Immunex Takes Additional Steps to Expand Supply To Help Keep Up With Growing
Demand for Sales of ENBREL
SEATTLE, April 15 /PRNewswire-FirstCall/ --
Immunex Corporation (Nasdaq: IMNX) today announced a manufacturing agreement
with Genentech, Inc. to produce ENBREL(R) (etanercept) at Genentech's
manufacturing facility in South San Francisco. Subject to the approval of the
U.S. Food and Drug Administration, the facility is expected to add supply
capacity for ENBREL, beginning in 2004. Currently, ENBREL is manufactured at
a plant operated by Immunex's manufacturing partner, and at Immunex's Rhode
Island facility, expected to be approved later this year.
"We're working hard to help assure that the growing demand for ENBREL is
met," said Peggy Phillips, Immunex's executive vice president and chief
operating officer.
ENBREL was launched in 1998 and is now marketed for reducing signs and
symptoms and inhibiting the progression of structural damage in patients with
moderately to severely active rheumatoid arthritis (RA). ENBREL is also the
first and only therapy approved to reduce the signs and symptoms of active
arthritis in patients with psoriatic arthritis. Additionally, Immunex is
studying ENBREL in a Phase 2/3 clinical study for psoriasis, and Phase 3
clinical studies for ankylosing spondylitis and Wegener's granulomatosis.
"This Genentech agreement adds flexibility and depth to our plans to
expand the production capacity of ENBREL to the multi-billion dollar level,"
said Phillips.
The agreement will be for a fixed time frame. Upon approval of the FDA,
which the parties hope to obtain in early 2004, the Genentech facility will
become a licensed manufacturing site for commercial supply of ENBREL. Under
the terms of the agreement, Genentech will produce ENBREL through 2005, and
the parties can by mutual agreement extend production through 2006.
The collaboration with Genentech represents another in a series of
strategic steps Immunex is taking to increase both short-term and long-term
supply of ENBREL. In November 2001, Immunex broke ground on the BioNext
Project(TM), second manufacturing plant in West Greenwich, Rhode Island, which
will be dedicated to the production of ENBREL and other products. Once
completed, it will be one of the largest and most advanced cell culture
manufacturing centers in the world.
ABOUT ENBREL
ENBREL is the only TNF receptor on the market. It 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 cause the inflammatory process of RA and psoriatic arthritis. 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 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(R) (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. In all 1,197 RA patients studied, malignancies were rare
(1%).
Adverse events in the psoriatic arthritis trial were similar to those
reported in RA clinical trials.
Immunex Corporation and Wyeth Pharmaceuticals, a division of Wyeth
(NYSE: WYE), market ENBREL in North America. Other Wyeth 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 Web site 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.
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. Wyeth's major divisions include Wyeth Pharmaceuticals, Wyeth
Consumer Healthcare and Fort Dodge Animal Health.
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.
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SOURCE Immunex Corporation
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http://www.immunex.com
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CONTACT:
press, Robin Shapiro, +1-206-389-4040, or
investors, Mark Leahy, +1-206-389-4363, both of Immunex
Corporation
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