New multiple sclerosis drugs set to capture market share

The Russian approval of Merck Serono’s Movectro (oral cladribine) is a landmark in the treatment for relapse-remitting multiple sclerosis (RRMS) patients, as it becomes the world’s first oral disease-modifying MS therapy to be granted marketing authorisation beating Novartis’s Gilenia (fingolimod).

Without Tysabri and Extavia launching, Movectro will become the first new MS therapy to enter the US$200m Russian MS market in over a decade and this bodes well for European approval expected in the third quarter of 2010.

While winning the race for European approval, Datamonitor expects Movectro will lose out to Gilenia in the race to become the first oral MS therapy in the US.

In June 2010, Gilenia received unanimous backing by FDA advisors to be approved for RRMS patients and this news comes as a blow to Merck Serono, days after it announced the resubmission of oral cladribine.

However, despite concerns over safety, Datamonitor believe these oral drugs are set to become the leading MS therapies by 2014. Currently Gilenia has the advantage of being recommended as a first-line therapy by the FDA advisory panel supported by robust clinical trial data.

At this stage it is unclear whether Movectro will receive the same backing. Datamonitor forecast seven major market sales of US$2.4bn and US$820m for Gilenia and Movectro, respectively at the end of the forecast period in 2019.

Trung Huynh, healthcare analyst at Datamonitor, comments: “Approval of Movectro in Russia is an important milestone for the MS market and will open the floodgates for other oral therapies. These new drugs will rapidly capture market share in this lucrative market and are set to be key growth drivers in the mid-term. The seven major MS market value is set to peak at US$9.5bn in 2014.”