THOUSAND OAKS, Calif.--(BUSINESS WIRE)--April 19, 2007--Amgen
(NASDAQ: AMGN) today announced the results of the "145 study", a
randomized, double-blind, placebo-controlled, multicenter Phase 3
study of Aranesp(R) (darbepoetin alfa) in 600 previously untreated
patients with extensive-stage small-cell lung cancer (SCLC) receiving
platinum-containing chemotherapy. The study demonstrated no
statistically significant difference in risk of death (overall
survival Aranesp compared to placebo Hazard Ratio (HR): 0.93, 95% CI:
0.78 to 1.11) or investigator determined progression-free survival
(HR: 1.02, 95% CI: 0.86 to 1.21).
The study demonstrated a significant change in hemoglobin
concentration from baseline in favor of Aranesp (a co-primary
endpoint). Aranesp-treated patients also experienced a significantly
lower risk of blood transfusions (HR: 0.40, 95% CI: 0.29 to 0.55). The
overall safety profile, including thromboembolic events, was
consistent with that described in the U.S. label.
"The 145 study is a component of Amgen´s ongoing pharmacovigilance
program designed to evaluate the effect of Aranesp on long-term
survival in patients with chemotherapy-induced anemia. This study had
higher initiation and maintenance hemoglobin targets (Hb less than or
equal to 13 g/dl) than in the U.S. label," said Roger M. Perlmutter,
M.D., Ph.D., executive vice president of Research and Development at
Amgen. "These results contribute to the growing body of evidence on
ESA safety, reinforcing the neutral impact of ESAs on survival in
cancer patients suffering from chemotherapy-induced anemia."
Amgen initiated the SCLC study in 2002 after results from a
previous Phase 3 study showed a trend towards improved survival in
patients with lung cancer. The 145 study was designed to evaluate
whether increasing or maintaining hemoglobin concentrations with
Aranesp, when administered with platinum-containing chemotherapy in
patients with previously untreated extensive-stage SCLC, increased
In this study, patients were randomized 1:1 to receive Aranesp 300
mcg or placebo every week (QW) for the first 4 weeks, followed by once
every three week (Q3W) dosing (commencing on week 5) for the remainder
of the 24-week treatment period. Patients were treated to a target Hb
of 13 g/dL, which is higher than indicated by the FDA-approved product
label, with dose withholding at 14 g/dL.
Conference Call Information
Amgen will discuss the results of the 145 study during a
conference call to review the Company´s first quarter financial
results with the investment community at 2:00 PM, Pacific Time,
Monday, April 23, 2007. Live audio of the conference call will be
simultaneously broadcast over the Internet and will be available to
members of the news media, investors and the general public. The
conference call, including the question and answer session, is
expected to last approximately one hour.
The webcast of the conference, as with other selected
presentations regarding developments in Amgen´s business given by
management at certain investor and medical conferences, can be found
on Amgen´s Web site, www.amgen.com, under Investors. Information
regarding presentation times, webcast availability, and webcast links
are noted on Amgen´s Investor Relations Events Calendar. The webcast
will be archived and available for replay 72 hours after the event.
Aranesp was approved by the U.S. Food and Drug Administration
(FDA) in September 2001 for the treatment of anemia associated with
chronic renal failure (CRF), also known as chronic kidney disease
(CKD), for patients on dialysis and patients not on dialysis. In July
2002, the FDA approved weekly dosing of Aranesp for the treatment of
anemia in patients with nonmyeloid malignancies where anemia is due to
the effect of concomitantly administered chemotherapy, and in March
2006, the FDA approved every-three-week dosing in these patients.
Important Safety Information including boxed WARNING
Use the lowest dose of Aranesp that will gradually increase the
hemoglobin concentration to the lowest level sufficient to avoid the
need for red blood cell transfusion.
Aranesp and other erythropoiesis-stimulating agents (ESAs)
increased the risk for death and for serious cardiovascular events
when administered to target a hemoglobin of greater than 12 g/dL.
