Amgen Announces Results Of Phase 3 Study Of Enbrel Dosed Once Weekly
FOR IMMEDIATE RELEASE
THOUSAND OAKS, Calif., December 5, 2002 – Amgen (NASDAQ: AMGN) today announced
that a clinical study assessing 50 mg of ENBRELâ (etanercept) administered once weekly
demonstrated similar efficacy, tolerability and pharmacokinetics to that of 25 mg of ENBREL
administered twice weekly.
“We are pleased with these results and look forward to presenting comprehensive results from this
study at a future scientific meeting,” said Dr. Daniel Burge, Amgen's vice president of clinical research.
“This study suggests that physicians may have the opportunity to combine the benefits and proven
long-term tolerability profile of ENBREL with the flexibility of either once weekly or twice weekly
dosing,” said Kevin Young, vice president and general manager of Amgen's Inflammation Business
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 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
Rheumatologists have become familiar with the benefits and proven long-term tolerability profile of
ENBREL, having treated over 129,000 patients in over four years of post-marketing experience.
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 of psoriatic arthritis and RA. The binding of ENBREL to TNF
renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory
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 ENBRELâ (etanercept). 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 trials.
Please see full Product Information.
Amgen and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), 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 888-4ENBREL (888-436-
Amgen is a global biotechnology company that discovers, develops, manufactures and markets
important human therapeutics based on advances in cellular and molecular biology.
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 our 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 commercial product.
Furthermore, our research, testing, pricing, marketing and other operations are subject to
extensive regulation by domestic and foreign government regulatory authorities. In addition, sales
of our products are affected by reimbursement policies imposed by third party payors, including
governments, private insurance plans and managed care providers. These government
regulations and reimbursement policies may affect the development, usage and pricing of our
In addition, while we routinely obtain patents for our products and technology, the protection
offered by our patents and patent applications may be challenged, invalidated or circumvented by
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 5, 2002, and expressly disclaims any duty to update information contained in this
Rebecca Hamm (media)
Cary Rosansky (investors)
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