The prospect of an orally active treatment for multiple sclerosis patients has taken a step nearer with the start of Phase III trials of Mylinax (cladribine) by Ivax of the US and Switzerland’s Serono later this quarter.
At present, all the available treatments for MS – the beta interferons from Serono, Biogen Idec and Schering AG, Teva’s Copaxone (glatiramer acetate) and the recently introduced Tysabri (natalizumab) from Elan and Biogen Idec – are given by injection or infusion, and an oral treatment is likely to make hundreds of millions of dollars in sales, providing it can show that it is not inferior to current therapies. A recent report by Datamonitor estimated that new oral therapies for MS would help drive the market towards the $6 billion mark by 2012 – more than double its 2003 value of $2.8 billion [[19/07/04h]].
But Serono and Ivax are going head-to-head with a number of other companies in the race to develop an oral therapy, including GlaxoSmithKline and Tanabe, which unveiled their own candidate – an integrin antagonist codenamed 683699 – last November [[25/11/04c]]. Another player in the oral MS treatment category is Teva, which is developing an oral formulation of Copaxone – due to reach the market after 2007. In June 2004, Teva also licensed an orally available, disease-modifying treatment for MS, laquinimod, from Swedish company Active Biotech. The latter is in Phase II testing. Moreover, Sanofi-Aventis is a little ahead of the field as its teriflunomide, an immunosuppressant in the same class as the firm’s rheumatoid arthritis drug Arava (leflunomide), started Phase III trials in early 2004.
The two-year Phase III Mylinax trial will enrol around 1,200 patients with relapsing forms of MS and look at the effects of the drug on clinical relapses, disability progression and MRI (magnetic resonance imaging) brain scans.