Merck Presents New Data Examining Durable Efficacy with Investigational Cladribine Tablets in Multiple Sclerosis

Not intended for UK-based media.

DARMSTADT, Germany, September 16, 2016 /PRNewswire/ - Merck, a leading science and technology company, announced they presented new efficacy data for investigational Cladribine Tablets in two oral presentations at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) taking place September 14-17, 2016, in London. The findings, from the phase III CLARITY and CLARITY EXTENSION trials and from the open-label maintenance period of the phase III ORACLE-MS study, demonstrated durable efficacy of Cladribine Tablets in patients with multiple sclerosis (MS) along with a well-characterized safety profile. CLARITY and CLARITY EXTENSION studies confirmed that 20 days of oral dosing over two years was effective in reducing the frequency of relapses and slowing disability progression for up to four years.

"The results presented this week show that the clinical benefits of Cladribine Tablets can be maintained in most patients for an additional two years without the need for redosing," said Dr. Giancarlo Comi, Professor of Neurology, Chairman of the Department of Neurology, and Director of the Institute of Experimental Neurology, at Vita-Salute San Raffaele University, Scientific Institute San Raffaele, Milan and a lead investigator in the studies. "Although multiple therapies are available for patients with MS, there is still a large unmet need within this patient community, including for therapies that offer lasting benefits."

In one oral presentation, data from the two-year phase III CLARITY trial and its two-year extension study (CLARITY EXTENSION) showed that patients with relapsing MS who received placebo in CLARITY and were switched to Cladribine Tablets in CLARITY EXTENSION had significantly reduced annualised relapse rates (ARR) (0.26 vs. 0.10, P