NOVANTRONE(R) APPLICATION FOR MULTIPLE SCLEROSIS GRANTED
PRIORITY REVIEW BY
FDA FDA REVIEW OF NOVANTRONE DATA TO BE COMPLETED WITHIN
SIX Months
July 19, 1999
SEATTLE, Jul 19, 1999 /PRNewswire via COMTEX/ -- Immunex
Corporation
(Nasdaq: IMNX) announced today that the U.S. Food and
Drug Administration
(FDA) has assigned priority review status to the new
drug application (NDA)
for NOVANTRONE(R) (mitoxantrone for injection concentrate),
indicating that
the FDA will act on the application within six months
of its date of
submission. Immunex filed for expanded labeling for NOVANTRONE
for the
treatment of patients with secondary progressive multiple
sclerosis (MS) on
June 7, 1999.
"This is an important milestone in the development of
NOVANTRONE as a
potential treatment for people with secondary progressive
MS," said Peggy V.
Phillips, senior vice president, pharmaceutical development
for Immunex. "We
will continue to work closely with the FDA over the next
six months as they
evaluate these data."
The results of the pivotal NOVANTRONE Phase III study
showed that
NOVANTRONE had a statistically significant impact on
reduction of relapse
rate and delay in disability progression in patients
with secondary
progressive MS. Additional follow-up data presented at
a recent
international conference showed that one year after treatment
was stopped,
patients treated with NOVANTRONE continued to experience
a reduction in
their number of attacks, and a delay in their disability
progression.
In the study, treatment with NOVANTRONE resulted in generally
manageable side effects that were primarily mild to moderate.
During the
two-year trial, the most frequent side effects reported
by patients treated
in the 12 mg/m2 arm were nausea, alopecia (hair loss),
upper respiratory
tract infection, urinary tract infection, menstrual disorder,
and transient
neutropenia (a reduced number of white blood cells).
Multiple sclerosis is a chronic, debilitating disease
of the central
nervous system that, in its various stages, afflicts
as many as 350,000
people in the United States. The symptoms of MS result
when a breakdown
occurs inthe myelin sheath, the fatty substance that
insulates the nerve
fibers of the brain and spinal cord. This demyelination
process causes
patches of scar tissue, or "sclerosis," which interfere
with the nerve's
ability to transport messages from the brain to body
parts. This can result
in a variety of symptoms that range from numbness in
the limbs to complete
paralysis.
Approximately 120,000 MS patients in the U.S. have a form
of the
disease classified as secondary progressive. These patients
often are
initially diagnosed with relapsing-remitting disease,
in which their
symptoms flareup and then ease or even disappear for
months or years.
Eventually, the neurological function of patients who
develop secondary
progressive MS begins to steadily worsen as flares become
more frequent and
severe, and recovery is incomplete. There are currently
no approved
treatments in the United States for people with secondary
progressive MS.
NOVANTRONE is currently marketed to treat pain in patients
with
advanced hormone-refractory prostate cancer in combination
with
corticosteroids andfor initial therapy of acute nonlymphocytic
leukemia. It
is not approved foruse in MS patients. Full prescribing
information for
NOVANTRONE can be obtained by calling 800-IMMUNEX or
visiting
www.immunex.com.
Immunex Corporation is a biopharmaceutical company dedicated
to
developing immune system science to protect human health.
The company's
products offer hope to patients with cancer, inflammatory
and infectious
diseases.
American Home Products Corporation owns a majority interest
in
Immunex. AHPC is one of the world's largest research-based
pharmaceutical
and health care products companies and is a leading developer,
manufacturer
and marketer of prescription drugs and over-the-counter
medications. It is
also a leader in vaccines, biotechnology, agricultural
products and animal
health care.
NOTE: This news release contains forward-looking statements
that
involve risks and uncertainties, including risks associated
with clinical
development, regulatory approvals, product commercialization
and other risks
described from time to time in the SEC reports filed
by Immunex, including
the most recently filed Form 10-Q.
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
www.immunex.com.