Abgenix and Amgen Announce FDA Grants Panitumumab Fast Track Designation for Metastatic Colorectal Cancer
THOUSAND OAKS, Calif. & FREMONT, Calif.--(BUSINESS WIRE)--Aug. 1,
2005--Amgen (Nasdaq:AMGN) and Abgenix, Inc. (Nasdaq:ABGX) today
announced that the U.S. Food and Drug Administration (FDA) has granted
fast track designation for panitumumab, an experimental fully human
monoclonal antibody directed against the epidermal growth factor
receptor (EGFr), for patients with metastatic colorectal cancer who
have failed standard chemotherapy treatment.
"We are advancing the development of panitumumab with the hope of
offering patients a new treatment option in their fight against
metastatic colorectal cancer," said Willard Dere, M.D., chief medical
officer and senior vice president of global development at Amgen.
Under the FDA Modernization Act of 1997, fast track designation
allows the FDA to accept, on a rolling basis, portions of a marketing
application for review prior to the completion of the final
registrational package. Fast track designation may potentially
expedite the review of a drug that is intended for the treatment of a
serious life-threatening condition and demonstrates the potential to
address an unmet medical need for such a condition.
In light of this fast track designation, Amgen and Abgenix are
working toward initiating the submission of the Biologics License
Application (BLA) for panitumumab in patients who have failed prior
standard chemotherapy, including irinotecan and oxaliplatin, by the
end of 2005. The completed submission of the BLA could extend into the
first quarter of 2006, depending on timing and outcome of clinical
data. FDA has previously indicated that data from one pivotal trial,
once completed, could be acceptable with additional data from other
pending studies to support a submission for marketing approval in the
United States.
"Panitumumab is the first fully human monoclonal antibody to
inhibit EGFr, and fast track designation represents an important
milestone in its development," said Bill Ringo, chief executive
officer at Abgenix. "We are one step closer to bringing this promising
new treatment to patients with advanced colorectal cancer."
Patients and physicians can access www.amgentrials.com for more
information about ongoing panitumumab clinical trials.
About Panitumumab
Co-developed by Amgen and Abgenix, panitumumab is an
investigational product in a novel class of targeted cancer treatments
called epidermal growth factor receptor (EGFr) inhibitors. Panitumumab
(formerly ABX-EGF) is the first fully human monoclonal antibody
directed against EGFr and is being evaluated as both a monotherapy and
in combination with other agents for the treatment of various types of
cancer, including colorectal, lung and kidney. Panitumumab was
generated with Abgenix's XenoMouse(R)(1) technology, which creates a
fully human monoclonal antibody that contains no murine (mouse)
protein. The fully human nature of panitumumab may result in a safety
profile with a low incidence of infusion reactions, antigenicity and
allergic response. These are attributes currently being investigated
in clinical trials. Pivotal clinical studies evaluating panitumumab as
a third-line monotherapy in colorectal cancer patients are ongoing
with an every-other-week dosing regimen.
About the Epidermal Growth Factor Receptor (EGFr)
Although EGFr normally helps regulate the growth of many different
cells in the body, EGFr can also 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, epidermal
growth factor (EGF) or transforming growth factor alpha (TGFa), 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 EGF and TGFa 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 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 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.
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(1) XenoMouse(R) is a registered trademark of Xenotech, a
wholly-owned subsidiary of Abgenix, Inc.
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SOURCE: Amgen