THOUSAND OAKS, Calif. and
SOUTH SAN FRANCISCO, Calif.,
Aug. 25, 2013 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) today
announced that their Boards of Directors have unanimously approved
a transaction under which Amgen will acquire all of the outstanding
shares of Onyx for $125 per share in
cash. The purchase price is $10.4
billion, or $9.7 billion net
of estimated Onyx cash.
Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company
engaged in the development and commercialization of innovative
therapies for improving the lives of people with cancer. Onyx
has an important and growing multiple myeloma franchise, with
Kyprolis® (carfilzomib) for Injection already approved
in the United States (U.S.). In
addition, Onyx has three partnered oncology assets:
Nexavar® (sorafenib) tablets (an Onyx and Bayer
HealthCare Pharmaceuticals, Inc. compound), Stivarga®
(regorafenib) tablets (a Bayer compound), and palbociclib (a
Pfizer, Inc. compound). Onyx also has multiple oncology
compounds in various stages of clinical development.
Amgen intends to effect the transaction through a tender offer
and expects to close at the beginning of the fourth quarter,
subject to the satisfaction of customary closing conditions,
including the receipt of regulatory clearance.
"We believe that Amgen is ideally suited to realize the full
potential of Onyx's portfolio and pipeline for the benefit of
physicians and patients," said Robert A.
Bradway, chairman and chief executive officer at
Amgen. "Our acquisition of Onyx follows a thorough due
diligence process and is fully consistent with our strategy of
advancing innovative medicines that address serious unmet medical
needs. We expect this acquisition will accelerate
growth and enhance value for Amgen shareholders.
"Amgen has a unique opportunity to add value to Kyprolis, a
product which is at an early and promising stage of its launch,"
Bradway continued.
Onyx holds global rights to Kyprolis, excluding Japan.
Kyprolis has an orphan drug designation in the U.S. with
exclusivity until July 2019, and
patents in the U.S. which extend until at least 2025.
Amgen will benefit from the global rights to Onyx's innovative
oncology portfolio and pipeline. Amgen intends to leverage
its oncology capabilities and experience to support Onyx's clinical
development programs and maximize Kyprolis' potential in the U.S.
and the rest of the world.
The acquisition of Onyx also adds to Amgen's robust late-stage
pipeline. This pipeline includes nine innovative products for
which registration-enabling data are anticipated by 2016.
Four of these are innovative, first-in class
oncology products. Onyx's pipeline complements Amgen's growing
oncology portfolio.
In addition to accelerating Amgen's revenue growth, the
acquisition of Onyx is expected to be accretive to Amgen's adjusted
net income in 2015.
"After a careful and thorough evaluation process, our Board of
Directors has determined that the all-cash transaction with Amgen
maximizes value for our stockholders and expands the potential of
our commercial medicines and clinical pipeline to reach more
patients globally," said Dr. Tony
Coles, chairman and chief executive officer of
Onyx.
Coles continued, "We are pleased to have reached this agreement
with Amgen, a company that shares Onyx's vision for innovation on
behalf of patients. This transaction is an important
affirmation of the meaningful value our employees have created, and
we look forward to rewarding our stockholders with an immediate and
attractive premium."
Bradway concluded, "Our two companies share a strong culture of
innovation and a focus on patient needs. I look forward to bringing
the talented people of Onyx and Amgen together as we continue to
fulfill our commitment to unlocking the potential of biology for
patients suffering from serious illnesses."
Benefits of the Transaction
Excellent Strategic Fit: Amgen's strategy is to
advance innovative medicines that address serious unmet medical
needs.
- Amgen is a global leader in oncology. As a focused oncology
company, Onyx's products and pipeline strengthen Amgen's leading
position in this field.
- Onyx's oncology pipeline adds to Amgen's existing pipeline that
addresses areas of serious unmet medical need. Amgen's current
pipeline includes nine products for which registration-enabling
data are anticipated by 2016.
