Rebif Beats Avonex In Head-To-Head Trial

Tuesday, Serono (NYSE: SRA) released 48-week data from its head-to-head trial of Rebif against Biogen's (NASDAQ: BGEN) Avonex in the treatment of relapsing-remitting multiple sclerosis (RRMS). Both drugs are injectible recombinant interferon beta-1a proteins. Dr. Hillel Panitch, a University of Vermont College of Medicine researcher representing the EVIDENCE (EVidence for Interferon Dose-effect: European-North American Comparative Efficacy) Study Group, presented the findings at the annual meeting of the American Academy of Neurology (AAN). EVIDENCE is a prospective, randomized, open-label, single-blinded, comparative study enrolling 677  interferon-naïve RRMS patients in the U.S., Canada, and Europe.

The presentation indicates that, at 48 weeks, Rebif (44 mcg, three times per week) recipients had a statistically significant advantage over Avonex (30 mcg, weekly) recipients in terms of freedom from relapse, rates of occurrence of first relapse, and brain lesion counts as seen on magnetic resonance imaging (MRI).

Rebif's adverse effect profile was reassuring. Effects attributable to its more frequent administration (such as injection site reactions, liver function disorders, and white blood cell count changes) had a minimal, if any, impact on the proportion of patients discontinuing drug therapy.

Rebif is approved in over 70 countries, but had not been marketed in the U.S. prior to a month ago because of Avonex's former orphan drug exclusivity through May 2003. Avonex's exclusivity effectively ended in mid-March when the FDA approved Rebif for sale in the U.S. The controversial FDA decision was based, in large part, on 24-week EVIDENCE trial data demonstrating similar statistically significant Rebif advantages for these primary and secondary outcomes.

Though the long-term clinical meaning of these results remain at issue, there is no doubt that Rebif's magnitude of treatment effect, at this dosing schedule, has significant sustainability over 48 weeks. As both Rebif and Avonex will now compete in the U.S., Rebif's advantage after a year should still be monitored closely. Some people have been on Avonex for as long as a decade and are unlikely to switch. On the other hand, newly diagnosed individuals with RRMS are now even more likely to receive Rebif. How patients respond, long-term, to Rebif's less convenient administration regime (a 3-times per week injection protocol in the EVIDENCE trial versus the once-weekly Avonex shot) still remains to be seen.

Serono launched Rebif in mid-March, and has stated as its goal, "to capture more than a quarter of the [U.S.] market within four years." Serono will double its marketing expenses to approximately $60 million in 2002 to support the launch.

BTECH NEWS
by Leon Henderson, M.D.
Bennett Weintraub, Ph.D.
Christopher Martin
www.btechnews.com
April 18, 2002

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