Amgen to Discuss Benefits and Risks of ESA Treatment for Cancer Patients with Anemia Due to Chemotherapy at FDA ODAC Meeting
ESAs Provide Important Clinical Benefits to Cancer Patients With
Anemia Due to Chemotherapy; Ongoing and Planned Risk Management Will
Further Reduce Risks
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--March 13, 2008--Amgen Inc.
(NASDAQ: AMGN) will today present the benefits and risks of
Erythropoiesis-stimulating Agents (ESAs) in cancer patients with
anemia due to concomitantly administered chemotherapy at a meeting
with the U.S. Food and Drug Administration's (FDA) Oncologic Drugs
Advisory Committee (ODAC). ESAs provide these patients with the only
therapeutic alternative to red blood cell (RBC) transfusions, which
have known and uncertain risks.
"ESAs provide an unequivocal treatment benefit for cancer patients
undergoing chemotherapy by reducing the need for blood transfusions,"
said Roger M. Perlmutter, M.D., Ph.D., executive vice president, of
Research and Development at Amgen. "We look forward to discussing with
the ODAC a robust risk management program to reduce ESA risks while
still providing access and benefits to the appropriate patients."
For a complete review and analysis of Amgen's presentation to the
ODAC, Amgen's and FDA's briefing materials for the ODAC meeting are
available at www.Amgen.com or www.fda.gov.
Highlights of Amgen's presentation to the ODAC will include the
ESA Treatment Benefits
- ESAs provide the only therapeutic alternative to RBC
transfusions in cancer patients with anemia due to
concomitantly administered chemotherapy.
- In well-controlled clinical trials, ESAs have been proven to
reduce RBC transfusions in patients with anemia receiving
- If ESAs were not available, data from Amgen's
placebo-controlled clinical trials suggest that twice as many
patients receiving chemotherapy would require RBC
Risks of ESAs
- Eight ESA studies have shown safety signals when patients were
studied at higher than currently labeled hemoglobin targets
and/or for new experimental indications (such as radiotherapy
or patients not receiving chemotherapy).
- Six of these eight studies were discussed at ODAC meetings in
2004 and 2007. Since the May 2007 ODAC meeting, new data from
two studies have become available, including interim results
from the PREPARE (a study in neo-adjuvant breast cancer) and
long-term follow up data from GOG-191 (a study in cervical
cancer), both of which targeted hemoglobin levels higher than
in the current approved product label.
- These safety signals are inconsistently observed across a
total of 59 studies.
- The current label notes the hypothetical risks of shortened
overall survival and/or tumor progression when hemoglobin
targets are less than or equal to 12 g/dL.
- Potential mechanisms for these safety signals may include
thromboembolic events which have long been recognized in ESA
labeling. Other mechanisms include the recently labeled but
unproven hypothesis of tumor progression and reduced efficacy
of radiotherapy at high hemoglobin levels.
Amgen will review the totality of clinical evidence with ODAC,
including all favorable and unfavorable studies.
"Although these safety signals have been inconsistently observed
across a number of ESA studies, Amgen nonetheless takes them very
seriously, and is committed to conducting a controlled clinical trial
based on the current label to definitively address these issues," said
Perlmutter. "Patient safety is our top priority. To this end, we look
forward to the ODAC's recommendations on the proposed clinical study
and will continue to collaborate with the FDA, NCI and others to
address these safety concerns."
Risks of Blood Transfusions
The use of blood transfusions to treat anemia carries several
types of known and uncertain risks for patients with cancer and for
the public as a whole. Additionally, the benefits of RBC transfusions
are transient, requiring some patients to receive multiple
transfusions during the duration of their chemotherapy treatment.
- Although the blood supply is currently considered safer than
in the past, there are both known and unknown risks associated
- Blood transfusions also can be associated with transfusion
reactions or other antibody mediated problems.
- Physicians have stated that transfusions are disruptive for
patients, caregivers and physicians and divert substantial
resources that would otherwise be available for patient care.
