Company seeks priority review of NOVATRONE in secondary progressive Multiple Sclerosis
SEATTLE - Immunex Corporation (NASDAQ:IMNX) announced today that it has filed a supplemental NDA with the U.S. Food and Drug Administration (FDA) for expanded labeling for NOVANTRONE® (mitoxantrone for injection concentrate) for the treatment of patients with secondary progressive Multiple Sclerosis (MS).
"There are 120,000 patients with secondary progressive MS for whom there are still no approved treatment options," said Peggy V. Phillips, senior vice president, pharmaceutical development for Immunex. "Patients with this form of the disease experience a steady worsening of their neurological function which can result in loss of control over movement of limbs and impaired vision and speech. We are pleased to be filing this and we have asked the FDA for priority review."
The results of the pivotal NOVANTRONE Phase III data submitted to the FDA today showed that NOVANTRONE had a statistically significant impact on relapse rate and disability progression in patients with secondary progressive MS. These clinical data were corroborated by positive magnetic resonance imaging (MRI) data.
This multicenter, placebo-controlled, randomized, observer-blind study of 194 patients compared two doses of NOVANTRONE -- 12 mg/m2 and 5 mg/m2 - with placebo. Each treatment was administered by short, IV infusion once every three months for two years. These results were reported at the September 1998 Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Additional third-year follow-up data were presented in April of this year at the Annual Meeting of the American Academy of Neurology (AAN). These results showed that one year after treatment was stopped, patients who had been treated with NOVANTRONE experienced a sustained reduction in their number of attacks, and delay in their disability progression, compared to patients treated with placebo.
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 afflicts 300,000 to 350,000 people in the United States. The symptoms of MS result when inflammation and breakdown occur in myelin, the fatty substance that insulates the nerve fibers of the brain and spinal cord. This substance helps conduct the flow of nerve impulses to and from the brain. In people with MS, the myelin is damaged, causing patches of scar tissue, or "sclerosis," which interferes with the body's ability to transport messages from the brain to body parts, thereby inhibiting body functions and movement. 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.
Initial studies in animal models showed NOVANTRONE helped prevent disease relapse and progression. These preclinical studies led to further studies of NOVANTRONE in patients with MS. Several Phase I and II trials were conducted that showed a reduction in new lesions on MRI, as well as reductions in the number and severity of relapses in patients treated with NOVANTRONE.
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-K.
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.