homozygous familial hypercholesterolemia (HoFH), who require
additional lowering of LDL-C.
In July, the European Commission (EC) granted marketing
authorization for Repatha for the treatment of adults with primary
hypercholesterolemia 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
from whom a statin is contraindicated; and as a treatment of adults
and adolescents aged 12 years and over with homozygous familial
hypercholesterolemia in combination with other lipid-lowering
therapies.
The effect of Repatha on cardiovascular morbidity and mortality
has not been determined.
Corlanor was approved by the FDA in April to reduce the risk of
hospitalization for worsening heart failure in patients with
stable, symptomatic chronic heart failure with left ventricular
ejection fraction (LVEF) < 35 percent, who are in sinus rhythm
with resting heart rate > 70 beats per minute (bpm) and either
are on maximally tolerated doses of beta blockers or have a
contraindication to beta blocker use.
Omecamtiv mecarbil is a small molecule activator of cardiac
myosin in Phase 2, which is being investigated for the treatment of
heart failure in collaboration with Cytokinetics.
About Cholesteryl Ester Transfer Protein (CETP)
The
Cholesteryl Ester Transfer Protein (CETP) facilitates the transfer
of cholesterol from HDL to other lipoproteins including LDL, in
exchange for triglycerides. The CETP mediated transfer of
cholesterol into LDL particles results into maturation of those LDL
particles to more atherogenic LDL particles, which contribute to
macrophage foam cell, and eventually plaque formation. Large
Mendelian randomization, epidemiological, and preclinical studies
have provided evidence for the notion that CETP activity is
inversely related to cardiovascular mortality and reduced activity
of CETP by pharmaceutical means or by naturally occurring mutations
in the CETP gene results in increased HDL and decreased LDL levels.
This provides a rationale for inhibition of CETP activity as a
therapeutic intervention in dyslipidemic conditions characterized
by either low HDL or high LDL cholesterol.
About Dezima Pharma
Dezima Pharma was founded in 2012
by John Kastelein, professor of
medicine at the Department of Vascular Medicine at the Academic
Medical Center of the University of Amsterdam, The Netherlands, and financed by
Forbion Capital Partners, BioGeneration Ventures and New Science
Ventures, and a EUR 5m loan
(Innovation Credit) from the Dutch government through RVO, an
agency of the Dutch Ministry of Economic Affairs, to develop novel
products to treat dyslipidemic patients suffering from
cardiovascular disease. TA-8995 is a CETP inhibitor. The company
has a Scientific Advisory Board including world-leading experts in
the dyslipidemia space such as Dr. Philip
Barter, professor at The Heart Research Institute,
Sydney, Australia, and Dr.
Bryan Brewer, senior research
consultant of Lipoprotein and Atherosclerosis Research at the
Medstar Research Institute, Washington,
D.C.
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.1 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.
Important Safety Information About Repatha
Repatha™ is
contraindicated in patients with a history of a serious
hypersensitivity reaction to Repatha. 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.
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, included:
Local injection site reactions that 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 4.6% 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 1609
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%).
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%).
Repatha is a human monoclonal antibody. As with all therapeutic
proteins, there is a potential for immunogenicity with Repatha.
Important Safety Information About Corlanor
- Contraindications: Corlanor® is
contraindicated in patients with acute decompensated heart failure,
blood pressure < 90/50 mmHg, sick sinus syndrome, sinoatrial
block, 3rd degree AV block (unless a functioning demand
pacemaker is present), a resting heart rate < 60 bpm prior to
treatment, severe hepatic impairment, pacemaker dependence (heart
rate imposed exclusively by the pacemaker) and concomitant use of
strong cytochrome P450 3A4 (CYP3A4) inhibitors.
- Fetal Toxicity: Corlanor® may cause fetal
toxicity when administered to a pregnant woman.
- Atrial Fibrillation: Corlanor® increases the
risk of atrial fibrillation. The rate of atrial fibrillation in
patients treated with Corlanor® compared to placebo was
5% vs. 3.9% per patient-year, respectively.
- Bradycardia and Conduction Disturbances: Bradycardia,
sinus arrest and heart block have occurred with
Corlanor®. Concurrent use of verapamil or diltiazem also
increases Corlanor® exposure and should be avoided.
Avoid use of Corlanor® in patients with 2nd
degree atrioventricular block unless a functioning demand pacemaker
is present.
- Adverse Reactions: The most common adverse drug
reactions in the SHIFT study occurring in > 1% higher on
Corlanor® than placebo were bradycardia (10% vs. 2.2%),
hypertension or increased blood pressure (8.9% vs. 7.8%), atrial
fibrillation (8.3% vs. 6.6%), and luminous phenomena (phosphenes)
or visual brightness (2.8% vs. 0.5%).
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 the current
expectations and beliefs of Amgen Inc. and its
subsidiaries (Amgen) 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 Inc.,
including Amgen Inc.'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 Inc.'s most recent Forms 10-K, 10-Q
and 8-K for additional information on the uncertainties and risk
factors related to Amgen's business. Unless otherwise
noted, Amgen is providing this information as
of Sept. 16, 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 Amgen projects.
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 Amgen and its partners
to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied
and Amgen expects similar variability in the
future. Amgen develops 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 Amgen may have believed at the
time of entering into such relationship. Also, Amgen or
others could identify safety, side effects or manufacturing
problems with Amgen's products after they are on the
market. Amgen's business may be impacted by government
investigations, litigation and product liability claims.
If Amgen fails to meet the compliance obligations in the
corporate integrity agreement between Amgen and the U.S.
government, Amgen could become subject to significant
sanctions. Amgen depends on third parties for a
significant portion of its manufacturing capacity for the supply of
certain of its current and future products and limits on supply may
constrain sales of certain of its current products and product
candidate development.
In addition, sales of Amgen's 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 Amgen's products. In
addition, Amgen competes with other companies with
respect to some of its marketed products as well as for the
discovery and development of new products. Amgen believes that
some of its newer products, product candidates or new indications
for existing products, may face competition when and as they are
approved and marketed. Amgen's products may compete
against products that have lower prices, established reimbursement,
superior performance, are easier to administer, or that are
otherwise competitive with its products. In addition,
while Amgen and its partners routinely obtain patents for
their products and technology, the protection
of Amgen's products offered by patents and patent
applications may be challenged, invalidated or circumvented by its
competitors and there can be no guarantee of Amgen's or
its partners' ability to obtain or maintain patent protection
for Amgen's products or product
candidates. Amgen cannot guarantee that it will be able
to produce commercially successful products or maintain the
commercial success of its existing
products. Amgen's stock price may be affected by actual
or perceived market opportunity, competitive position and success
or failure of its products or product candidates. Further, the
discovery of significant problems with a product similar to one
of Amgen's products that implicate an entire class of
products could have a material adverse effect on sales of the
affected products and on Amgen's business and results of
operations. Amgen's efforts to integrate the operations
of companies it has acquired may not be
successful. Amgen may experience difficulties, delays or
unexpected costs and not achieve anticipated cost savings from its
ongoing restructuring plan. Amgen's business performance
could affect or limit the ability of Amgen's Board of
Directors to declare a dividend or their ability to pay a dividend
or repurchase Amgen common stock.
The scientific information discussed in this news release
related to Amgen's 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)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
CONTACT: Instinctif Partners (on behalf of Dezima), Naarden
Melanie Toyne Sewell / Daniel Gooch
+44 (0) 20 7457 2020
References
- World Health Organization. Cardiovascular diseases (CVDs) fact
sheet
http://www.who.int/mediacentre/factsheets/fs317/en/. Accessed
August 2015.
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