- The acquisition of Onyx enables Amgen to continue building its
position in international markets, capitalizing on its worldwide
commercial, development and manufacturing capabilities. Onyx has
global rights to Kyprolis (excluding Japan) and has clinical trials underway
supporting an expected European Union (EU) filing in 2014.
- Amgen's track record in quality and reliability of supply and
efficiency in manufacturing will bring an added source of value to
the Onyx portfolio.
- The transaction is expected to deliver meaningful revenue
growth and return on capital and to be accretive to adjusted net
income in 2015. This will support Amgen's commitment to continue to
meaningfully increase its dividend over time.
Positions Amgen to Address Growing Patient Needs in Multiple
Myeloma
- Kyprolis is at an early stage of its launch, with global
rights, excluding Japan, held by
Onyx. It has an orphan drug designation in the U.S. with
exclusivity until July 2019, and
patents in the U.S. which extend until at least 2025. Amgen
believes there is a significant opportunity to grow Kyprolis,
including potential expansion into earlier lines of multiple
myeloma treatment and into international markets.
Ongoing studies to support and extend Kyprolis' position in
multiple myeloma include:
-
- The ASPIRE trial, which is investigating the addition of
Kyprolis to Revlimid® (lenalidomide)1 and
dexamethasone in patients with relapsed multiple myeloma who have
received one to three prior therapies. An interim analysis is
expected to read out in 2014. ASPIRE is the confirmatory trial for
full U.S. approval as well as a registration-enabling study for
relapsed multiple myeloma in the U.S. and EU.
- The FOCUS trial, which could support the EU filing for the
indication of relapsed/refractory multiple myeloma, is also
expected to read out in 2014.
- The ENDEAVOR trial, underway to compare Kyprolis to
Velcade® (bortezomib)2 in patients with
relapsed multiple myeloma who have received one to three prior
therapies.
- The CLARION trial, underway to compare Kyprolis to Velcade in
patients with newly diagnosed multiple myeloma.
- Oprozomib, an investigational oral proteasome inhibitor,
is in Phase 1b/2 trials and has the potential to play an important
future role in the management of multiple myeloma.
- Across the multiple myeloma platform, Amgen's experience in
oncology can help guide Onyx's pipeline to successful approval and
reimbursement.
Provides Additional Sources of Revenue Growth and
Profitability
- Nexavar® (sorafenib)
tablets is Onyx and Bayer's oral kinase inhibitor, currently
approved in the U.S. for unresectable hepatocellular carcinoma
(HCC) and advanced renal cell carcinoma (RCC). It is being studied
in locally advanced or metastatic HER2 negative breast cancer.
Nexavar has also been submitted for U.S. Food and Drug
Administration (FDA) and European Medicines Agency (EMA) approval
for the treatment of radioactive iodine-refractory differentiated
thyroid cancer. Nexavar is co-developed by Onyx and Bayer
except in Japan where Bayer
manages all development. The companies co-promote Nexavar in the
U.S. Outside of the U.S., Bayer has exclusive marketing rights, and
Bayer and Onyx share profits globally, excluding Japan.
- Stivarga® (regorafenib) tablets is
Bayer's oral multiple kinase inhibitor, currently approved in the
U.S. for the treatment of patients with metastatic colorectal
cancer (mCRC) who have been previously treated with
fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy,
an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR
therapy. It is also indicated for the treatment of patients with
locally advanced, unresectable or metastatic gastrointestinal
stromal tumor (GIST) who have been previously treated with imatinib
mesylate and sunitinib malate. Stivarga is a Bayer compound
developed by Bayer and jointly promoted by Bayer and Onyx in the
U.S. In 2011, Bayer entered into an agreement with Onyx, under
which Onyx receives a 20 percent royalty on all global net sales of
Stivarga in oncology.
