Friday, March 3, 2000
Immunex Corp.'s cancer drug Novantrone is close to approval by the Food and Drug Administration for use in a severe type of multiple sclerosis, the Seattle company said yesterday.
Immunex said the FDA had issued an "approvable letter," spelling out final conditions that must be met before the drug can be approved. The company said the agency had asked for more analysis of the data and was still working on final labeling for the drug.
If approved, Novantrone is unlikely to replace current MS therapies such as Biogen Inc.'s Avonex and Chiron Corp.'s and Schering AG's Betaseron. Instead, one analyst said, it will be used for patients who no longer respond to Avonex or Betaseron.
"It will likely be approved for people who have failed everything else, so it's clearly going to be a niche product," said ING Barings analyst Jonas Alsenas, who added that he expected the new use to add about $30 million to the drug's annual sales.
Still, the drug is inexpensive to produce so the profit margin will be large.
Novantrone, which already is used as a chemotherapy treatment for cancer, is considered more toxic than Avonex or Betaseron. Alsenas said he expected doctors to prescribe the drug only as a last resort, giving Immunex a small share of a $1 billion-a-year global market.
The drug is associated with side effects including lower white blood cell counts and heart problems, risks that increase with use.
The company said that it expected the drug's final approval to reflect an expert panel's recommendation in January that the FDA approve the drug for patients with secondary progressive MS, a severe form of the disease. Chiron is also seeking FDA approval of Betaseron for use in treating secondary-progressive MS. Like Avonex, it's now approved only for "relapse-remitting" MS, a form of the disease in which symptoms my ease or disappear for months.
Seattle-based Immunex shares rose $1.94 to close at $220.94 in Nasdaq trading.
About 350,000 people in the United States have MS, including talk-show
host Montel Williams. The company estimates that 140,000 of those patients
have the secondary progressive form of the disease.
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