May 30th, 2003
By Naomi Aoki, Globe Staff
The Boston Globe
Each seeking an advantage in the fierce marketing battle over multiple sclerosis drugs, Serono SA plans to release study results today that confirm its drug Rebif is more effective in preventing relapses after 63 weeks of therapy, while Biogen Inc. yesterday said it won regulatory approval to sell a prefilled syringe version of top-selling rival Avonex.
Cambridge-based Biogen is defending Avonex's position as the leading multiple sclerosis drug in the $1.3 billion US market. Rebif, made by Switzerland's Serono and jointly marketed by New York drug giant Pfizer Inc., won US approval in March 2002 based on study results showing it was more effective than Avonex in preventing relapses after 24 weeks of therapy.
The new results from the head-to-head trial comparing Rebif to Avonex showed that 56 percent of patients on Rebif remained relapse-free after 63 weeks compared to 48 percent of patients on Avonex, Serono said, confirming earlier results after 24 weeks and 48 weeks of treatment. The study followed more than 600 patients for 63 weeks.
''We're delighted with the data,'' said Deborah Brown, Serono's executive vice president in charge of the neurology unit. ''The earlier results are holding up.''
The data show Rebif has a competitive edge, analysts said, but it also shows that edge is slipping over time. After 24 weeks, Rebif fared better than Avonex by 12 percentage points. After 48 weeks, that difference had slipped to 10 percentage points, and the latest data show its edge has fallen to 8 percentage points.
Because multiple sclerosis is a lifelong disease, Biogen argues the effectiveness of treatments must also be compared over longer periods of time. Some physicians believe Rebif's initial advantage will wane after three to five years of treatment, making Avonex a better option for the long haul. Others argue that Rebif, which like Avonex is a version of the protein beta interferon, is more effective because it is given at a higher dose.
''At first blush, this may seem like good news for Serono,'' said Jennifer Chao, an analyst with RBC Capital Markets in New York. ''But this data is actually a good defense for Avonex.''
In a separate development, Biogen said it won approval for a more convenient prefilled syringe version of Avonex. Rebif is already available in a prefilled syringe so that patients don't have to mix the drug before injecting it. The prefilled syringe of Avonex will be available beginning in August, the company said.
Shares of Biogen fell 69 cents to $41.68. Shares of Serono rose 25 cents
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