- Palbociclib is Pfizer's investigational oral, small
molecule cyclin-dependent kinase 4/6 inhibitor being developed by
Pfizer in a Phase 3 trial for ER+, HER2-negative advanced breast
cancer. Palbociclib has received Breakthrough Therapy
designation by the U.S. FDA based on preliminary Phase 2 data
showing improvement in median progression-free survival in
combination therapy. Onyx will receive an 8 percent royalty
on future worldwide sales of palbociclib.
Financing and Approvals
Amgen will finance the
acquisition with $8.1 billion in
committed bank loans and the balance with cash available in
the U.S. The loans have five year terms and carry an
average interest charge of LIBOR plus 104 basis points. Amgen
expects to retain its investment grade credit rating following this
transaction and remains committed to meaningfully increasing the
dividend over time. The transaction is subject to the
expiration or termination of the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act and other customary
closing conditions.
Lazard is acting as lead advisor to Amgen; BofA Merrill
Lynch is acting as co-advisor and is also lead arranger for the
financing; and Sullivan & Cromwell LLP is serving as legal
counsel. Centerview Partners, LLC is acting as financial
advisor to Onyx and Goodwin Procter,
LLP is serving as legal counsel.
Investor Conference Call / Webcast Information
Amgen
will host a conference call and webcast at 8:30 a.m. EDT (5:30 a.m.
PDT), on Monday, Aug. 26 to
provide more information on this announcement. The webcast
and accompanying slides can be accessed at www.amgen.com. A
real-time and post-call webcast will be available for 7 days
following the call under the Investor section of
www.amgen.com.
Conference Call
Dial-in:
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Domestic:
|
877-456-7504
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International:
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706-643-3140
|
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Passcode:
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40362332
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Replay
Dial-in:
|
Domestic:
|
855-859-2056
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International:
|
404-537-3406
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Passcode:
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40362332
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About Kyprolis® (carfilzomib) for
Injection
Kyprolis® (carfilzomib) for Injection,
a proteasome inhibitor, is approved for the treatment of patients
with multiple myeloma who have received at least two prior
therapies, including bortezomib and an immunomodulatory agent, and
have demonstrated disease progression on or within 60 days of
completion of the last therapy. Approval is based on response
rate. Currently, no data are available for Kyprolis that
demonstrate an improvement in progression-free survival or overall
survival.
Important Safety Information Regarding Kyprolis® (carfilzomib)
for Injection
On July 20, 2012, the U.S. Food
and Drug Administration (FDA) granted accelerated approval of
Kyprolis® (carfilzomib) for Injection for the treatment of patients
with multiple myeloma who have received at least two prior
therapies including bortezomib and an immunomodulatory agent
(IMiD), and have demonstrated disease progression on or within 60
days of completion of the last therapy. Approval was based on
response rate. Clinical benefit, such as improvement in survival or
symptoms, has not been verified.
Safety data have been evaluated in 526 patients with relapsed
and/or refractory multiple myeloma who received single-agent
Kyprolis. There were 37 deaths in the phase 2 studies, or 7% of
patients. The most common causes of death, other than disease
progression, were cardiac (5 patients), end-organ failure (4
patients), and infection (4 patients). Important warnings and
precautions include cardiac arrest, congestive heart failure,
myocardial ischemia; pulmonary hypertension, pulmonary
complications, infusion reactions, tumor lysis syndrome,
thrombocytopenia, hepatic toxicity and embryo-fetal toxicity.
Death due to cardiac arrest has occurred within a day of
Kyprolis administration. Patients with New York Heart Association
Class III and IV heart failure, myocardial infarction in the
preceding 6 months, and conduction abnormalities uncontrolled by
medications were not eligible for the clinical trials. These
patients may be at greater risk for cardiac complications.
Pulmonary arterial hypertension (PAH) was reported in 2% of
patients treated with Kyprolis and was Grade 3 or greater in less
than 1% of patients. Dyspnea was reported in 35% of patients
enrolled in clinical trials. Grade 3 dyspnea occurred in 5%; no
Grade 4 events, and 1 death (Grade 5) was reported.
