New Patients Interested in Joining the Enrollment Program Are Encouraged
To Call 888-4-ENBREL
SEATTLE, April 11 /PRNewswire/ -- The maker of ENBREL(R) (etanercept)
announced today that approximately 2,500 new patients are being offered
"active" status in the ENBREL Enrollment Program. Patients are offered active
status when they have completed their application and supply is available.
"This is good news for thousands of patients who have been waiting to try
ENBREL," said Mark Booth, general manager for ENBREL at
Immunex Corporation (Nasdaq: IMNX).
The ENBREL Enrollment program was launched in November 2000 to identify
and enroll current users of the highly prescribed tumor necrosis factor (TNF)
inhibitor ENBREL because growing demand was projected to exceed the current
supply. Immunex and Wyeth-Ayerst Laboratories (a division of American Home
Products Corporation, (NYSE: AHP)), the companies that market ENBREL in the
United States, initiated the program so that patients already using ENBREL
could continue to receive therapy.
In an extraordinary response to the program, more than 77,000 patients
have joined the ENBREL Enrollment Program, with approximately 67,000 patients
having at least one ENBREL prescription filled since January. The companies
established a queue system for new patients, to manage demand and available
supply.
"Because we now better understand the ordering and utilization patterns of
current users in the program, we are very pleased that we can now make ENBREL
available to a number of new patients," said Booth. "We anticipate activating
more new patients who are waiting to use ENBREL as usage patterns and
available supply allows."
New patients interested in using ENBREL can call 888-4ENBREL to enroll in
the program and will join the patient queue.
As the companies have previously announced, supplies of ENBREL will be
limited until mid-2002, when a manufacturing facility expansion is expected to
be completed. The new facility in Rhode Island is one part of a strategic
program to increase manufacturing supply of ENBREL. The program also includes
development of another manufacturing facility in Ireland, which is expected to
produce ENBREL for the commercial market by 2005.
ABOUT ENBREL
ENBREL is currently approved for reducing signs and symptoms and
inhibiting the progression of structural damage in patients with moderately to
severely active RA. 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 both with methotrexate or
alone.
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: Except for the historical information contained herein, this news
release contains forward-looking statements that involve substantial risks and
uncertainties. Among the factors that could cause actual results or timelines
to differ materially are risks associated with research and clinical
development, regulatory approvals, our supply capabilities and reliance on
third-party manufacturers, product commercialization, competition, litigation
and other risk factors listed from time to time in reports filed by Immunex
with the SEC, including but not limited to risks described under the caption
"Important Factors That May Affect Our Business, Our Results of Operations and
Our Stock Price" within our most recently filed Form 10-K. The
forward-looking statements contained in this news release represent our
judgment as of the date of this release. Immunex undertakes no obligation to
publicly update any forward-looking statements. 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.
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,
800-758-5804, ext. 434644
CONTACT:
media, Doug Petkus of Wyeth-Ayerst,
610-902-7336; or Robin Shapiro, 206-3894-4040, or investors, Mark
Leahy, 206-389-4363, both of Immunex
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