TAVNEOS® (avacopan), a
First-in-Class Medicine for Patients With Severe Active
ANCA-Associated Vasculitis, Added to Inflammation Portfolio
THOUSAND
OAKS, Calif., Oct. 20,
2022 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today
announced that it has successfully completed its previously
announced acquisition of ChemoCentryx, Inc. (NASDAQ: CCXI), a
biopharmaceutical company focused on orally administered
therapeutics to treat autoimmune diseases, inflammatory disorders
and cancer, for $52 per share in
cash, representing aggregate merger consideration of approximately
$3.7 billion.
"ChemoCentryx enhances Amgen's leading inflammation and
nephrology portfolio and includes TAVNEOS® (avacopan), a
first-in-class treatment for severe active anti-neutrophil
cytoplasmic autoantibody-associated vasculitis (ANCA-associated
vasculitis), an autoimmune disease for which there remains
significant unmet medical need," said Robert A. Bradway, chairman and chief executive
officer at Amgen. "We look forward to welcoming the dedicated
professionals from ChemoCentryx who share our passion for advancing
innovation that makes a difference for patients. Together, we aim
to serve more patients affected by serious diseases."
The acquisition includes TAVNEOS®, an orally
administered selective complement 5a receptor inhibitor that was
approved by the U.S. Food and Drug Administration (FDA) in
October 2021 as an adjunctive therapy
for adults with severe active ANCA-associated vasculitis in
addition to standard of care, which generally consists of
glucocorticoids and either rituximab or cyclophosphamide
immunosuppressant therapy. Beyond its approved ANCA-associated
vasculitis indication, TAVNEOS® is also being studied in
additional inflammatory diseases, including hidradenitis
suppurativa (HS), a severe and deforming chronic dermatological
condition, and complement 3 glomerulopathy (C3G), a rare genetic
kidney disease.
In addition to TAVNEOS®, the acquisition adds three
early-stage drug candidates that target chemoattractant receptors
and other inflammatory diseases and an oral checkpoint for
cancer.
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.
Amgen is one of the 30 companies that comprise the Dow Jones
Industrial Average and is also part of the Nasdaq-100 index.
In 2021, Amgen was named one of the 25 World's Best Workplaces™ by
Fortune and Great Place to Work™ and one of the 100 most
sustainable companies in the world by Barron's.
For more information, visit www.amgen.com and follow
us on www.twitter.com/amgen.
About ChemoCentryx
ChemoCentryx is a
biopharmaceutical company commercializing and developing new
medications for inflammatory and autoimmune diseases and
cancer. ChemoCentryx targets the chemokine and
chemoattractant systems to discover, develop and commercialize
orally administered therapies. In the United
States, ChemoCentryx markets
TAVNEOS® (avacopan), the first approved orally
administered inhibitor of the complement 5a receptor as an
adjunctive treatment for adult patients with severe active
ANCA-associated vasculitis. TAVNEOS is also in late-stage clinical
development for the treatment of severe hidradenitis suppurativa
and C3 glomerulopathy (C3G).
Additionally, ChemoCentryx has early-stage drug
candidates that target chemoattractant receptors in other
inflammatory and autoimmune diseases and in cancer. For more
information
about ChemoCentryx visit www.chemocentryx.com.
About TAVNEOS® (avacopan)
TAVNEOS
(avacopan), approved by the FDA as an adjunctive treatment of
ANCA-associated vasculitis, is a first-in-class, orally
administered small molecule that employs a novel, highly targeted
mode of action in complement-driven autoimmune and inflammatory
diseases. While the precise mechanism in ANCA vasculitis has not
been definitively established, TAVNEOS, by blocking the complement
5a receptor (C5aR) for the pro-inflammatory complement system
fragment known as C5a on destructive inflammatory cells such as
blood neutrophils, is presumed to arrest the ability of those cells
to do damage in response to C5a activation, which is known to be
the driver of ANCA vasculitis. TAVNEOS's selective inhibition of
only the C5aR leaves the beneficial C5a pathway through the C5L2
receptor functioning normally.
ChemoCentryx is also developing TAVNEOS for the treatment
of patients with C3 glomerulopathy (C3G), severe hidradenitis
suppurativa (HS) and lupus nephritis (LN). The U.S. Food and
Drug Administration granted TAVNEOS orphan drug designation
for ANCA-associated vasculitis and C3G. The European
Commission has granted orphan medicinal product designation
for TAVNEOS for the treatment of two forms of ANCA-associated
vasculitis: microscopic polyangiitis and granulomatosis with
polyangiitis (formerly known as Wegener's granulomatosis), as well
as for C3G.
About ANCA-Associated Vasculitis
ANCA-associated
vasculitis is an umbrella term for a group of multi-system
autoimmune diseases with small vessel inflammation. Inflamed
vessels may rupture or become occluded giving rise to a broad array
of clinical symptoms and signs related to a systemic inflammatory
response which may result in profound injury and dysfunction in the
kidneys, lungs and other organs. Prior to the approval of TAVNEOS,
treatment for ANCA-associated vasculitis was limited to courses of
non-specific immuno-suppressants (cyclophosphamide or rituximab),
combined with the administration of daily glucocorticoids
(steroids) for prolonged periods of time, which can be associated
with significant clinical risk including death from infection.
