Amgen and Abgenix Complete Biologics License Application for FDA Approval of Panitumumab
30 März 2006 - 4:00PM
Business Wire
Amgen (Nasdaq: AMGN) and Abgenix, Inc. (Nasdaq: ABGX) today
announced that Amgen has completed the Biologic License Application
(BLA) submission with the U.S. Food and Drug Administration (FDA)
for panitumumab. The potential indication is for the treatment of
metastatic colorectal cancer in patients who have failed prior
chemotherapy, including oxaliplatin and/or irinotecan containing
regimens. The rolling BLA submission was initiated in December
2005. "The pivotal Phase 3 study of panitumumab not only met the
primary endpoint of improving progression-free survival in patients
with metastatic colorectal cancer, but the results surpassed our
expectations based on preset measurement criteria in the protocol,"
said Willard Dere, M.D., chief medical officer and senior vice
president of Global Development at Amgen. "Completing the BLA
brings us one step closer to realizing our goal of making
panitumumab accessible to patients with metastatic colorectal
cancer who have failed available treatment options." Amgen and
Abgenix previously announced that data from a randomized Phase 3
trial involving 463 patients showed that 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 0.000 000 001). The most common side effect was
acneiform rash. Other side effects less commonly observed were
fatigue, nausea and mild diarrhea. Results from this pivotal Phase
3 study will be presented in a Clinical Plenary Session at the 97th
Annual Meeting of the American Association for Cancer Research on
April 3, 2006. Amgen will host a webcast with the investment
community to discuss the results on Monday, April 3, 2006, at 12:30
P.M. EDT. Open to members of the news media, investors and the
general public, the webcast can be found on Amgen's Web site,
www.amgen.com, under Investors. It will be archived and available
for replay at least 72 hours after the event. About Panitumumab
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
launch an immune response in the form of infusion reactions,
allergic reactions or anaphylaxis. The goal of developing fully
human monoclonal antibodies is to offer effective, high affinity
therapies that minimize the potential for this type of immune
response. Panitumumab received Fast Track designation from the U.S.
Food and Drug Administration (FDA) in July 2005 for patients with
metastatic colorectal cancer who have failed standard chemotherapy
treatment. It 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. 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, 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 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 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
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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
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of Amgen's ability to obtain or maintain patent protection for
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it will be able to produce commercially successful products or
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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, collaborative arrangements and the proposed
merger with Amgen, 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. For example, statements regarding the
expected timing of the closing of the merger are forward-looking
statements. Factors that could cause actual results to differ
materially from those contemplated above include, among others, the
risks associated with the timing and success of clinical trials,
the progress of research and product development programs, product
manufacturing, consummating the merger with Amgen, timing and
outcomes of regulatory approval processes, competitive products and
services, litigation and the extent and breadth of Abgenix's patent
portfolio. Please see Abgenix's public filings with the Securities
and Exchange Commission (SEC) for information about risks that may
affect Abgenix, including its Form 10-K for the year ended December
31, 2005, and reports on Form 10-Q and Form 8-K. EDITOR'S NOTE: An
electronic version of this news release may be accessed via our Web
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