THOUSAND OAKS, Calif. & COLLEGEVILLE, Pa., Sep 04, 2008 (BUSINESS WIRE) -- Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth
(NYSE: WYE), issued a statement in response to the Food and Drug
Administration (FDA) safety announcement regarding opportunistic fungal
infections in patients treated with Tumor Necrosis Factor (TNF) blockers [marketed
as Remicade(R)
(infliximab), Enbrel(R)
(etanercept), Humira(R)
(adalimumab) and Cimzia(R)
(certolizumab pegol)].

AMGEN AND WYETH STATEMENT:

The FDA has reviewed reports of histoplasmosis and other opportunistic
fungal infections in patients treated with TNF-blockers. Although the
increased risk for infections is currently included in the U.S.
Prescribing Information for ENBREL, the FDA stated that specific
language around histoplasmosis and other opportunistic fungal infections
is necessary to help ensure the early diagnosis and treatment of these
uncommon and often undiagnosed conditions in patients on TNF-blocking
therapy.

Using its new authority under the Food and Drug Administration
Amendments Act of 2007 (FDAAA),the FDA has requested that the WARNINGS
and PRECAUTIONS section of the U.S. Prescribing Information and
Medication Guide for ENBREL be strengthened to include the risk of
developing opportunistic fungal infections, which will be consistent
with labeling changes requested for other medicines in the TNF-blocker
class. Amgen will work with the Agency to finalize and communicate
revised product labeling for ENBREL to both physicians and patients.

The FDA stated that patients taking TNF-blockers who develop a fungal
infection may be advised by their health care professional to stop the
TNF-blocker until they recover from the infection. The FDA has concluded
that histoplasmosis and other invasive fungal infections in individuals
taking TNF blockers are not consistently recognized and may go
untreated, potentially leading to deaths that may have been prevented
had appropriate treatment been administered. According to the FDA safety
announcement, this action "will help health
care professionals be more vigilant in watching for these adverse
events, and is necessary to ensure that the benefits of these drugs
outweigh the risks."

The full FDA safety announcement is available at http://www.fda.gov/cder/drug/InfoSheets/HCP/TNF_blockersHCP.htm.

Amgen and Wyeth are committed to the safety of patients. Both companies
maintain ongoing safety surveillance programs worldwide to analyze and
evaluate safety reports from controlled and open-label clinical trials
and patient registries, as well as reports received from health care
professionals and patients. Both companies work with regulatory agencies
to update the label periodically as appropriate based on emerging
information.

ABOUT HISTOPLASMOSIS

Histoplasmosis is a non-contagious infectious disease caused by a
fungus, most often affecting the lungs. Its symptoms vary greatly and
include a general ill feeling, a dry or nonproductive cough, chest
pains, fever, chills, headache, muscle aches, and loss of appetite. The
vast majority of those infected have no symptoms, or experience mild
flu-like symptoms that do not require medical attention. Disseminated
histoplasmosis can affect multiple organs, and can be fatal if
untreated. Histoplasmosis is seen more frequently in the central and
eastern portions of the U.S., particularly in areas bordering the Ohio
River Valley, as well as the areas surrounding the lower Mississippi
River.

ABOUT ENBREL

ENBREL is a soluble form of a fully human tumor necrosis factor (TNF)
receptor and has 16 years of collective clinical experience with an
established safety profile. ENBREL was first approved in 1998 for
moderate to severe rheumatoid arthritis and was later approved to treat
children and adolescents with juvenile rheumatoid arthritis (now called
juvenile idiopathic arthritis) in 1999. ENBREL was approved in 2004 to
treat moderate to severe plaque psoriasis in adults.

ENBREL indications in the U.S.:

--
ENBREL is indicated for reducing signs and symptoms, keeping joint
damage from getting worse, and improving physical function in patients
with moderate to severe rheumatoid arthritis. ENBREL can be taken with
methotrexate or used alone.

--
ENBREL is indicated for reducing the signs and symptoms of moderately
to severely active polyarticular juvenile idiopathic arthritis in
patients ages 2 and older.

--
ENBREL is indicated for reducing signs and symptoms, keeping joint
damage from getting worse, and improving physical function in patients
with psoriatic arthritis. ENBREL can be used in combination with
methotrexate in patients who do not respond adequately to methotrexate
alone.

--
ENBREL is indicated for reducing signs and symptoms in patients with
active ankylosing spondylitis.

--
ENBREL is indicated for the treatment of adult patients (18 years or
older) with chronic moderate to severe plaque psoriasis who are
candidates for systemic therapy or phototherapy.

Important Safety Information

What important safety information do I need to know about taking
prescription ENBREL?

ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker
that blocks the action of a substance your body's immune system makes
called TNF. People with an immune disease, such as rheumatoid arthritis,
juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic
arthritis, or psoriasis, have too much TNF in their bodies. ENBREL can
reduce the amount of active TNF in the body to normal levels, helping to
treat your disease. But, in doing so, ENBREL can also lower the ability
of your immune system to fight infections.

Serious infections, including tuberculosis (TB), have happened in
patients taking ENBREL. Some of these serious infections have been
fatal. Many serious infections occurred in people prone to infection.
Serious infections have also occurred in patients with advanced or
poorly controlled diabetes. Do not start ENBREL if you have an infection
or are allergic to ENBREL or its components. Once on ENBREL, if you get
an infection or have any sign of an infection, including fever, cough,
or flu-like symptoms, or have open sores, tell your doctor. Your doctor
should test you for TB before starting ENBREL and should monitor you
closely for signs and symptoms of TB.

