First EGFr Inhibitor to Demonstrate Improvement in Progression-Free
Survival as Monotherapy for Metastatic Colorectal Cancer Amgen
(Nasdaq:AMGN) and Abgenix, Inc. (Nasdaq:ABGX) today announced that
a pivotal Phase 3 study of panitumumab met the primary endpoint of
improving progression-free survival in patients with metastatic
colorectal cancer (mCRC) who had failed standard chemotherapy. In
this randomized Phase 3 trial involving 463 patients, those who
received panitumumab every two weeks showed a 46 percent decrease
in tumor progression rate versus those who received best supportive
care alone (p less than 0.000000001). This result exceeded the
pre-specified measure of progression-free survival that the trial
was designed to demonstrate (i.e., a 33 percent decrease in tumor
progression rate in patients receiving panitumumab versus those
receiving best supportive care, as assessed by central radiology
review). A secondary endpoint of objective response rate, as
assessed by central radiology review, was also met. Analysis of
overall patient survival in this study will occur 12 months after
the last patient was randomized. "Amgen is dedicated to developing
safe and effective cancer therapies that significantly improve
cancer patients' outcomes," said Willard Dere, M.D., chief medical
officer and senior vice president of Global Development at Amgen.
"We are excited that panitumumab, our most advanced investigational
cancer therapeutic, improved progression-free survival and response
rate in metastatic colorectal cancer patients who had failed
multiple prior chemotherapy regimens. These results will support a
BLA submission, which we plan to initiate by the end of the year."
"We are very encouraged by the results of this pivotal study and
what panitumumab could mean for patients with advanced colorectal
cancer," said Bill Ringo, president and chief executive officer of
Abgenix. "The improvement in progression-free survival shown by
panitumumab in this study highlights the value of our proprietary
technology and product development capabilities. We continue to
work closely with our partner, Amgen, towards the regulatory filing
and potential commercialization of panitumumab." Per protocol,
administration of panitumumab did not require administration of
pre-medication or a loading dose, and the incidence of infusion
reactions (of any severity) was low. An initial safety evaluation
showed that the adverse events observed were consistent with
previous clinical studies of panitumumab. The most common side
effect was acneiform rash. Other side effects less commonly
observed were fatigue, nausea and mild diarrhea. No human
anti-human antibody (HAHA) or anti-panitumumab antibody formation
was observed. Complete analyses of data from this trial will be
submitted for presentation at a medical meeting in 2006.
Panitumumab received Fast Track designation from the U.S. Food and
Drug Administration (FDA) in July 2005. Amgen and Abgenix are
working toward initiating the submission of the Biologics License
Application (BLA) to the FDA for panitumumab in patients who have
failed prior standard chemotherapy, including oxaliplatin and
irinotecan, by the end of 2005. FDA has previously indicated that
data from one pivotal trial, once completed, could be acceptable
with additional data from other ongoing studies to support a
submission for marketing approval in the United States. The
completed submission of the BLA is expected in the first quarter of
2006. Currently, panitumumab is being investigated as a single
agent or in combination with other agents across multiple lines of
treatment for various cancers. Patients and physicians can access
www.amgentrials.com for more information about ongoing panitumumab
clinical trials. About the Phase 3 Study The international,
multi-center, open-label, controlled Phase 3 study was conducted in
Europe, Australia and Canada, and enrolled 463 patients with
metastatic colorectal cancer who had failed standard chemotherapy,
including oxaliplatin and irinotecan. Patients were randomized to
receive panitumumab plus best supportive care (n=231) or best
supportive care alone (n=232). Those eligible received panitumumab
by intravenous infusion at a dose of 6 mg/kg once every two weeks.
There was no requirement that patients receive any pre-medication
prior to panitumumab administration. Best supportive care was
defined as the best palliative care available, as judged
appropriate by the investigator, and could include antibiotics,
analgesics, radiation therapy for pain control (limited to bone
metastases), corticosteroids, transfusions, psychotherapy, growth
factors, palliative surgery, or any other symptomatic therapy as
clinically indicated. For the purposes of this study, best
supportive care did not include anti-cancer chemotherapy.
Conference Call Information Amgen and Abgenix will host a
conference call with the investment community today at 8:00 a.m.
Pacific Time. Participating in the call will be Roger M.
Perlmutter, M.D., Ph.D., executive vice president of Research and
Development at Amgen, and Bill Ringo, president and chief executive
officer at Abgenix. 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. To
participate in the conference call, please dial 877-817-2450 or
706-634-7548 fifteen minutes before start time. The pass code for
the live call is 2201994. A telephonic replay of the call will be
available by dialing 800-642-1687 or 706-645-9291. The replay
participant code is 2201994. The webcast of the conference can be
found on Amgen's Web site, www.amgen.com, under Investors, and on
Abgenix's Web site, www.abgenix.com. The webcast will be archived
and available for replay at least 72 hours after the event. About
Panitumumab Co-developed by Amgen and Abgenix, panitumumab is the
first 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 Abgenix's XenoMouse(R)(1) 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 antibodies as foreign and launches an immune
response in the form of infusion reactions, allergic reactions or
anaphylaxis. The goal of developing fully human monoclonal
antibodies, which by definition contain no mouse protein, is to
offer effective, high affinity therapies that minimize the
potential for this type of immune response. 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 kidney. 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 104,950 new cases of colon cancer (48,290 men and 56,660
women) and 40,340 new cases of rectal cancer (25,530 men and 16,810
women) will be diagnosed in 2005. About Amgen 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. About Abgenix Abgenix is a
biopharmaceutical company focused on the discovery, development and
manufacturing of fully human therapeutic antibodies. The company's
antibody development platform includes a leading technology and
state-of-the-art manufacturing capabilities that enable the rapid
generation, selection and production of high affinity, fully human
antibody product candidates to a variety of disease targets.
Abgenix leverages its leadership position in human antibody
technology to build a diversified product portfolio through its own
development efforts and the establishment of collaborations with
multiple pharmaceutical and biotechnology companies. For more
information on Abgenix, visit the company's website at
www.abgenix.com. Amgen Forward-Looking Statement 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,
2004, 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
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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
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reimbursement and the reimbursement policies imposed by third-party
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trends toward managed care and healthcare cost containment as well
as possible U.S. legislation affecting pharmaceutical pricing and
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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. Abgenix Forward-Looking Statement Statements
made in this press release about Abgenix's technologies, product
development activities and collaborative arrangements, other than
statements of historical fact, are forward-looking statements and
are subject to a number of uncertainties that could cause actual
results to differ materially from the statements made, including
risks associated with the timing and success of clinical trials,
the progress of research and product development programs, product
manufacturing, timing and outcomes of regulatory approval
processes, competitive products and services, and the extent and
breadth of Abgenix's patent portfolio. Please see Abgenix's public
filings with the Securities and Exchange Commission for information
about risks that may affect Abgenix, including its Form 10-K for
the year ended December 31, 2004, and periodic reports on Form 10-Q
and Form 8-K. (1) XenoMouse(R) is a registered trademark of
Xenotech, a wholly-owned subsidiary of Abgenix, Inc. EDITOR'S NOTE:
An electronic version of this news release may be accessed via our
Web site at www.amgen.com. Journalists and media representatives
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