Acquisition Includes TAVNEOS®
(avacopan), a First-in-Class Medicine for Patients With Serious
Autoimmune Disease
Tavneos Adds to Amgen's Decades-Long
Leadership in Inflammation and Nephrology
THOUSAND
OAKS, Calif. and SAN CARLOS,
Calif., Aug. 4, 2022 /PRNewswire/ -- Amgen
(NASDAQ: AMGN) and ChemoCentryx, Inc., (NASDAQ: CCXI), a
biopharmaceutical company focused on orally administered
therapeutics to treat autoimmune diseases, inflammatory disorders
and cancer, today announced that the companies have entered into a
definitive agreement under which Amgen will acquire ChemoCentryx
for $52 per share in cash,
representing an enterprise value of approximately $3.7 billion.
"The acquisition of ChemoCentryx represents a compelling
opportunity for Amgen to add to our decades-long leadership in
inflammation and nephrology with TAVNEOS, a transformative,
first-in-class treatment for ANCA-associated vasculitis," said
Robert A. Bradway, chairman and
chief executive officer at Amgen. "We are excited to join in the
TAVNEOS launch and help many more patients with this serious and
sometimes life-threatening disease for which there remains
significant unmet medical need. We also look forward to welcoming
the highly skilled team from ChemoCentryx that shares our passion
for serving patients suffering from serious diseases."
"A fierce commitment to improving human lives is the bond that
unites Amgen and ChemoCentryx today," said Thomas J. Schall, Ph.D., president and chief
executive officer of ChemoCentryx. "Last year, after 25 years of
proud history, we at CCXI delivered on our founding promise with
the approval of TAVNEOS for patients with anti-neutrophil
cytoplasmic autoantibody-associated vasculitis (ANCA-associated
vasculitis). It is an honor to now join Amgen's great mission, and
together begin a bright new era bringing landscape-shaping
medicines like TAVNEOS to those who will benefit most."
TAVNEOS is an orally administered selective complement component
5a receptor inhibitor. It was approved by the U.S. Food and Drug
Administration in October 2021 as an
adjunctive treatment for adult patients with severe active
ANCA-associated vasculitis, specifically granulomatosis with
polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main
forms of ANCA-associated vasculitis), in combination with standard
therapy.
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.
Amgen is a leader in inflammation and nephrology. The company's
inflammation portfolio includes Otezla®,
ENBREL®, TEZSPIRE®, AMGEVITA™ (a biosimilar
to HUMIRA®), RIABNI™ (a biosimilar to
Rituxan®), and AVSOLA® (a biosimilar to
REMICADE®). Amgen's pipeline includes four innovative
Phase 2 inflammation medicines – efavaleukin alpha for systemic
lupus erythematosus and ulcerative colitis, ordesekimab for celiac
disease, rocatinlimab for atopic dermatitis and rozibafusap alfa
for systemic lupus erythematosus – as well as ABP 654, a biosimilar
to STELARA® that is in Phase 3 development. Amgen's
nephrology portfolio includes EPOGEN®,
Aranesp®, Parsabiv® and
Sensipar®.
U.S. sales of TAVNEOS in the first quarter of 2022, the first
full quarter of sales, were $5.4
million. TAVNEOS is also approved in major markets outside
the U.S., including the European Union and Japan. Vifor Fresenius Medical Care Renal
Pharma Ltd. will retain exclusive rights to commercialize TAVNEOS
outside the U.S., except in Japan
where Kissei Pharmaceutical Co., Ltd. holds commercialization
rights and Canada where Otsuka
Canada Pharmaceutical holds commercialization rights.
In addition to TAVNEOS, ChemoCentryx has three early-stage drug
candidates that target chemoattractant receptors in other
inflammatory diseases and an oral checkpoint inhibitor for
cancer.
The transaction has been unanimously approved by each company's
board of directors. The transaction is subject to ChemoCentryx
stockholder approval, regulatory approvals and other customary
closing conditions, and is expected to close in the fourth quarter
of 2022.
Amgen management will comment further on the ChemoCentryx
transaction on its Q2 earnings call today.
PJT Partners acted as financial advisor to Amgen and Wachtell,
Lipton, Rosen & Katz is serving as its legal advisor. Goldman
Sachs & Co. LLC acted as financial advisor to ChemoCentryx, and
Latham & Watkins LLP is serving as its legal advisor.
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.
Additional Information
This report may be deemed solicitation material in respect of
the proposed acquisition of ChemoCentryx by Amgen. ChemoCentryx
expects to file with the SEC a proxy statement and other relevant
documents with respect to a special meeting of the stockholders of
ChemoCentryx to approve the proposed merger. Investors of
ChemoCentryx are urged to read the definitive proxy statement and
other relevant materials carefully and in their entirety when they
become available because they will contain important information
about ChemoCentryx, Amgen and the proposed Merger. Investors may
obtain a free copy of these materials (when they are available) and
other documents filed by ChemoCentryx with the SEC at the SEC's
website at www.sec.gov, at ChemoCentryx's website at
https://chemocentryx.com or by sending a written request to
ChemoCentryx at 835 Industrial Road, Suite 600, San Carlos, CA 94070, Attention: Legal.
