By Ronald Rosenberg, Globe Staff, 10/06/99
Seeking to prove that its drug is more effective in treating multiple sclerosis than Avonex, the leading medication from Biogen Inc., a Swiss biotechnology company yesterday said it has launched a 600-patient comparison trial.
Ares-Serono Group SA, Europe's largest biotech company, said it began the evaluation because it is barred in the United States from marketing its drug, called Rebif, under provisions of the Orphan Drug Act. That federal law gives drug manufacturers, such as Biogen, seven years of exclusive marketing protection along with tax incentives if they are the first to develop treatments for rare diseases.
Ares-Serono is seeking to prove that Rebif is a more effective drug if given in significantly higher doses than Avonex.
Biogen officials declined to comment on Ares-Serono's study, although company spokeswoman Kathryn R. Bloom questioned the ''scientific rigor'' of Ares-Serono's one-year trial. ''This is a marketing trial, one which we are leery of,'' she said.
The decision to launch a head-to-head comparison, which an Ares-Serono official estimated will cost more than $25 million, follows a US Food and Drug Administration ruling in March that both drugs were identical in chemical composition.
Last year Biogen reported $395 million in Avonex sales with Wall Street analysts expecting revenues to easily surpass the $500 million mark this year. One reason for the drug's hefty growth is that physicians put patients who are diagnosed early with multiple sclerosis on Avonex well before the most serious symptoms appear.
Ares-Serono, which has US headquarters in Norwell, asserts that Rebif is the market leader in Canada and that worldwide sales of the drug are around $100 million, according to Hisham Samra, Serono's head of clinical development and regulatory affairs.
''We are measuring the flareups or episodes MS patients have and lesions in the brain using an MRI [magnetic resonance imaging] scan and believe our higher dose is better,'' said Samra, adding that by the end of 2000 worldwide sales of multiple sclerosis drugs will reach $2 billion.
Bloom said Ares-Serono is not measuring the disabilities of each patient, a critical endpoint that Samra said would take two years to evaluate rather than the single year for episodes and an MRI lesion scan.
Ares-Serono is asserting that a higher dose of Rebif - 142 micrograms injected three times a week into the bloodstream - is more effective than the current Avonex regimen of 30 micrograms given in a single intramuscular injection every week.
The large comparison trial of both drugs, which are known as interferon beta-1a, has the backing of the New York-based National Multiple Sclerosis Society.
''This study will provide important information for MS patients and
their physicians and will allow a direct assessment of the dose-response
theory in use of interferon beta-1a,'' said Stephen Reingold, vice president
of research at the MS Society. ''We eagerly await the results of this study.''
This story ran on page D06 of the Boston Globe on 10/06/99.
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