Merck KGaA, one of the leaders in the race to get an oral multiple sclerosis drug to market, has presented promising late-stage data on cladribine, which has also received a vote of confidence in a survey of neurologists.

The German company presented data from the two-year Phase III CLARITY study at the European Committee for Treatment and Research in Multiple Sclerosis congress in Dusseldorf. The findings revealed that 43% and 44% of patients with relapsing-remitting MS treated with cladribine, on a total dose of 3.5 mg/kg and 5.25 mg/kg respectively, had absence of disease activity, compared with 16% on placebo.

Peter Rieckmann, an investigator in the CLARITY study, noted that the analysis is very encouraging, based on the comparison between short-course oral treatment with cladribine and placebo, “with only 8-20 days of treatment in the first year of study and only 8-10 days of treatment in the second year.” Merck submitted a marketing authorisation application to the European Medicines Agency for the drug in July and a filing in the USA is planned during this quarter.

Meantime, a report from Decision Resources stated that nearly 90% of surveyed neurologists indicate they will prescribe cladribine, a higher percentage than those willing to prescribe certain potential rival treatments, namely Biogen Idec's BG-12 and Novartis/Mitsubishi Tanabe's FTY-720 (fingolimod). Analyst Bethany Kiernan said that the 102 people surveyed “will prescribe these emerging oral therapies to about one-fifth of secondary progressive MS patients”.

However she added that, despite the similarities in projected prescribing patterns among these therapies, “our findings indicate that oral cladribine will be favoured over FTY-720 as well as BG-12, suggesting that clinicians have begun to differentiate these oral agents from one another”.