THOUSAND OAKS, Calif.--(BUSINESS WIRE)--June 12, 2006--Amgen
(Nasdaq:AMGN), the world´s largest biotechnology company, today
announced that the U.S. Food and Drug Administration (FDA) has
accepted the Biologic License Application (BLA) for panitumumab, an
investigational fully human monoclonal antibody that targets the
epidermal growth factor receptor (EGFr) and has granted Priority
Review. The BLA was submitted for the treatment of metastatic
colorectal cancer patients who have failed prior chemotherapy,
including oxaliplatin and/or irinotecan containing regimens. A
Priority Review designation means that the FDA will target an Agency
action within six months of the application´s submission date.
Priority Review status is assigned by the FDA to those
applications the Agency has deemed to have the potential to provide a
significant therapeutic advance for patients. The rolling BLA
submission for panitumumab was initiated in December 2005 and
completed in March 2006. Panitumumab received Fast Track designation
from the FDA in July 2005. In April 2006, marketing applications were
submitted to the European Medicines Agency (EMEA) and Health Canada
and in May 2006 in Australia and Switzerland.
Patients and physicians can access www.amgentrials.com for more
information about ongoing panitumumab clinical trials.
Panitumumab is an investigational fully human monoclonal antibody
that targets the epidermal growth factor receptor (EGFr), a protein
that plays an important role in cancer cell signaling. Panitumumab, an
IgG2 monoclonal antibody, binds with high affinity to the EGFr.
Panitumumab was generated with XenoMouse(R) technology, which creates
a fully human monoclonal antibody that contains no murine (mouse)
protein. The body´s immune system can recognize the mouse protein
found in chimeric and humanized antibodies as foreign and may launch
an immune response. The goal of developing fully human monoclonal
antibodies is to offer effective targeted therapies with minimum risk
of immune response against these agents.
Panitumumab is being evaluated in clinical trials as both a
monotherapy and in combination with other agents for the treatment of
various types of cancer, including colorectal, lung and head and neck.
About the Epidermal Growth Factor Receptor (EGFr)
Although EGFr normally helps regulate the growth of many different
cells in the body, EGFr also can stimulate cancer cells to grow. In
fact, many cancer cells actually require signals mediated by EGFr for
their survival. Residing on the surface of these tumor cells, EGFr is
activated when naturally occurring proteins in the body, such as
epidermal growth factor (EGF) or transforming growth factor alpha
(TGF-alpha), bind to it. This binding changes the shape of EGFr,
which, in turn, triggers internal cellular signals that stimulate
tumor cell growth. Panitumumab binds to EGFr, preventing the natural
ligands such as EGF and TGF-alpha from binding to the receptor and
interfering with the signals that would otherwise stimulate growth of
the cancer cell and allow it to survive.
About Colorectal Cancer
Colorectal cancer is the third most common cancer diagnosed in men
and in women in the United States. The American Cancer Society
estimates that about 106,680 new cases of colon cancer and 41,930 new
cases of rectal cancer will be diagnosed in 2006.
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 broad and deep 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, 2005, 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
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 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
In addition, sales of Amgen´s products are affected by the
availability of reimbursement and the reimbursement policies imposed
by third party payors, including governments, private insurance plans
and managed care providers, and may be affected by domestic and
international trends toward managed care and healthcare cost
containment as well as possible U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government 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 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 as they are approved and
marketed. Amgen 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 Amgen routinely obtains patents for Amgen´s
products and technology, the protection offered by Amgen´s patents and
patent applications may be challenged, invalidated or circumvented by
Amgen´s competitors and there can be no guarantee of Amgen´s ability
to obtain or maintain patent protection for Amgen´s products or
product candidates. Amgen cannot guarantee that it will be able to
produce commercially successful products or maintain the commercial
success of Amgen´s existing products. Amgen´s stock price may be
affected by actual or perceived market opportunity, competitive
position, and success or failure of Amgen´s 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 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 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.
EDITOR´S NOTE: An electronic version of this news release may be
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Trish Hawkins, 805-447-4587 (media)
Arvind Sood, 805-447-1060 (investors)
SOURCE: Amgen Inc.