MS Updates this week

Key events occurred this week in the MS therapy space. First is Merck Serono terminated development of cladribine in RRMS. Merck Serono had received tough responses from both the EMA and FDA, even though Movectro (cladribine) was approved for marketing in Russia and Australia. In February 2011, Merck Serono withdrew its application from the EMA for cladribine in MS and in March, the FDA gave a complete response letter to Merck Serono asking for more information on cladribine in Merck Serono. According to Merck Serono's press release this week, the FDA had indeed asked for more clinical trials and predictably Merck Serono was not unsure of the benefit given the changing landscape in the oral MS therapy space.

The other key development was the approval for use of JCV Ab status as a third risk factor in the EU Tysabri SmPC. This was predicted after the CHMP gave a positive opinion in April 2011 to this effect. The EC also approved additional 5 year marketing authorization for Tysabri in the EU. This is a great boost for Biogen Idec as it positions itself for a re-launch of Tysabri in the EU and US later this year.

Clearly there is a lot happening in this area as some drugs move out of the race and we expect results from more drugs in the later half of this year. BG-12, alemtuzumab, Laquinimod, teriflunomide are some of the other drugs in the pipeline which are expected to present results later this year. In fact some of these results can be expected starting July - August 2011.