Infusion reactions, characterized by a spectrum of systemic
symptoms including fever, chills, arthralgia, myalgia, facial
flushing, facial edema, vomiting, weakness, shortness of breath,
hypotension, syncope, chest tightness, or angina can occur
immediately following or up to 24 hours after administration of
Kyprolis. Administration of dexamethasone prior to Kyprolis reduces
the incidence and severity of reactions. Tumor lysis syndrome (TLS)
occurred following Kyprolis administration in < 1% of patients.
Patients with multiple myeloma and a high tumor burden should be
considered to be at greater risk for TLS.
Thrombocytopenia following Kyprolis administration resulted in a
dose reduction in 1% of patients and discontinuation of treatment
with Kyprolis in < 1% of patients.
Cases of hepatic failure, including fatal cases, have been
reported (< 1%). Kyprolis can cause elevations of serum
transaminases and bilirubin.
There are no adequate and well-controlled studies in pregnant
women using Kyprolis. Females of reproductive potential should be
advised to avoid becoming pregnant while being treated with
Kyprolis.
The most common serious adverse reactions were pneumonia, acute
renal failure, pyrexia, and congestive heart failure. The most
common adverse reactions (incidence of 30% or greater) observed in
clinical trials of patients with multiple myeloma were fatigue,
anemia, nausea, thrombocytopenia, dyspnea, diarrhea, and pyrexia.
Serious adverse reactions were reported in 45% of patients.
Full prescribing information is available at
http://www.onyx.com.
About Nexavar® (sorafenib)
Tablets
Nexavar is approved in the U.S. for the treatment of
patients with unresectable hepatocellular carcinoma and for the
treatment of patients with advanced renal cell carcinoma. Nexavar
is thought to inhibit both the tumor cell and tumor vasculature. In
in vitro studies, Nexavar has been shown to inhibit multiple
kinases thought to be involved in both cell proliferation (growth)
and angiogenesis (blood supply) – two important processes that
enable cancer growth. These kinases include Raf kinase, VEGFR-1,
VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.
Nexavar is currently approved in more than 100 countries.
Nexavar is also being evaluated by Bayer and Onyx, international
study groups, government agencies and individual investigators in a
range of cancers.
Important Safety Considerations For Nexavar® (sorafenib)
Tablets
Nexavar in combination with carboplatin and paclitaxel is
contraindicated in patients with squamous cell lung cancer.
Cardiac ischemia and/or myocardial infarction may occur.
Temporary or permanent discontinuation of Nexavar should be
considered in patients who develop cardiac ischemia and/or
myocardial infarction.
An increased risk of bleeding may occur following Nexavar
administration. If bleeding necessitates medical intervention,
consider permanent discontinuation of Nexavar.
Hypertension may occur early in the course of treatment. Monitor
blood pressure weekly during the first 6 weeks and periodically
thereafter and treat, if required.
Hand-foot skin reaction and rash are common and management may
include topical therapies for symptomatic relief. In cases of any
severe or persistent adverse reactions, temporary treatment
interruption, dose modification, or permanent discontinuation of
Nexavar should be considered. Nexavar should be discontinued if
Stevens-Johnson Syndrome or toxic epidermal necrolysis are
suspected as these may be life threatening.
Gastrointestinal perforation was an uncommon adverse reaction
and has been reported in less than 1% of patients taking Nexavar.
Discontinue Nexavar in the event of a gastrointestinal
perforation.
Patients taking concomitant warfarin should be monitored
regularly for changes in prothrombin time (PT), International
Normalized Ratio (INR) or clinical bleeding episodes.
Temporary interruption of Nexavar therapy is recommended in
patients undergoing major surgical procedures.