Proposed Risk Management Program to Preserve Access and Minimize
Additional risk management, through additional product labeling
updates and a formal education and communication program, will
minimize risk while the necessary data are acquired from clinical
trials designed to address the unanswered safety questions. Amgen will
propose to the ODAC a risk program that is designed to minimize the
risks of ESA therapy, discourage off-label use, and promote educated
benefit-risk decisions for each patient.
Aranesp(R) (darbepoetin alfa) was approved by the FDA in September
2001 for the treatment of anemia associated with chronic renal failure
(CRF), for patients on dialysis and patients not on dialysis. In July
2002, the FDA approved weekly dosing of Aranesp for the treatment of
anemia caused by concomitantly administered chemotherapy in patients
with nonmyeloid malignancies and in March 2006, the FDA approved
every-three-week dosing in these patients.
Amgen launched EPOGEN(R) (Epoetin alfa), one of the first
biologically derived human therapeutics, into the U.S. medical
marketplace in 1989 for the treatment of anemia in patients with
chronic renal failure on dialysis. EPOGEN is a recombinant protein
with the same mechanism of action as endogenous human erythropoietin,
a protein produced by the kidneys to stimulate the production of
oxygen-transporting red blood cells.
Important Aranesp and EPOGEN Safety Information
WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and
THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION.
Renal failure: Patients experienced greater risks for death and
serious cardiovascular events when administered erythropoiesis-
stimulating agents (ESAs) to target higher versus lower hemoglobin
levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies.
Individualize dosing to achieve and maintain hemoglobin levels within
the range of 10 to 12 g/dL.
- ESAs shortened overall survival and/or time-to-tumor progression in
clinical studies in patients with breast, non-small cell lung, head
and neck, lymphoid, and cervical cancers when dosed to target a
hemoglobin of greater than or equal to 12 g/dL.
- The risks of shortened survival and tumor progression have not been
excluded when ESAs are dosed to target a hemoglobin of less than 12
- To minimize these risks, as well as the risk of serious cardio- and
thrombovascular events, use the lowest dose needed to avoid red blood
- Use only for treatment of anemia due to concomitant
- Discontinue following the completion of a chemotherapy course.
Perisurgery: EPOGEN(R) increased the rate of deep venous thromboses in
patients not receiving prophylactic anticoagulation. Consider deep
venous thrombosis prophylaxis.
Aranesp and EPOGEN are contraindicated in patients with
Amgen discovers, develops, manufactures 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.
Forward Looking Statement
This news release contains forward-looking statements that are
based on management'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 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 most recent 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 our business. Unless otherwise noted, Amgen is providing this
information as of March 13, 2008 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 we project. 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 us to complete clinical
trials and obtain regulatory approval for product marketing has in the
past varied and we expect similar variability in the future. We
develop 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 we may
have believed at the time of entering into such relationship. Also, we
or others could identify safety, side effects or manufacturing
problems with our products after they are on the market. Our business
may be impacted by government investigations, litigation and products
liability claims. We depend on third parties for a significant portion
of our manufacturing capacity for the supply of certain of our current
and future products and limits on supply may constrain sales of
certain of our current products and product candidate development.
In addition, sales of our products are affected by the
reimbursement policies imposed by third-party payors, 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 our products. In addition, we compete with other companies with
respect to some of our marketed products as well as for the discovery
and development of new products. We believe that some of our newer
products, product candidates or new indications for existing products,
may face competition when and as they are approved and marketed. Our
products may compete against products that have lower prices,
established reimbursement, superior performance, are easier to
administer, or that are otherwise competitive with our products. In
addition, 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 and there can be no guarantee of our ability to obtain or
maintain patent protection for our products or product candidates. We
cannot guarantee that we will be able to produce commercially
successful products or maintain the commercial success of our existing
products. Our stock price may be affected by actual or perceived
market opportunity, competitive position, and success or failure of
our products or product candidates. Further, 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.
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 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 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.
CONTACT: Amgen, Thousand Oaks
Ashleigh Koss: (213) 280-4030 (media)
John Shutter: (805) 447-1060 (investors)