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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.