Nexavar in combination with gemcitabine/cisplatin is not
recommended in patients with squamous cell lung cancer. The safety
and effectiveness of Nexavar has not been established in patients
with non-small cell lung cancer.
Nexavar can prolong the QT/QTc interval and increase the risk
for ventricular arrhythmias. Avoid use in patients with congenital
long QT syndrome and monitor patients with congestive heart
failure, bradyarrhythmias, drugs known to prolong the QT interval,
and electrolyte abnormalities.
Drug-induced hepatitis with Nexavar may result in hepatic
failure and death. Liver function tests should be monitored
regularly and in cases of increased transaminases without
alternative explanation Nexavar should be discontinued.
Nexavar may cause fetal harm when administered to a pregnant
woman. Women of childbearing potential should be advised to avoid
becoming pregnant while on Nexavar and female patients should also
be advised against breastfeeding while receiving Nexavar.
Elevations in serum lipase and reductions in serum phosphate of
unknown etiology have been associated with Nexavar.
Avoid concomitant use of strong CYP3A4 inducers, when possible,
because inducers can decrease the systemic exposure of Nexavar.
Nexavar exposure decreases when coadministered with oral neomycin.
Effects of other antibiotics on Nexavar pharmacokinetics have not
been studied.
Most common adverse reactions reported for Nexavar-treated
patients vs. placebo-treated patients in unresectable HCC,
respectively, were: diarrhea (55% vs. 25%), fatigue (46% vs. 45%),
abdominal pain (31% vs. 26%), weight loss (30% vs. 10%), anorexia
(29% vs. 18%), nausea (24% vs. 20%), and hand-foot skin reaction
(21% vs. 3%). Grade 3/4 adverse reactions were 45% vs. 32%.
Most common adverse reactions reported for Nexavar-treated
patients vs. placebo-treated patients in advanced RCC,
respectively, were: diarrhea (43% vs. 13%), rash/desquamation (40%
vs. 16%), fatigue (37% vs. 28%), hand-foot skin reaction (30% vs.
7%), alopecia (27% vs. 3%), and nausea (23% vs. 19%). Grade 3/4
adverse reactions were 38% vs. 28%.
For information about Nexavar including U.S. Nexavar prescribing
information, visit www.nexavar-us.com or call 1.866.NEXAVAR
(1.866.639.2827).
Nexavar® is a registered trademark of Bayer
HealthCare Pharmaceuticals, Inc.
About Stivarga (regorafenib)
In the United States, Stivarga is indicated for
the treatment of patients with mCRC who have been previously
treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based
chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an
anti-EGFR therapy. It is also indicated for the treatment of
patients with locally advanced, unresectable or metastatic
gastrointestinal stromal tumor (GIST) who have been previously
treated with imatinib mesylate and sunitinib malate.
Stivarga is an inhibitor of multiple kinases involved in normal
cellular functions and in pathologic processes such as oncogenesis,
tumor angiogenesis, and maintenance of the tumor
microenvironment.
For full U.S. prescribing information, including BOXED WARNING,
visit www.stivarga-us.com.
Important U.S. Safety Information for Stivarga® (regorafenib)
Tablets
WARNING: HEPATOTOXICITY
Severe and sometimes fatal hepatotoxicity has been observed in
clinical trials.
Monitor hepatic function prior to and during treatment.
Interrupt and then reduce or discontinue STIVARGA for
hepatotoxicity as manifested by elevated liver function tests or
hepatocellular necrosis, depending upon severity and
persistence.
Severe drug-induced liver injury with fatal outcome occurred in
0.3% of 1200 STIVARGA-treated patients across all clinical trials.
In metastatic colorectal cancer (mCRC), fatal hepatic failure
occurred in 1.6% of patients in the STIVARGA arm and in 0.4% of
patients in the placebo arm; all the patients with hepatic failure
had metastatic disease in the liver. In gastrointestinal stromal
tumor (GIST), fatal hepatic failure occurred in 0.8% of patients in
the STIVARGA arm.
