Immunex to Proceed With Supplemental FDA Filing
SEATTLE, March 22 /PRNewswire/ -- Preliminary analysis of data from a
Phase 3 clinical study, announced today by Immunex Corporation (Nasdaq: IMNX)
and Wyeth-Ayerst Laboratories, a division of American Home Products
Corporation (NYSE: AHP), demonstrated that psoriatic arthritis patients
receiving ENBREL(R) (etanercept) experienced significant improvement in signs
and symptoms of their disease compared to placebo.
Based on these results, the company plans to file a supplemental
biological license application (sBLA) with the U.S. Food and Drug
Administration (FDA) in mid-2001.
"We are extremely encouraged by these results," said Immunex senior vice
president, clinical development, Leslie Garrison, MD, MPH. "We will work
closely with the FDA to get this application rapidly approved since there are
currently very few effective treatment options for this devastating disease."
The study achieved the primary endpoint by demonstrating that psoriatic
arthritis patients experienced a decrease in disease activity, as measured by
the American College of Rheumatology (ACR) 20 composite score. The ACR 20 is
a standard measurement of response utilized to assess improvement in
rheumatoid arthritis patients. The study also assessed a variety of other
arthritis and skin endpoints, which also demonstrated improvement.
Side effects in the study were consistent with those reported with ENBREL
to date.
Data from this study will be submitted for presentation at a forthcoming
scientific meeting.
"We are pleased to see that response to ENBREL in this study confirms what
we had seen in previous psoriatic arthritis and rheumatoid arthritis trials,"
said Dan Burge, MD, Immunex vice president of clinical development. "Based on
this data, Immunex plans to request a priority review from the FDA of a
supplemental filing for approval to market ENBREL in psoriatic arthritis."
The Phase 3 study was a randomized, double-blind, placebo controlled study
of 205 patients with psoriatic arthritis. In this multi-center study,
patients were given either ENBREL (25 mg) or placebo by injection under the
skin twice weekly for six months.
Patients were allowed to enroll in the study if, prior to entry, they had
three tender and three swollen joints. In addition, patients needed to have
at least one 2 cm x 2 cm psoriatic skin lesion. All patients had not been
well-controlled on non-steroidal anti-inflammatory drugs (NSAIDs), a standard
treatment for psoriatic arthritis.
ABOUT PSORIATIC ARTHRITIS
Psoriatic arthritis is a chronic inflammatory disease of the joints and
connective tissue. The disease causes pain and swelling in some joints and
scaly skin patches on some areas of the body. It is related to the skin
condition psoriasis. About 95% of people with psoriatic arthritis have
swelling in joints outside of the spine and more than 80% of people with
psoriatic arthritis have nail lesions. Psoriatic arthritis patients are
generally treated by dermatologists and rheumatologists. Because there are
few treatments specifically approved for psoriatic arthritis, doctors often
use therapies approved for rheumatoid arthritis, NSAIDs or disease modifying
anti-rheumatic drugs (DMARDs). However, no DMARDs are currently approved for
use in psoriatic arthritis. There are approximately 250,000 patients with
psoriatic arthritis in the United States.
ABOUT ENBREL
The FDA approved ENBREL for reducing signs and symptoms and inhibiting
structural damage in patients with moderately to severely active RA as part of
an sBLA. The FDA originally approved ENBREL on November 2, 1998 to reduce
signs and symptoms of moderately to severely active rheumatoid arthritis in
patients who have an inadequate response to one or more DMARDs. ENBREL is the
only TNF inhibitor that can be used with or without methotrexate.
ENBREL acts by binding tumor necrosis factor (TNF). TNF is one of the
dominant cytokines or proteins that play an important role in normal immune
function and the cascade of reactions that cause the inflammatory process of
RA. ENBREL competitively inhibits binding of TNF molecules to the TNF receptor
(TNFR) sites. The binding of ENBREL to TNF renders the bound TNF biologically
inactive, resulting in significant reduction in inflammatory activity.
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 rare 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 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%). Only the rate of ISR was higher than that of
methotrexate. In all 1,197 RA patients studied, malignancies were rare (1%).
Immunex Corporation and Wyeth-Ayerst Laboratories market ENBREL in North
America. Other AHP affiliates market ENBREL outside of North America. Immunex
manufactures ENBREL. Additional information about ENBREL, including full
prescribing information, can be found on the company-sponsored website at
(http://www.enbrel.com) or by calling toll-free 888-4ENBREL (888-436-2735).
Immunex Corporation is a leading biopharmaceutical company dedicated to
improving lives through immune system science innovations.
American Home Products Corporation's Wyeth Ayerst division is a major
research-oriented pharmaceutical company with leading products in the areas of
women's health care, cardiovascular disease therapies, central nervous system
drugs, anti-inflammatory agents, vaccines, oncology and hemophilia products
and generic pharmaceuticals.
American Home Products Corporation is one of the world's largest research-
based pharmaceutical and health care products companies. It is a leader in the
discovery, development, manufacturing, and marketing of prescription drugs and
over-the-counter medications. It also is a global leader in vaccines,
biotechnology and animal health care.
NOTE: This new release contains forward-looking statements that involve
risks and uncertainties, including risks associated with clinical development,
regulatory approvals, our reliance on third-party manufacturers, product
commercialization and other risks described from time to time in the SEC
reports filed by Immunex, including the most recently filed Form 10-K. An
electronic version of this news release -- as well as additional information
about Immunex of interest to investors, customers, future employees and
patients -- is available on the Immunex home page at http://www.immunex.com.
Immunex will host a conference call and live webcast at 2:30 pm PST today
to discuss Immunex information disclosed today. The live webcast can be
accessed by going to the Immunex website at:
http://www.immunex.com/investor_fs3.html. Following the webcast, an
archived version of the call will be available at the same address until March
29, 2001.
SOURCE Immunex Corporation
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Related links:
http://www.immunex.com
Company News On-Call:
http://www.prnewswire.com/comp/434644.html or fax,
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CONTACT:
media, Robin Shapiro of Immunex Corporation,
206-389-4040; or Doug Petkus of Wyeth-Ayerst Laboratories,
610-902-7336; or investors, Mark Leahy of Immunex Corporation,
206-389-4363
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