THOUSAND OAKS, Calif., & COLLEGEVILLE, Pa.--(BUSINESS WIRE)--Sept.
28, 2004--Amgen Inc. (NASDAQ:AMGN) and Wyeth Pharmaceuticals, a
division of Wyeth (NYSE:WYE), today announced that the new 50 mg/mL
prefilled syringe of Enbrel(R) (etanercept) has been approved by the
U.S. Food and Drug Administration (FDA) as the recommended dosing form
for treatment in all approved adult indications. The new prefilled
syringe, available for patient use in the fourth quarter 2004, will
eliminate the need to mix drug prior to injecting and allows most
patients receiving ENBREL to take only one injection per week, instead
of the two 25 mg injections currently used weekly by patients.
"Since the rheumatoid arthritis approval in 1998, ENBREL has
helped thousands of people better manage their disease," said Beth
Seidenberg, M.D., chief medical officer and senior vice president of
global development, Amgen. "This approval provides physicians with the
opportunity to offer their patients an easy-to-use prefilled syringe
that delivers the same drug patients and physicians have grown to
The FDA approval was based on a study, which found that the ENBREL
50 mg/mL prefilled syringe was shown to be biologically equivalent to
two 25 mg vials. The 25 mg formulation will still be available for
juvenile rheumatoid arthritis patients and those that prefer that
"This new delivery system can make it easier for patients to
receive the proven efficacy and established tolerability of ENBREL,"
said Joseph Camardo, M.D., senior vice president, global medical
affairs, Wyeth Pharmaceuticals. "It may be especially beneficial to
people who have rheumatoid arthritis or active psoriatic arthritis, as
their hands may be affected by the disabling joint destruction these
conditions can cause."
ENBREL is a leading biologic treatment for moderately to severely
active rheumatoid arthritis and is the first and only TNF inhibitor
approved to treat chronic moderate to severe plaque psoriasis, active
psoriatic arthritis, active ankylosing spondylitis (arthritis of the
spine) and children with moderately to severely polyarticular-course
active juvenile rheumatoid arthritis in patients who have had an
inadequate response to one or more disease-modifying antirheumatic
ENBREL is the only fully human TNF receptor approved to reduce
signs and symptoms, induce major clinical response, improve physical
function, and inhibit the progression of structural damage in patients
with moderately to severely active rheumatoid arthritis (RA). ENBREL
is also indicated to reduce the signs and symptoms and inhibit the
progression of structural damage of active arthritis in patients with
psoriatic arthritis. ENBREL is the only biologic therapy approved for
first-line treatment of RA patients, and can be used alone or in
combination with methotrexate.
ENBREL is also approved to reduce the signs and symptoms of
moderately to severely active polyarticular-course juvenile rheumatoid
arthritis (JRA) in patients who have had an inadequate response to one
or more disease-modifying antirheumatic drugs (DMARDs). It is also the
first biologic approved to treat the signs and symptoms in patients
with active ankylosing spondylitis (AS). 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
ENBREL has been used by more than 250,000 patients worldwide
ENBREL acts by binding TNF, one of the dominant inflammatory
cytokines or regulatory proteins that play an important role in both
normal immune function and the cascade of reactions that are involved
in the inflammatory process of RA, JRA, psoriasis, psoriatic arthritis
and AS. The binding of ENBREL to TNF renders the bound TNF
biologically inactive, resulting in significant reduction in
Since the product was first introduced, the following have been
reported in patients using ENBREL:
Many occurred in people prone to infection, such as those
with advanced or poorly controlled diabetes
Some serious infections were fatal
Rare cases of tuberculosis
What to do/Not to do
Do not start ENBREL if you have an infection or are
allergic to ENBREL or its components.
Tell your doctor if you are prone to infection.
Stop ENBREL if a serious infection occurs.
Contact your doctor if you have questions about ENBREL or
develop an infection.
Tell your doctor if you have ever been treated for heart
Serious nervous system disorders such as multiple sclerosis,
seizures, or inflammation of the nerves of the eyes
Tell your doctor if you have ever had any of these
disorders or if you develop them after starting ENBREL.
Rare reports of serious blood disorders (some fatal)
Contact your doctor immediately if you develop symptoms
such as persistent fever, bruising, bleeding, or paleness.
In medical studies of all TNF-inhibitors, a higher rate of
lymphoma (a type of cancer) was seen compared to the general
population, however, the risk of lymphoma may be up to several
fold higher in RA and psoriasis patients.
The role of TNF-inhibitors in the development of lymphoma
The incidence of other cancers has not increased with extended
exposure to ENBREL and is similar to the expected rate.
ENBREL can also cause injection site reactions.
In a medical study of patients with JRA, infections,
headaches, 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 rarely,
including serious infections (2 percent) and
depression/personality disorder (1 percent).
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. Additional information about ENBREL, including
full Prescribing Information, can be found on the Web site sponsored
by the companies at www.enbrel.com or by calling toll free 888-4ENBREL
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on
advances in cellular and molecular biology. Wyeth Pharmaceuticals, a
division of Wyeth, has leading products in the areas of women´s health
care, cardiovascular disease, 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 nonprescription
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.
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, 2003, 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 we project. Amgen´s results may be
affected by its ability to successfully market both new and existing
products domestically and internationally, sales growth of recently
launched products, difficulties or delays in manufacturing its
products, and regulatory developments (domestic or foreign) involving
current and future products and manufacturing facilities. In addition,
sales of Amgen´s products are affected by 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 regulations and
reimbursement policies may affect the development, usage and pricing
of Amgen´s products. Furthermore, Amgen´s research, testing, pricing,
marketing and other operations are subject to extensive regulation by
domestic and foreign government regulatory authorities. Amgen or
others could identify side effects or manufacturing problems with its
products after they are on the market.
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. Discovery or identification of new
product candidates cannot be guaranteed and movement from concept to
product is uncertain; consequently, there can be no guarantee that any
particular product candidate will be successful and become a
In addition, while Amgen routinely obtains patents for its
products and technology, the protection offered by its patents and
patent applications may be challenged, invalidated or circumvented by
its competitors. Further, some raw materials, medical devices and
component parts for Amgen´s products are supplied by sole third party
The statements in this press release that are not historical facts
are forward-looking statements based on current expectations of future
events that involve risks and uncertainties including, without
limitation, risks associated with the inherent uncertainty of
pharmaceutical research, product development, manufacturing, and
commercialization, and economic conditions, including interest and
currency exchange rate fluctuations, the impact of competitive or
generic products, product liability and other types of lawsuits, the
impact of legislative and regulatory compliance and obtaining
approvals, and patents, and other risks and uncertainties, including
those detailed from time to time in Wyeth´s periodic reports,
including quarterly reports on Form 10-Q and the Annual Report on Form
10-K, filed with the Securities and Exchange Commission. Actual
results may vary materially from the forward-looking statements. Wyeth
assumes no obligation to publicly update any forward-looking
statements, whether as a result of new information, future events or
Nurha Hindi, 805-447-4587 (media)
Laura Biswas, 805-447-1060
Doug Petkus, 484-865-5140 (media)
Justin Victoria, 973-660-5340 (investors)
SOURCE: Amgen Inc.