Obtain liver function tests (ALT, AST, and bilirubin) before
initiation of STIVARGA and monitor at least every 2 weeks during
the first 2 months of treatment. Thereafter, monitor monthly or
more frequently as clinically indicated. Monitor liver function
tests weekly in patients experiencing elevated liver function tests
until improvement to less than 3 times the upper limit of normal
(ULN) or baseline values. Temporarily hold and then reduce or
permanently discontinue STIVARGA, depending on the severity and
persistence of hepatotoxicity as manifested by elevated liver
function tests or hepatocellular necrosis.
STIVARGA caused an increased incidence of hemorrhage. The
overall incidence (Grades 1-5) was 21% and 11% with STIVARGA vs 8%
and 3% with placebo in mCRC and GIST patients, respectively. Fatal
hemorrhage occurred in 4 of 632 (0.6%) STIVARGA-treated patients
and involved the respiratory, gastrointestinal, or genitourinary
tracts. Permanently discontinue STIVARGA in patients with severe or
life-threatening hemorrhage and monitor INR levels more frequently
in patients receiving warfarin.
STIVARGA caused an increased incidence of hand-foot skin
reaction (HFSR) (also known as palmar-plantar erythrodysesthesia
[PPE]) and severe rash, frequently requiring dose modification. The
overall incidence was 45% and 67% with STIVARGA vs 7% and 12% with
placebo in mCRC and GIST patients, respectively. Incidence of Grade
3 HFSR (17% vs 0% in mCRC and 22% vs 0% in GIST), Grade 3 rash (6%
vs <1% in mCRC and 7% vs 0% in GIST), serious adverse reactions
of erythema multiforme (0.2% vs 0% in mCRC), and Stevens-Johnson
syndrome (0.2% vs 0% in mCRC) was higher in STIVARGA-treated
patients. Toxic epidermal necrolysis occurred in 0.17% of 1200
STIVARGA-treated patients across all clinical trials. Withhold
STIVARGA, reduce the dose, or permanently discontinue depending on
the severity and persistence of dermatologic toxicity.
STIVARGA caused an increased incidence of hypertension (30% vs
8% in mCRC and 59% vs 27% in GIST with STIVARGA vs placebo,
respectively). Hypertensive crisis occurred in 0.25% of 1200
STIVARGA-treated patients across all clinical trials. Do not
initiate STIVARGA until blood pressure is adequately controlled.
Monitor blood pressure weekly for the first 6 weeks of treatment
and then every cycle, or more frequently, as clinically indicated.
Temporarily or permanently withhold STIVARGA for severe or
uncontrolled hypertension.
STIVARGA increased the incidence of myocardial ischemia and
infarction (1.2% with STIVARGA vs 0.4% with placebo). Withhold
STIVARGA in patients who develop new or acute cardiac ischemia or
infarction, and resume only after resolution of acute cardiac
ischemic events if the potential benefits outweigh the risks of
further cardiac ischemia.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
occurred in 1 of 1200 STIVARGA-treated patients across all clinical
trials. Confirm the diagnosis of RPLS with MRI and discontinue
STIVARGA in patients who develop RPLS.
Gastrointestinal perforation or fistula occurred in 0.6% of 1200
patients treated with STIVARGA across clinical trials. In GIST,
2.1% (4/188) of STIVARGA-treated patients developed
gastrointestinal fistula or perforation: of these, 2 cases of
gastrointestinal perforation were fatal. Permanently discontinue
STIVARGA in patients who develop gastrointestinal perforation or
fistula.
Treatment with STIVARGA should be stopped at least 2 weeks prior
to scheduled surgery. Resuming treatment after surgery should be
based on clinical judgment of adequate wound healing. STIVARGA
should be discontinued in patients with wound dehiscence.
