Enbrel Offered To Additional 40,000 Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis And Psoriatic Arthritis Patients
FOR IMMEDIATE RELEASE
THOUSAND OAKS, Calif., and RADNOR, Penn., December 2, 2002 – Amgen
(NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE),
today announced that supply of the breakthrough biologic, ENBRELâ (etanercept), has
been offered over the past 8 weeks to more than 40,000 patients on the ENBREL
Prospective Patient List. These patients and their physicians are being notified that
they may now order ENBREL.
“We are pleased to be able to deliver on the companies' commitment to release
ENBREL supply as it becomes available for these rheumatoid arthritis, juvenile
rheumatoid arthritis, and psoriatic arthritis patients,” said Kevin Young, vice president
and general manager of Amgen's Inflammation Business Unit. “We have experienced
improved efficiencies at the current ENBREL manufacturing facility that have helped
enable us to make this large-scale offering of supply to patients.”
“This step is significant in that it opens the door for more patients to benefit from
ENBREL, the only TNF receptor therapy distinguished by five years of data supporting
its consistent and sustained efficacy and long -term tolerability,” said Joseph Mahady,
president North America, Wyeth Pharmaceuticals.
The ENBREL Enrollment Program will remain in effect to help current patients continue
to have access to ENBREL. Patients can enroll by calling 1-888-4ENBREL
ENBREL is the only fully human, anti-TNF therapy approved for use to reduce the signs
and symptoms of active arthritis in patients with psoriatic arthritis, and to reduce the
signs and symptoms and inhibit the progression of structural damage in patients with
moderately to severely active rheumatoid arthritis (RA). ENBREL is the only biologic
therapy approved to treat newly diagnosed RA patients, and can be used alone.
ENBREL is also approved to reduce the signs and symptoms of moderately to severely
active polyarticular-course juvenile rheumatoid arthritis (JRA) in patients 4 years of age
and older who have had an inadequate response to one or more disease-modifying
antirheumatic drugs (DMARDs).
Rheumatologists have become familiar with the benefits and proven long -term
tolerability profile of ENBREL, having treated over 129,000 patients worldwide in over
four years of post-marketing experience. –
ENBRELâ (etanercept) 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 causes the inflammatory process of psoriatic
arthritis and RA. The binding of ENBREL to TNF renders the bound TNF biologically
inactive , resulting in significant reduction in inflammatory activity.
Important Treatment Considerations
SINCE THE PRODUCT WAS FIRST INTRODUCED, SERIOUS INFECTIONS, SOME
INVOLVING DEATH, HAVE BEEN REPORTED IN PATIENTS USING ENBREL.
MANY OF THESE INFECTIONS OCCURRED IN PATIENTS WHO WERE PRONE TO
INFECTIONS, SUCH AS THOSE WITH ADVANCED OR POORLY CONTROLLED
DIABETES. RARE CASES OF TUBERCULOSIS HAVE ALSO BEEN REPORTED.
ENBREL SHOULD BE DISCONTINUED IN PATIENTS WITH SERIOUS INFECTIONS.
DO NOT START ENBREL IF YOU HAVE AN INFECTION OF ANY TYPE OR IF YOU
HAVE AN ALLERGY TO ENBREL OR ITS COMPONENTS. ENBREL SHOULD BE
USED WITH CAUTION IN PATIENTS PRONE TO INFECTION. CONTACT YOUR
PHYSICIAN IF YOU HAVE ANY QUESTIONS ABOUT ENBREL OR INFECTIONS.
There have been reports of 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. There have also been rare reports of serious blood disorders, some involving
death. Contact your doctor immediately if you develop symptoms such as
persistent fever, bruising, bleeding, or paleness. It is unclear if ENBREL has
caused these nervous system or blood disorders. If your doctor confirms serious blood
problems, you may need to stop using ENBREL.
The most frequent adverse events in placebo-controlled RA clinical trials involving 349
adults were injection site reactions (ISR) (37%), infections (35%), and headache (17%).
Only the rate of ISR was higher than that of placebo. The most frequent adverse events
in a methotrexate-controlled clinical trial of 415 adults with early-stage RA were
infections (64%), ISR (34%), and headache (24%). Of these, only the rate of ISR was
higher than that of methotrexate. Patients have been observed in clinical trials for over
3 years. The incidence of malignancies has not increased with extended exposure to
ENBREL and is similar to the projected background rate.
Adverse events in the psoriatic arthritis trial were similar to those reported in RA clinical
In a study of 69 patients with JRA, infections (62%), headache (19%), abdominal pain
(19%), vomiting (13%), and nausea (9%) occurred more frequently than in adults. The
types of infections reported in JRA patients were generally mild and consistent with
those commonly seen in children. Serious adverse reactions reported rarely were
chicken pox (3%), gastroenteritis (3%), serious infections (2%), depression/personality
disorder (1%), skin ulcer (1%), inflammation in parts of the upper digestive tract (1%),
and diabetes (1%).
Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in North
America. Other Wyeth affiliates market 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-
Amgen is a global biotechnology company that discovers, develops, manufactures and
markets important human therapeutics based on advances in cellular and molecular
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of
women's health care, cardiovascular disease, central nervous system, inflammation,
hemophilia, oncology and vaccines. 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.
This news release contains forward-looking statements that involve significant risks and
uncertainties, including those discussed below and more fully described in the
Securities and Exchange Commission reports filed by Amgen, including Amgen's most
recent Form 10-Q. Amgen conducts research in the biotechnology/pharmaceutical field
where movement from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate will be successful and become a
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Because forward-looking statements involve risks and uncertainties, actual results may
differ materially from current results expected by Amgen. Amgen is providing this
information as of December 2, 2002, and expressly disclaims any duty to update
information contained in this press release.
CONTACT: Amgen Wyeth Pharmaceuticals
Rebecca Hamm (media) Douglas Petkus (media)
Cary Rosansky (investors) Justin Victoria (investors)
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