FDA review of NOVANTRONE data to be completed within six months
SEATTLE-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 NOVANTRONER (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 in the 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 flare up 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 and for initial therapy of acute nonlymphocytic leukemia. It is not approved for use in MS patients. Full prescribing information for NOVANTRONE can be obtained by calling 1-800-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.
CONTACT:
Lisa Crisera (media)
206-389-4346
Mark Leahy (investors)
206-389-4363