Serious nervous system disorders, such as multiple sclerosis, seizures,
or inflammation of the nerves of the eyes have been reported. There have
been rare reports of serious blood disorders (some fatal).

In medical studies, more cases of lymphoma (a type of cancer) were seen
in patients taking TNF blockers compared to similar patients who were
not taking TNF blockers. The risk of lymphoma may be several-fold higher
in people with rheumatoid arthritis and psoriasis; the role of TNF
blockers in the development of malignancies is unknown.

Tell your doctor if you:

--
Think you have, are being treated for, have signs of, or are prone to
infection

--
Have any open sores

--
Have or have had TB or hepatitis B

--
Have ever been treated for heart failure

--
Have ever had or develop a serious nervous system disorder

--
Develop symptoms such as persistent fever, bruising, bleeding, or
paleness while taking ENBREL

Common side effects in adult clinical trials were injection site
reaction, infection and headache.

In a medical study of patients with JIA, infection, headache, abdominal
pain, vomiting, and nausea occurred more frequently than in adults. The
kinds of infections reported were generally mild and similar to those
usually seen in children. Other serious adverse reactions were reported,
including serious infection and depression/personality disorder.

If you have any questions about this information, be sure to discuss
them with your doctor. You are encouraged to report negative side
effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.

Please visit www.enbrel.com or call
1-888-4ENBREL to request additional information, including the U.S.
Prescribing Information and Medication Guide.

About Amgen and Wyeth

Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in
North America. Wyeth markets ENBREL outside of North America. Immunex
Corporation, a wholly owned subsidiary of Amgen, manufactures ENBREL.

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.

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
areas of women's health care, infectious
disease, gastrointestinal health, central nervous system, inflammation,
transplantation, hemophilia, oncology, vaccines and nutritional products.

Wyeth is one of the world's largest
research-driven pharmaceutical and health care products companies. It is
a leader in the discovery, development, manufacturing and marketing of
pharmaceuticals, vaccines, biotechnology products, nutritionals and
non-prescription medicines that improve the quality of life for people
worldwide. The Company's major divisions
include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge
Animal Health. To learn more, visit www.wyeth.com.

Amgen Forward-Looking Statement

This news release contains forward-looking statements that are based on
Amgen'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 Amgen's business.
Unless otherwise noted, Amgen is providing this information as of Sept.
4, 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 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 safety, side effects
or manufacturing problems with Amgen's
products after they are on the market. Amgen's
business may be impacted by government investigations, litigation and
products liability claims. Amgen depends on third parties for a
significant portion of its manufacturing capacity for the supply of
certain of its current and future products and limits on supply may
constrain sales of certain of its current products and product candidate
development.

In addition, sales of Amgen's 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 health care 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 Amgen's products. In addition,
Amgen competes with other companies with respect to some of its marketed
products as well as for the discovery and development of new products.
Amgen believes that some of its newer products, product candidates or
new indications for existing products, may face competition when and as
they are approved and marketed. Amgen's
products may compete against products that have lower prices,
established reimbursement, superior performance, are easier to
administer, or that are otherwise competitive with its products. In
addition, while Amgen routinely obtain patents for its products and
technology, the protection offered by its patents and patent
applications may be challenged, invalidated or circumvented by its
competitors and there can be no guarantee of Amgen's
ability to obtain or maintain patent protection for its products or
product candidates. Amgen cannot guarantee that it will be able to
produce commercially successful products or maintain the commercial
success of its existing products. Amgen's
stock price may be affected by actual or perceived market opportunity,
competitive position, and success or failure of its 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
Amgen's 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 Amgen's 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.

Wyeth Forward-Looking Statement

The statements in this press release that are not historical facts are
forward-looking statements that are subject to risks and uncertainties
that could cause actual results to differ materially from those
expressed or implied by such statements. These risks and uncertainties
include, without limitation, the inherent uncertainty of the timing and
success of, and expense associated with, research, development,
regulatory approval and commercialization of our products and pipeline
products; government cost-containment initiatives; restrictions on
third-party payments for our products; substantial competition in our
industry, including from branded and generic products; emerging data on
our products and pipeline products; the importance of strong performance
from our principal products and our anticipated new product
introductions; the highly regulated nature of our business; product
liability, intellectual property and other litigation risks and
environmental liabilities; uncertainty regarding our intellectual
property rights and those of others; difficulties associated with, and
regulatory compliance with respect to, manufacturing of our products;
risks associated with our strategic relationships; economic conditions
including interest and currency exchange rate fluctuations; changes in
generally accepted accounting principles; trade buying patterns; the
impact of legislation and regulatory compliance; risks and uncertainties
associated with global operations and sales; and other risks and
uncertainties, including those detailed from time to time in our
periodic reports filed with the Securities and Exchange Commission,
including our current reports on Form 8-K, quarterly reports on Form
10-Q and annual report on Form 10-K, particularly the discussion under
the caption "Item 1A, Risk Factors"
in our Annual Report on Form 10-K for the year ended December 31, 2007,
which was filed with the Securities and Exchange Commission on February
29, 2008. The forward-looking statements in this press release are
qualified by these risk factors. We assume no obligation to publicly
update any forward-looking statements, whether as a result of new
information, future developments or otherwise.

SOURCE: Amgen

Amgen, Thousand Oaks 
Sonia Fiorenza, 805-447-1604 (media) 
Arvind Sood, 805-447-1060 (investors) 
or 
Wyeth 
Danielle Halstrom, 484-865-2020 (media) 
Justin Victoria, 973-660-5340 (investors)

Copyright Business Wire 2008