Investigational Cladribine Tablets Data Show Greater Treatment Effect in Relapsing MS Patients at a Higher Risk of Disease Progression

Darmstadt, Germany (ots/PRNewswire) -

- Subgroup analysis shows >80% reduction in the risk of disability
progression with Cladribine Tablets vs placebo

Merck, a leading science and technology company, announced the
presentation of new analyses of efficacy and safety data for
investigational Cladribine Tablets in poster presentations at the
Annual Meeting of the American Academy of Neurology (AAN), taking
place April 22 - 28, 2017, in Boston, Massachusetts.

(Logo: http://mma.prnewswire.com/media/492737/Merck_Logo.jpg)

The findings from a retrospective subgroup analysis of the Phase
III CLARITY trial in 289 patients with high disease activity*
demonstrated statistically significant reduction in the risk of
disability progression and relapse with Cladribine Tablets at a dose
of 3.5mg/kg (n=140) compared with placebo (n= 149) in relapsing
multiple sclerosis (MS) patients who were either treatment naïve or
had prior disease modifying drug (DMD) exposure.

"We know that a proportion of patients with MS have a higher risk
of relapse and disability progression than the broader population,"
said Prof. Gavin Giovannoni, a lead investigator in the CLARITY
studies and Chair of Neurology, Barts and The London School of
Medicine and Dentistry. "These data are important since they indicate
that patients in the high disease activity subgroup treated with
Cladribine Tablets showed a greater response than that seen in the
overall CLARITY trial population."

The analysis demonstrated that treatment with Cladribine Tablets
3.5 mg/kg was associated with a larger reduction in the risk of
6-month confirmed EDSS progression in patients with high disease
activity (82%; P=0.0001) than observed in the overall CLARITY
population (47%; P=0.0016) vs placebo. Additionally, data showed that
Cladribine Tablets reduced the relative risk of annualised relapse
rate in patients with high disease activity (67%; P<0.0001) compared
with the overall CLARITY population (58%; P=<0.0001). The study found
that relapse and treatment history as well as MRI characteristics can
help to identify patients who are at increased risk of experiencing
relapses and disability progression.

"Cladribine Tablets is thought to selectively target the adaptive
immune response in MS, and may be able to address a medical need in
those patients already at higher risk of disability progression or
relapses," said Luciano Rossetti, Head of Global R&D for the
biopharma business of Merck.

A safety analysis of patients given Cladribine Tablets for 20 days
over two years in either CLARITY or CLARITY Extension showed that,