Participants in the Solicitation
ChemoCentryx and its directors, executive officers and certain
other members of management and employees may be deemed to be
participants in soliciting proxies from its stockholders in
connection with the proposed merger. Information regarding the
persons who may, under the rules of the SEC, be considered to be
participants in the solicitation of ChemoCentryx's stockholders in
connection with the proposed merger will be set forth in
ChemoCentryx's definitive proxy statement for its special
stockholders meeting. Additional information regarding these
individuals and any direct or indirect interests they may have in
the proposed Merger will be set forth in the definitive proxy
statement when and if it is filed with the SEC in connection with
the proposed merger.
Forward-Looking Statements
This communication contains forward-looking statements. These
forward-looking statements generally include statements that are
predictive in nature and depend on or refer to future events or
conditions, and include words such as "expect," "anticipate,"
"outlook," "could," "target," "project," "intend," "plan,"
"believe," "seek," "estimate," "should," "may," "assume" and
"continue" as well as variations of such words and similar
expressions. By their nature, forward-looking statements involve
risks and uncertainty because they relate to events and depend on
circumstances that will occur in the future, and there are many
factors that could cause actual results and developments to differ
materially from those expressed or implied by these forward-looking
statements. Forward-looking statements include, among other things,
statements about the potential benefits of the proposed acquisition
of ChemoCentryx by Amgen (the "proposed transaction"); the
prospective performance and outlook of ChemoCentryx's business,
performance and opportunities; any potential strategic benefits,
synergies or opportunities expected as a result of the proposed
transaction; the ability of the parties to complete the proposed
transaction and the expected timing of completion of the proposed
transaction; as well as any assumptions underlying any of the
foregoing.
These statements are not guarantees of future performance and
they involve certain risks, uncertainties and assumptions that are
difficult to predict. We caution you that actual outcomes and
results may differ materially from what is expressed, implied or
forecasted by our forward-looking statements. There can be no
guarantee that the proposed transaction will be completed, or that
it will be completed as currently proposed, or at any particular
time. Neither can there be any guarantee that Amgen or ChemoCentryx
will achieve any particular future financial results, or that Amgen
will be able to realize any of the potential strategic benefits,
synergies or opportunities as a result of the proposed acquisition.
In particular, our expectations could be affected by, among other
things: the risk that the proposed transaction may not be completed
in a timely manner or at all; the possibility that competing offers
or acquisition proposals for ChemoCentryx will be made; the
possibility that required regulatory, stockholder or other
approvals or other conditions to the consummation of proposed
transaction may not be satisfied on a timely basis or at all (and
the risk that such approvals may result in the imposition of
conditions that could adversely affect Amgen or ChemoCentryx or the
expected benefits of the proposed transaction); regulatory actions
or delays or government regulation generally, including potential
regulatory actions or delays relating to the completion of the
potential transaction; the occurrence of any event, change or other
circumstance that could give rise to the right of Amgen or
ChemoCentryx to terminate the definitive merger agreement governing
the terms and conditions of the proposed transaction; effects of
the announcement, pendency or consummation of the proposed
transaction on ChemoCentryx's ability to retain and hire key
personnel, its ability to maintain relationships with its
customers, suppliers and others with whom it does business, its
business generally or its stock price; risks related to the
diversion of management's attention from ongoing business
operations and opportunities; the risk that stockholder litigation
in connection with the proposed transaction may result in
significant costs of defense, indemnification and liability; the
potential that the strategic benefits, synergies or opportunities
expected from the proposed transaction may not be realized or may
take longer to realize than expected; the successful integration of
ChemoCentryx into Amgen subsequent to the closing of the proposed
transaction and the timing, difficulty and cost of such
integration; the possibility that the proposed transaction may be
more expensive to complete than anticipated, including as a result
of unexpected factors or events; and other risks and factors
referred to from time to time in Amgen's and ChemoCentryx's filings
with the Securities and Exchange Commission, including Amgen's
Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly
Reports on Form 10-Q and ChemoCentryx's Annual Report on Form 10-K
for the year ended December 31, 2021
and subsequent Quarterly Reports on Form 10-Q, including those
related to the uncertainties inherent in the research and
development of new and existing healthcare products, including
clinical and regulatory developments and additional analysis of
existing clinical data; our ability to obtain or maintain
proprietary intellectual property protection; safety, quality or
manufacturing issues or delays; changes in expected or existing
competition; and domestic and global trends toward health care cost
containment, including government, payor and general public pricing
and reimbursement pressures. The effects of the COVID-19 pandemic
may give rise to risks that are currently unknown or amplify the
risks associated with many of these factors. Amgen is providing the
information in this communication as of this date and does not
undertake any obligation to update any forward-looking statements
as a result of new information, future events or otherwise.
Amgen, Thousand Oaks
Jessica Akopyan, 805-440-5721
(media)
Arvind Sood, 805-447-1060
(investors)
ChemoCentryx, San Carlos
Bill Slattery, Jr., 650-210-2970
(media/investors)
View original content to download
multimedia:https://www.prnewswire.com/news-releases/amgen-to-acquire-chemocentryx-for-4-billion-in-cash-301599672.html
SOURCE Amgen