Thursday December 3, 12:33 pm Eastern Time
By Ransdell Pierson
NEW YORK, Dec 3 (Reuters) - Immunex Corp. said delayed 20 mins - Thursday it would seek the FDA's permission in the disclaimer second quarter to expand the use of its drug Novantrone for the treatment of patients with progressive multiple sclerosis.
Seattle-based Immunex said it would require expedited review of data from the drug's European trials with MS patients. Expedited review involves six months of scrutiny by the FDA, or U.S. Food and Drug Administration, instead of the usual 12-month review.
The company's shares were 6 higher at 101-9/16 early Tuesday afternoon on the Nasdaq, after climbing to a 52-week high of 104-1/8 earlier in the session.
Immunex has marketing rights to Novantrone in North America. American Home Products (NYSE:AHP - news), based in Madison, N.J., has marketing rights to Novantrone outside North America.
The company had announced in September that a Phase III trial of the drug, which is already sold for prostate cancer, delayed relapses in MS patients.
There had been some uncertainty whether the FDA would accept the European MS trial data on Novantrone, known generically as mitoxantrone.
"The fact that Immunex is planning its supplemental NDA (new drug application) of Novantrone for MS indicates the FDA has told the company it will accept the European data, " said Michael King, a pharmaceuticals analyst for BancBoston Robertson Stephens, which is hosting a conference in New York.
King said the new MS indication, if granted by the FDA, could give the drug potential additional global sales of between $1 billion and $1.5 billion within 5 years.
Kris Jenner, the drug analyst for T. Rowe Price Associates, had a more modest view that Novantrone could earn perhaps only another $200 million to $300 million annually within five years if it obtained the MS indication.
The drug is a chemotherapy agent that causes serious side-effects such as hair loss and gastrointestinal problems and that most neurologists would only prescribe it for the most seriously ill patients, Jenner said.
He said Biogen Inc. (Nasdaq:BGEN - news) sells the current "flagship" drug for MS, Avonex, which he estimated would have 1998 global sales of $350 million to $400 million.
Avonex is used to treat less seriously ill MS patients, in particular those who have flare-ups and then remissions of symptoms, he said. Novantrone, by contrast, would be used to treat progressive patients who have unremitting serious complications from the disease.
Immunex will seek the FDA approval of Novantrone for MS based on a Phase III trial of 194 patients. It showed the median time to the first relapse was 24 months for those taking the drug compared to 15 months for MS patients taking placebos, or dummy pills.
The trial showed the annual relapse rate for those on Novantrone was 21 percent or 36 percent depending on dosage compared with 60 percent in the placebo group.
Multiple sclerosis is a paralyzing illness that attacks the nervous system and, according to King, affects 250,000 people in the United States and over 500,000 worldwide.
In November, Immunex received FDA approval for the first in a new class
of drugs to treat rheumatoid arthritis, Enbrel, which works by inhibiting
tumor necrosis factor (TNF). Its marketing partner for Enbrel is American
Home Products, based in of New Jersey.
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