STIVARGA can cause fetal harm when administered to a pregnant
woman. Use effective contraception during treatment and up to 2
months after completion of therapy. If this drug is used during
pregnancy, or if the patient becomes pregnant while taking this
drug, the patient should be apprised of the potential hazard to the
fetus.
Because many drugs are excreted in human milk and because of the
potential for serious adverse reactions in nursing infants from
STIVARGA, a decision should be made whether to discontinue nursing
or discontinue the drug, taking into account the importance of the
drug to the mother.
The most frequently observed adverse drug reactions (≥30%) in
STIVARGA-treated patients vs placebo-treated patients in mCRC,
respectively, were: asthenia/fatigue (64% vs 46%), decreased
appetite and food intake (47% vs 28%), HFSR/PPE (45% vs 7%),
diarrhea (43% vs 17%), mucositis (33% vs 5%), weight loss (32% vs
10%), infection (31% vs 17%), hypertension (30% vs 8%), and
dysphonia (30% vs 6%).
The most frequently observed adverse drug reactions (≥30%) in
STIVARGA-treated patients vs placebo-treated patients in GIST,
respectively, were: HFSR/PPE (67% vs 15%), hypertension (59% vs
27%), asthenia/fatigue (52% vs 39%), diarrhea (47% vs 9%),
mucositis (40% vs 8%), dysphonia (39% vs 9%), infection (32% vs
5%), decreased appetite and food intake (31% vs 21%), and rash (30%
vs 3%).
STIVARGA® is a trademark of Bayer®.
Bayer® and the Bayer Cross®
are registered trademarks of Bayer.
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 the world's
largest independent biotechnology company, 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.
About Onyx
Based in South
San Francisco, California, Onyx Pharmaceuticals, Inc. is a
global biopharmaceutical company engaged in the development and
commercialization of innovative therapies for improving the lives
of people with cancer. The company is focused on developing novel
medicines that target key molecular pathways. For more information
about Onyx, visit the company's website at www.onyx.com. Onyx
Pharmaceuticals is on Twitter. Sign up to follow our Twitter feed
@OnyxPharm at http://twitter.com/OnyxPharm.
Amgen Forward-Looking Statements
This news release
contains forward-looking statements that are based on Amgen'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 statements about the planned completion of the tender
offer and the merger, 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 Amgen's business. Unless otherwise noted,
Amgen is providing this information as of August 25, 2013, 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.
Risks and uncertainties include whether the proposed transaction
described in this press release can be completed in a timely
manner, and whether the anticipated benefits of the proposed
transaction can be achieved. 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 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,
joint ventures and acquisitions. Product candidates
that are derived from relationships or acquisitions 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, it 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 routinely obtains patents
for its products and technology, the protection offered by its
patents and patent applications may be challenged, invalidated or
circumvented by its competitors and there can be no guarantee of
Amgen's ability to obtain or maintain patent protection for its
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.
The scientific information discussed in this news release
related to 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. Only the FDA can determine whether the
product candidates are safe and effective for the use(s) being
investigated. Further, the scientific information discussed in this
news release relating to new indications for products is
preliminary and investigative and is not part of the labeling
approved by the U.S. Food and Drug Administration (FDA) for the
products. The products are not approved for the
investigational use(s) discussed in this news release, and no
conclusions can or should be drawn regarding the safety or
effectiveness of the products for these uses. Only the FDA
can determine whether the products are safe and effective for these
uses. Healthcare professionals should refer to and rely upon the
FDA-approved labeling for the products, and not the information
discussed in this news release.
