Swiss biotechnology company, Serono, says it has started a two-year head-to-head clinical trial pitting its top-selling multiple sclerosis offering, Rebif (interferon beta-1a), against Teva’s rival product, Copaxone (glatiramer).
Over 700 patients with relapsing remitting MS who have not been treated with disease modifying therapies have been enrolled in the study, which is comparing the two products’ efficacy. The primary outcome of the trial is time to first relapse, but the study will also assess brain scans and disability progression.
“We believe that a head-to-head trial is necessary to provide scientific data that can be used to compare different therapeutic options,” said Serono’s chief medical officer, Paul Lammers. “We expect the data to support Rebif as the foundation therapy for treatment of multiple sclerosis,” he added.
This is not the first time that Serono has put its neck on the line in a head-to-head trial, having succeeded in getting Rebif on the US market back in 2002 after showing it was more effective than the orphan drug holder, Biogen’s Avonex, also interferon beta-1a [[08/03/02a]]. And the Swiss company is no doubt keen to maintain the reputation of its MS offering, which is expected to face increased market competition from Elan and Biogen Idec’s Tysabri (natalizumab) – formerly known as Antegren – which won US approval towards the end of last year [[24/11/04a]]. The latter two companies have already announced plans to start a trial comparing the effects of Tysabri and Rebif on the rate of clinical relapse [[22/12/04a]].