Amgen Announces Positive Results of Phase 3 Enbrel Study in Psoriasis
FOR IMMEDIATE RELEASE
THOUSAND OAKS, Calif., January 17, 2003 – Amgen (NASDAQ: AMGN)today
announced that a phase 3 clinical study assessing the efficacy and tolerability of
ENBRELâ (etanercept) in the treatment of moderate to severe plaque psoriasis had
positive results, achieving the primary a nd all key secondary endpoints. Psoriasis is an
inflammatory disease affecting nearly 7 million people in the United States.
“It is encouraging to see that nearly half of the patients in the study quickly and
significantly responded to ENBREL with at least a 75 percent improvement of their
Psoriasis Area and Severity Index (PASI) score after 12 weeks,” said Dr. Beth
Seidenberg, Amgen's senior vice president of development. "In addition, patients
continued to show improvement over the entire treatment period with nearly 60 percent
of patients treated with ENBREL achieving this endpoint after 24 weeks.”
ENBREL was generally well tolerated in the study and adverse events at 12 weeks
were similar to those occurring in patients receiving placebo.
“These results are gratifying and advance our understanding of ENBREL as a potential
future therapy for patients with this life-impacting disease,” said Dr. Alice Gottlieb,
professor of medicine at the University of Medicine and Dentistry of the Robert Wood
Johnson Medical School, and a primary investigator in the study. ”Dermatologists will
likely welcome seeing the complete results of this study when they are presented at a
scientific meeting later this spring.”
Psoriasis, a disease that can significantly impact a patient's quality of life, is
characterized by chronic inflammation of the skin. This inflammation drives the
formation of skin plaques that are painful and disfiguring. Tumor necrosis factor (TNF) is
found at high levels in psoriatic plaques, and plays a critical role in their formation and
ENBREL is not approved by the U.S. Food and Drug Administration for the treatment of
psoriasis but clinical development continues with a second Phase 3 study that is
ENBREL is the only fully human anti-TNF receptor 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. It 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 disease-modifying medicines.
Physicians have become familiar with the benefits and proven long-term tolerability
profile of ENBREL. It has been used to treat over 130,000 patients worldwide since
becoming commercially available four years ago, making it one of the fastest-growing
prescription products ever launched.
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 causes the inflammatory process. The binding of ENBREL to TNF
renders the bound TNF biologically inactive, resulting in significant reduction in
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 infection (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
This news release contains forward-looking statements that involve significant risks and
uncertainties, including those discussed below and more fully described in the
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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 January 17, 2003, and expressly disclaims any duty to update
information contained in this press release.
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Rebecca Hamm (media)
Cary Rosansky (investors)
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