Onyx Forward-Looking Statements
This news release
contains "forward-looking statements" of Onyx within the meaning of
the federal securities laws. These forward-looking statements
include, without limitation, statements regarding the expected
timing of the completion of the transaction, Amgen's operation of
the Onyx business following completion of the transaction, and
statements regarding the future operation, the anticipated growth
of our business, global expansion and increases to our
international capabilities, our launch of Kyprolis in the United States, our investments in Phase 3
clinical trials, contributions from our kinase inhibitor business
and future cost of goods sold with respect to Kyprolis. These
statements are subject to risks and uncertainties that could cause
actual results and events to differ materially from those
anticipated, including, but not limited to, risks and uncertainties
related to: uncertainties as to the timing of the
transaction; uncertainties as to the percentage of Onyx
stockholders tendering their shares in the offer; the possibility
that competing offers will be made; the possibility that various
closing conditions for the transaction may not be satisfied or
waived, including that a governmental entity may prohibit, delay or
refuse to grant approval for the consummation of the transaction;
the effects of disruption caused by the transaction making it more
difficult to maintain relationships with employees, collaborators,
vendors and other business partners; the risk that stockholder
litigation in connection with the transaction may result in
significant costs of defense, indemnification and liability;
Nexavar® (sorafenib) tablets, Kyprolis® (carfilzomib) for Injection
and Stivarga® (regorafenib) tablets being the only approved
products from which we may obtain revenue; competition; failures or
delays in our clinical trials or the regulatory process; dependence
on our collaborative relationship with Bayer; supply of Nexavar,
Stivarga or Kyprolis; market acceptance and the rate of adoption of
Nexavar, Stivarga and Kyprolis; pharmaceutical pricing and
reimbursement pressures; serious adverse side effects, if they are
associated with Nexavar, Stivarga or Kyprolis; government
regulation; possible failure to realize the anticipated benefits of
business acquisitions or strategic investments; protection of our
intellectual property; and product liability risks; and other risks
and uncertainties discussed in Onyx's filings with the Securities
and Exchange Commission (the "Commission"), including the "Risk
Factors" sections of Onyx's most recent annual report on Form 10-K
and subsequent quarterly reports on Form 10-Q, as well as the
tender offer documents to be filed by Arena Acquisition
Corporation, a wholly owned subsidiary of Amgen, and the
Solicitation/Recommendation Statement to be filed by Onyx. Onyx
undertakes no obligation to update any forward-looking statements
as a result of new information, future developments or otherwise,
except as expressly required by law.
Additional Information
The tender offer described in
this communication (the "Offer") has not yet commenced, and this
communication is neither an offer to purchase nor a solicitation of
an offer to sell any shares of the common stock of Onyx
Pharmaceuticals, Inc. or any other securities. On the commencement
date of the Offer, a tender offer statement on Schedule TO,
including an offer to purchase, a letter of transmittal and related
documents, will be filed with the United States Securities and
Exchange Commission (the "SEC") by Amgen and a
Solicitation/Recommendation Statement on Schedule 14D-9 will be
filed with the SEC by Onyx. The offer to purchase shares of Onyx
common stock will only be made pursuant to the offer to purchase,
the letter of transmittal and related documents filed as a part of
the Schedule TO. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ
BOTH THE TENDER OFFER STATEMENT AND THE SOLICITATION/RECOMMENDATION
STATEMENT REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO
TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION. The tender offer statement will be filed
with the SEC by Amgen and Arena Acquisition Company, a wholly owned
subsidiary of Amgen, and the solicitation/recommendation statement
will be filed with the SEC by Onyx. Investors and security holders
may obtain a free copy of these statements (when available) and
other documents filed with the SEC at the website maintained by the
SEC at www.sec.gov or by directing such requests to the Information
Agent for the tender offer which will be named in the tender offer
statement.
1 Revlimid® is a registered trademark of
Celgene Corporation.
2 Velcade® is a registered trademark of
Millennium Pharmaceuticals, Inc.
Contact:
Amgen
Christine Regan,
805-447-5476 (media)
Arvind Sood, 805-447-1060
(investors)
Onyx
Lori Melancon,
650-266-2394 (media)
Amy Figueroa, 650-266-2398
(investors)
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SOURCE Amgen