Serono reiterates EVIDENCE results in bid to enter US market with Rebif

Serono took the opportunity presented by the recent World Congress ofNeurology meeting in London, UK, to provide an additional look at the results of the EVIDENCE trial which the company hopes will prove compelling enough to overturn the orphan drug exclusivity held by Biogen for its Avonex (interferon beta-1a) multiple sclerosis treatment in the USA.

To achieve its goal, Serono needs to demonstrate clinically that its product, Rebif (interferon beta-1a) is superior to Biogen's drug. At the WCN, the firm presented data, first released earlier this year (Marketletter May 14), suggesting that patients treated with Rebif for 24 weeks had a 90% greater chance of remaining relapse-free than those taking Avonex, while 32% fewer Rebif patients suffered relapses compared with patients taking Avonex. Based on these results, Serono said it is planning to petition the US Food and Drug Administration "shortly" to approve the drug, perhaps by the middle of next year. Avonex has market exclusivity at present until the middle of 2003.

Injunction on releasing data