Cancer Patients: Use of ESAs
-- Shortened the time to tumor progression in patients with
advanced head and neck cancer receiving radiation therapy when
administered to target a hemoglobin of greater than 12 g/dL,
-- Shortened overall survival and increased deaths attributed to
disease progression at 4 months in patients with metastatic
breast cancer receiving chemotherapy when administered to
target a hemoglobin of greater than 12 g/dL,
-- Increased the risk of death when administered to target a
hemoglobin of 12 g/dL in patients with active malignant
disease receiving neither chemotherapy or radiation therapy.
ESAs are not indicated for this population.
Patients receiving ESAs pre-operatively for reduction of
allogeneic red blood cell transfusions: A higher incidence of deep
venous thrombosis was documented in patients receiving Epoetin alfa
who were not receiving prophylactic anticoagulation. Aranesp is not
approved for this indication.
Aranesp is contraindicated in patients with uncontrolled
hypertension. Aranesp and other erythropoietic therapies increase the
risk of serious arterial and venous thromboembolic events, including
myocardial infarction, stroke, congestive heart failure, and
hemodialysis graft occlusion. A rate of hemoglobin rise of greater
than 1 g/dL over 2 weeks may also contribute to these risks. To reduce
cardiovascular risks, the hemoglobin (Hb) concentration should not
exceed 12 g/dL, the rate of hemoglobin increase should not exceed 1
g/dL in any 2-week period.
Cases of pure red cell aplasia (PRCA) and of severe anemia, with
or without other cytopenias, associated with neutralizing antibodies
to erythropoietin have been reported in patients treated with Aranesp.
This has been reported predominantly in patients with CRF receiving
Aranesp by subcutaneous administration. A sudden loss of response to
Aranesp, accompanied by severe anemia and low reticulocyte count,
should be evaluated. If anti-erythropoietin antibody-associated anemia
is suspected, withhold Aranesp and other erythropoietic proteins.
Aranesp should be permanently discontinued in patients with
antibody-mediated anemia. Patients should not be switched to other
erythropoietic proteins as antibodies may cross-react.
The most commonly reported side effects in clinical trials in
patients with CRF were infection, hypertension, hypotension, myalgia,
headache, and diarrhea. The most commonly reported side effects in
clinical trials in patients with chemotherapy-induced anemia were
fatigue, edema, nausea, vomiting, diarrhea, fever and dyspnea.
The Aranesp prescribing information, including important safety
information and boxed warning, may be accessed at www.aranesp.com.
Amgen discovers, develops and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the
first companies to realize the new science´s promise by bringing safe
and effective medicines from lab, to manufacturing plant, to patient.
Amgen therapeutics have changed the practice of medicine, helping
millions of people around the world in the fight against cancer,
kidney disease, rheumatoid arthritis, and other serious illnesses.
With a deep and broad pipeline of potential new medicines, Amgen
remains committed to advancing science to dramatically improve
people´s lives. To learn more about our pioneering science and our
vital medicines, visit www.amgen.com.
This news release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed below
and others that can be found in Amgen´s Form 10-K for the year ended
December 31, 2006, and in Amgen´s periodic reports on Form 10-Q and
Form 8-K. 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 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
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 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 side effects or manufacturing problems with Amgen´s
products after they are on the market. In addition, sales of Amgen´s
products are affected by the availability of reimbursement and the
reimbursement policies imposed by third party payors, including
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may be affected by domestic and international trends toward managed
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legislation affecting pharmaceutical pricing and reimbursement.
Government regulations and reimbursement policies may affect the
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competes with other companies with respect to some of Amgen´s marketed
products as well as for the discovery and development of new products.
Amgen believes that some of the newer products, product candidates or
new indications for existing products, may face competition when and
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The scientific information discussed in this news release related
to our 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 our products is preliminary and investigative and is not part of
the labeling approved by the FDA for the products. The products are
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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
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CONTACT: Amgen, Thousand Oaks
Trish Hawkins, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)