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.

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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,
following the 10-day dosing period in treatment year 1, median
lymphocyte counts were reduced to a low of 1.00×10[9]/L. However, by
the end of treatment year 1 and 2, median lymphocyte counts had
recovered to within the normal range. In the 2-year CLARITY study,
the most commonly reported adverse event (AE) in patients treated
with Cladribine Tablets was lymphopenia. The incidence of infections
was 48.3% with Cladribine Tablets and 42.5% with placebo, with 99.1%
and 99.0% respectively rated mild-to-moderate by investigators.

*Higher risk of disease progression and/or high disease activity
is defined as patients with >= 1 relapse during the year prior to
study entry while on DMD therapy AND >= 1 T1 Gd+ or >= 9 T2 lesions
plus patients with >= 2 relapses during the year prior to study
entry, regardless of prior use of DMD.

About Cladribine Tablets

Cladribine Tablets is an investigational short-course oral therapy
that is thought to selectively and periodically target lymphocytes
thought to be integral to the pathological process of MS. Cladribine
Tablets is currently under clinical investigation and not yet
approved for the treatment for any use in the United States, Canada
and Europe. In July 2016, the European Medicines Agency (EMA)
accepted for review the Marketing Authorisation Application (MAA) of
Cladribine Tablets for the treatment of relapsing remitting multiple
sclerosis.

The clinical development program for Cladribine Tablets includes:

- CLARITY (CLAdRIbine Tablets Treating MS OrallY) study and its
extension: a two-year Phase III placebo-controlled study designed
to evaluate the efficacy and safety of Cladribine Tablets as a
monotherapy in patients with RRMS and its two-year extension
designed to provide data on the long-term safety and efficacy of
extended administration of Cladribine Tablets for up to four years.
- ORACLE MS (ORAl CLadribine in Early MS) study: a two-year Phase III
placebo-controlled study designed to evaluate the efficacy and
safety of Cladribine Tablets as a monotherapy in patients at risk
of developing MS (patients who have experienced a first clinical
event suggestive of MS).
- ONWARD (Oral Cladribine Added ON To Interferon beta-1a in Patients
with Active Relapsing Disease) study: a Phase II placebo-controlled
study designed primarily to evaluate the safety and tolerability of
adding Cladribine Tablets treatment to patients with relapsing
forms of MS, who have experienced breakthrough disease while on
established interferon-beta therapy.
- PREMIERE (Prospective Observational Long-term Safety Registry of
Multiple Sclerosis Patients Who Have Participated in Cladribine
Clinical Studies) study: interim long-term follow-up data from the
prospective registry, PREMIERE, to evaluate the safety and efficacy
of Cladribine Tablets. The follow-up will consist of over 10,000
patient years of exposure in total, with follow-up in some patients
exceeding eight years at completion.

About Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of
the central nervous system and is the most common, non-traumatic,
disabling neurological disease in young adults. It is estimated that
approximately 2.3 million people have MS worldwide. While symptoms
can vary, the most common symptoms of MS include blurred vision,
numbness or tingling in the limbs and problems with strength and
coordination. The relapsing forms of MS are the most common.

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About Merck

Merck is a leading science and technology company in healthcare,
life science and performance materials. Around 50,000 employees work
to further develop technologies that improve and enhance life - from
biopharmaceutical therapies to treat cancer or multiple sclerosis,
cutting-edge systems for scientific research and production, to
liquid crystals for smartphones and LCD televisions. In 2016, Merck
generated sales of EUR 15.0 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and
chemical company. The founding family remains the majority owner of
the publicly listed corporate group. Merck holds the global rights to
the Merck name and brand. The only exceptions are the United States
and Canada, where the company operates as EMD Serono, MilliporeSigma
and EMD Performance Materials.

ots Originaltext: Merck KGaA
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