Thursday February 14, 06:30 PM
The FDA is considering whether to
terminate the orphan drug status of Biogen's Avonex.
If next month's FDA meeting gives the go-ahead, Serono will launch its rival multiple sclerosis treatment Rebif in the US straight away. Due to its superior trial results, Rebif could then bring the end of Avonex's global market dominance. This would be a serious setback for Biogen, which is heavily dependent on the drug's revenues.
The FDA is currently deciding whether or not to revoke the seven-year orphan drug status of Biogen's Avonex (interferon beta-1a) for relapsing forms of multiple sclerosis. The drug has been protected since its 1996 launch. Serono, which markets rival drug Rebif, is attempting to challenge this status. It released results in May 2001 from a head-to-head study indicating that Rebif reduced relapses by 32% more than Avonex. Patients had a 90% greater chance of remaining relapse-free during the 24-week treatment period with Rebif than with Avonex. The FDA is taking these results seriously.
Biogen has been unsurprisingly critical of Serono's trial. However, another head-to-head study from Italy has compared Schering AG's Betaferon (interferon beta-1b) with its main rival Avonex. These findings also support the view that high doses of interferon beta-1b therapy reduce disease activity more effectively than Avonex in patients with the relapsing-remitting form of the disease.
Betaferon, marketed as Betaseron in the US by Berlex Laboratories, has remained a close rival to Avonex. However, the latest Schering studies may not impact Avonex sales: early aggressive immunomodulatory treatment with interferon beta-1b remains controversial.
Due to its similar clinical profile, Rebif poses a more serious threat. Its sales grow by 49% in 2001, and it is the fastest growing treatment for relapsing-remitting multiple sclerosis outside the US. Additional indication approval for treating secondary progressive multiple sclerosis in Europe should increase its revenues still further.
Loss of protection would be a serious setback for Biogen. Avonex contributed 82% of its total revenues in 2000, as well as having a 45% share of the $1.7 billion MS treatment market. This is likely to change, as there is little reason why Rebif should not replicate its success in the US.
Biogen claims that its once-a-week
formulation of Avonex increases compliance in multiple sclerosis patients.
However, by the very nature of the disease, clinicians and patients are
more concerned with remaining relapse-free for as long as possible. This
may give Rebif the clinical advantage.
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