Tuesday, January 25, 2000
WASHINGTON -- Seattle's Immunex Corp., the third-largest U.S. biotechnology company, will ask an expert U.S. government panel Friday to recommend approval of its cancer drug Novantrone for use in treating multiple sclerosis.
The U.S. Food and Drug Administration expert panel will weigh the safety and effectiveness of the drug in treating an advanced type of MS called secondary progressive multiple sclerosis.
Even if the new use is approved, analysts said Novantrone sales won't rival those of the company's biggest product, the arthritis drug Enbrel, though the new use could lift the company's shares.
"It's an incremental benefit for them to have an expanded label, but it's not going to be a turning point," said Elise Wang, a biotechnology analyst at PaineWebber.
Approval would vault Novantrone into a $1 billion-a-year market for MS drugs now dominated by Biogen Corp.'s Avonex, the world's best-selling treatment for the disease, and Schering AG's and Chiron Corp.'s Betaseron.
Both of those drugs are approved for relapsing-remitting MS, a less severe but more common form of the disease, and the agency is also reviewing Betaseron for use in secondary progressive MS.
Novantrone is associated with side effects including nausea, hair loss and infections. It's currently approved to treat pain in patients with advanced prostate cancer and as a first-line therapy for acute non-lymphocytic leukemia.
Immunex has said a study of 194 MS patients showed that Novantrone, taken by intravenous infusion every three months for two years, helped stem the progression of the disease. A follow-up study found that most patients didn't have a relapse in the year following the regimen.
Wang said she expected the panel to concentrate largely on the drug's side effects, though she said she expected the panel to recommend that the FDA approve the drug.
The FDA usually follows the advice of its expert panels.
About 350,000 people nationally -- including talk show host Montel Williams -- have MS, which is characterized by symptoms that range from numbness of the limbs to paralysis. The symptoms in relapsing-remitting patients may ease or disappear for months, while the 120,000 secondary progressive MS patients in the U.S. have symptoms that are more severe.
Immunex stock fell $21.56 to $110.06 yesterday amid a broad selloff
in the financial markets.