U.S. PRESCRIBING INFORMATION
TAVNEOS (avacopan)
is indicated as an adjunctive treatment of adult patients with
severe active anti-neutrophil cytoplasmic autoantibody
(ANCA)-associated vasculitis (granulomatosis with polyangiitis
[GPA] and microscopic polyangiitis [MPA]) in combination with
standard therapy including glucocorticoids. TAVNEOS does not
eliminate glucocorticoid use.
IMPORTANT SAFETY INFORMATION
Contraindications
Serious hypersensitivity to avacopan or to any of the
excipients
Warning and Precautions
Hepatotoxicity: Serious cases of hepatic injury have been
observed in patients taking TAVNEOS, including life-threatening
events. Obtain liver test panel before initiating TAVNEOS, every 4
weeks after start of therapy for six months and as clinically
indicated thereafter. Monitor patients closely for hepatic adverse
reactions, and consider pausing or discontinuing treatment as
clinically indicated (refer to section 5.1 of the Prescribing
Information). TAVNEOS is not recommended for patients with active,
untreated and/or uncontrolled chronic liver disease (e.g., chronic
active hepatitis B, untreated hepatitis C, uncontrolled autoimmune
hepatitis) and cirrhosis. Consider the risk and benefit before
administering this drug to a patient with liver disease.
Serious Hypersensitivity Reactions: Cases of angioedema occurred
in a clinical trial, including one serious event requiring
hospitalization. Discontinue immediately if angioedema occurs and
manage accordingly. TAVNEOS must not be re-administered unless
another cause has been established.
Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation,
including life threatening hepatitis B, was observed in the
clinical program. Screen patients for HBV. For patients with
evidence of prior infection, consult with physicians with expertise
in HBV and monitor during TAVNEOS therapy and for six months
following. If patients develop HBV reactivation, immediately
discontinue TAVNEOS and concomitant therapies associated with HBV
reactivation, and consult with experts before resuming.
Serious Infections: Serious infections, including fatal
infections, have been reported in patients receiving TAVNEOS. The
most common serious infections reported in TAVNEOS group were
pneumonia and urinary tract infections. Avoid use of TAVNEOS in
patients with active, serious infection, including localized
infections. Consider the risks and benefits before initiating
TAVNEOS in patients with chronic infection, at increased risk of
infection or who have been to places where certain infections are
common.
Adverse Reactions
The most common adverse reactions (≥5% of patients and higher in
the TAVNEOS group vs. prednisone group) were: nausea, headache,
hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal
pain, dizziness, blood creatinine increased, and paresthesia.
Drug Interactions
Avoid coadministration of TAVNEOS with strong and moderate
CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered
with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Monitor
for adverse reactions and consider dose reduction of certain
sensitive CYP3A4 substrates.
Please see Full Prescribing
Information and Medication Guide.
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 any statements on the
outcome, benefits and synergies of collaborations, or potential
collaborations, with any other company (including BeiGene, Ltd.,
Kyowa-Kirin Co., Ltd., or any collaboration to manufacture
therapeutic antibodies against COVID-19), the performance of
Otezla® (apremilast) (including anticipated Otezla sales
growth and the timing of non-GAAP EPS accretion), the Five Prime
Therapeutics, Inc. acquisition, the Teneobio, Inc. acquisition, or
the ChemoCentryx, Inc. acquisition (including the prospective
performance and outlook of ChemoCentryx's business, performance and
opportunities and any potential strategic benefits, synergies or
opportunities expected as a result of such acquisition), as well as
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, effects of pandemics or other widespread health problems
such as the ongoing COVID-19 pandemic on our business, 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 current reports on 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, including our devices, 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,
including in Puerto Rico, 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. An outbreak
of disease or similar public health threat, such as COVID-19, and
the public and governmental effort to mitigate against the spread
of such disease, could have a significant adverse effect on the
supply of materials for our manufacturing activities, the
distribution of our products, the commercialization of our product
candidates, and our clinical trial operations, and any such events
may have a material adverse effect on our product development,
product sales, business and results of operations. We rely on
collaborations with third parties for the development of some of
our product candidates and for the commercialization and sales of
some of our commercial products. 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 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, some raw materials, medical
devices and component parts for our products are supplied by sole
third-party suppliers. Certain of our distributors, customers and
payers have substantial purchasing leverage in their dealings with
us. 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 collaborate with or acquire other companies, products or
technology, and to integrate the operations of companies or to
support the products or technology we have acquired, may not be
successful. There can be no guarantee that we will be able to
realize any of the strategic benefits, synergies or opportunities
arising from the ChemoCentryx acquisition, and such benefits,
synergies or opportunities may take longer to realize than
expected. We may not be able to successfully integrate
ChemoCentryx, and such integration may take longer, be more
difficult or cost more than expected. A breakdown, cyberattack or
information security breach could compromise the confidentiality,
integrity and availability of our systems and our data. Our stock
price is volatile and may be affected by a number of events. Our
business and operations may be negatively affected by the failure,
or perceived failure, of achieving our environmental, social and
governance objectives. The effects of global climate change and
related natural disasters could negatively affect our business and
operations. Global economic conditions may magnify certain risks
that affect our business. 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. We
may not be able to access the capital and credit markets on terms
that are favorable to us, or at all.
CONTACT: Amgen, Thousand Oaks
Jessica Akopyan, 805-440-5721
(media)
Megan Fox, 805-447-1423 (media)
Arvind Sood, 805-447-1060
(investors)
View original content to download
multimedia:https://www.prnewswire.com/news-releases/amgen-successfully-completes-acquisition-of-chemocentryx-301654916.html
SOURCE Amgen
