THOUSAND OAKS, Calif. and COLLEGEVILLE, Pa., Aug. 4
/PRNewswire-FirstCall/ -- Amgen (NASDAQ:AMGN) and Wyeth
Pharmaceuticals, a division of Wyeth (NYSE: WYE), issued a
statement in response to the Food and Drug Administration (FDA)
announcement regarding the results of a safety review of Tumor
Necrosis Factor (TNF) blockers [marketed as Remicade (infliximab),
Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab
pegol) and Simponi (golimumab)]. This safety review was the subject
of an FDA Early Communication in June 2008 pertaining to cases of
malignancy in pediatric patients exposed to a TNF blocker. As a
result of this review, the FDA has required strengthened warnings
about the occurrence of lymphoma and other cancers in children and
young adults using these medicines. AMGEN AND WYETH STATEMENT:
Amgen and Wyeth believe that ENBREL continues to offer a favorable
benefit-risk relationship for patients with the diseases for which
it is indicated to treat, including moderate to severe Juvenile
Idiopathic Arthritis (JIA). JIA can be a serious and potentially
debilitating condition. Amgen will work with the FDA to update the
U.S. Prescribing Information, and Medication Guide for ENBREL as
described in the FDA communication which can be read at
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm175803.htm.
In addition, Amgen and Wyeth will communicate the revised product
labeling to both physicians and patients. ENBREL was first approved
for JIA in the U.S. in 1999. It is estimated through postmarketing
data that approximately 13,847 pediatric patients have been treated
with ENBREL globally through February 2009, accounting for
approximately 44,600 patient-years of exposure. Postmarketing cases
of malignancies have been reported in pediatric patients treated
with ENBREL. Amgen and Wyeth are committed to patient safety and
support the continued evaluation of the potential risks and
benefits of TNF blockers for patients who are prescribed these
therapies. Both companies maintain ongoing safety surveillance
programs worldwide to review all data sources available to them,
and work with regulatory agencies to update the label as
appropriate based on emerging information. As always, physicians
and patients or their caregivers should carefully evaluate the
benefits and risks of ENBREL. ABOUT JUVENILE IDIOPATHIC ARTHRITIS
ENBREL was first approved for juvenile idiopathic arthritis (JIA),
formerly called juvenile rheumatoid arthritis, in 1999, and this is
the only FDA-approved use for ENBREL in the pediatric population.
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 has been studied in
JIA for up to nine years in controlled and open-label portions of a
clinical study. JIA is a systemic inflammatory disease that strikes
children before age 16 and can cause painful joint swelling,
deformity and stunted growth. According to the Arthritis
Foundation, JIA can impair a child's ability to take part in
physical activities, make daily activities such as schoolwork more
difficult, and affect a child's physical appearance. Parents and
siblings may be impacted by the psychological and financial stress
of chronic illness in a family member. ABOUT ENBREL ENBREL is a
soluble form of a fully human tumor necrosis factor (TNF) receptor.
ENBREL was first approved in 1998 for adult moderate to severe
rheumatoid arthritis and has more than 17 years of collective
clinical experience. 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 is the most important information
I should know about ENBREL? ENBREL is a medicine that affects your
immune system. ENBREL can lower the ability of your immune system
to fight infections. Serious infections have happened in patients
taking ENBREL. These infections include tuberculosis (TB) and
infections caused by viruses, fungi, or bacteria that have spread
throughout the body. Some patients have died from these infections.
Your doctor should test you for TB before you take ENBREL and
monitor you closely for TB while on ENBREL. Before starting ENBREL,
tell your doctor if you: -- Think you have, are being treated for,
have signs of, or are prone to infection. You should not start
taking ENBREL if you have any kind of infection. -- Have any open
cuts or sores -- Have diabetes or an immune system problem -- Have
TB or have been in close contact with someone who has had TB --
Were born in, lived in, or traveled to countries where there is
more risk for getting TB. Ask your doctor if you are not sure. --
Live or have lived in certain parts of the country (such as, the
Ohio and Mississippi River valleys, or the Southwest) where there
is a greater risk for certain kinds of fungal infections, such as
histoplasmosis. These infections may develop or become more severe
if you take ENBREL. If you don't know if histoplasmosis or other
fungal infections are common in the areas where you live or have
lived, ask your doctor. -- Have or have had hepatitis B -- Have
heart failure -- Develop symptoms such as persistent fever,
bruising, bleeding, or paleness while taking ENBREL -- Use the
medicine Kineret (anakinra) -- Have or develop a serious nervous
disorder, seizures, any numbness or tingling, or a disease that
affects your nervous system such as multiple sclerosis -- Are
scheduled to have surgery -- Are scheduled for any vaccines. All
vaccines should be brought up-to-date before starting ENBREL.
Patients taking ENBREL should not receive live vaccines. -- Are
allergic to rubber or latex -- Are pregnant, planning to become
pregnant, or breastfeeding After starting ENBREL, call your doctor
right away if you have any sign of infection, including a fever,
cough, flu-like symptoms, or have any open sores on your body.
ENBREL can make you more likely to get infections or make any
infection you have worse. Possible side effects of ENBREL Serious
side effects include: serious infections including TB; nervous
system problems, such as multiple sclerosis, seizures, or
inflammation of the nerves of the eyes; rare reports of serious
blood problems (some fatal); heart failure, including new heart
failure or worsening of heart failure you already have; allergic
reactions; immune reactions, including a lupus-like syndrome and
lymphoma (a type of cancer). People with rheumatoid arthritis and
psoriasis may have a higher chance for getting lymphoma. Common
side effects include: Injection site reaction, upper respiratory
infections (including sinus infection), and headaches. 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 http://www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see 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
http://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 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
http://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 Aug. 4, 2009, 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 based on current expectations of future
events and 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 the
inherent uncertainty of the timing and success of, and expense
associated with, research, development, regulatory approval and
commercialization of our products, including with respect to our
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; data generated on our 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." 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. CONTACT: Amgen, Thousand Oaks
Wyeth Sonia Fiorenza, 805-447-1604 Danielle Halstrom, 484-865-2020
(media) (media) John Shutter, 805-447-1060 Justin Victoria,
973-660-5340 (investors) (investors) (Logo:
http://www.newscom.com/cgi-bin/prnh/20081023/ENBRELLOGO)
http://www.newscom.com/cgi-bin/prnh/20081023/ENBRELLOGO
http://photoarchive.ap.org/ DATASOURCE: Amgen CONTACT: Media, Sonia
Fiorenza, +1-805-447-1604, or Investors, John Shutter,
+1-805-447-1060, both of of Amgen, Thousand Oaks; or Media,
Danielle Halstrom, +1-484-865-2020, or Investors, Justin Victoria,
+1-973-660-5340, both of Wyeth Web Site: http://www.amgen.com/
http://www.wyeth.com/
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm175803.htm
http://www.fda.gov/medwatch
Copyright