Merck to Present Data on MAVENCLAD(TM) (Cladribine Tablets) and Rebif® (interferon beta-1a) in Patients with Relapsing MS at EAN Congress 2017

Darmstadt, Germany (ots/PRNewswire) -

- New data builds on company's longstanding commitment to MS

Merck, a leading science and technology company, will present data
from its neurology and immunology portfolio at the 3rd Congress of
the European Academy of Neurology (EAN), taking place from June
24-27, in Amsterdam, the Netherlands. Merck will present a total of
12 abstracts on multiple sclerosis (MS), including studies evaluating
Rebif® (interferon beta-1a) as well as efficacy and safety data on
the use of MAVENCLAD(TM) (Cladribine Tablets), Merck's short-course
oral therapy recently recommended for marketing authorization by the
Committee for Medicinal Products for Human Use (CHMP) in patients
with relapsing MS.

(Logo: http://photos.prnewswire.com/prnh/20170421/492737LOGO )

Data being presented at the Congress will provide further insights
into the proposed mode of action of Cladribine Tablets, which is
thought to selectively target and discontinuously reduce lymphocytes
which may be integral to the pathological process of MS.

On 23 June, the Committee for Medicinal Products for Human Use
(CHMP) granted a positive opinion on the use of Cladribine Tablets
for highly active relapsing MS, and this recommendation has been
passed on to the EC to make the final decision on the Marketing
Authorization Application (MAA) later this year.

"We are pleased with the recent CHMP positive opinion, which takes
Cladribine Tablets a step closer to potentially benefitting patients
with this debilitating disease," said Luciano Rossetti, Head of
Global R&D for the biopharma business of Merck. "The data presented
at EAN provide a detailed characterization of the effect of
Cladribine Tablets on B and T lymphocytes in patients followed for up
to eight years and provide further support for the use of Cladribine
Tablets in patients with relapsing MS."

Attendees can learn more about Merck's programmes, pipeline and
activities in neurology by visiting our medical booth B30.

The following abstracts have been accepted for presentation at the
EAN Congress 2017:

Rebif (interferon beta-1a) Presentations
Abstract/
Presentation
Title Lead Author Poster #
Date/Time/Session

Evaluation of modified Rio M. Freedman PR2082 MS and
related
score (MRS) as a
disorders 3
predictive score in Sunday
June 25
clinical trial
13:30-14:15
sub-populations of
multiple sclerosis (MS)
patients treated
with subcutaneous
interferon beta 1-a

Patient adherence to G. de Voer POD506 Poster
on display
subcutaneous interferon session
beta-1a injections using
the RebiSmart(R) injection
device: A retrospective
real-world study among
Dutch and German patients
with multiple sclerosis

Impact of a patient V. Salgado EP3111 MS and
related
support program (REBICARE)
disorders 1
on interferon beta 1a Monday
June 26
adherence and clinical
12:30-13:15
outcomes in
Relapse-Remitting Multiple
Sclerosis

Oxidative stress in M. Moccia EP2166 MS and
related
multiple sclerosis: effect
disorders 4
of dietary supplementation Sunday
June 25
with coenzyme Q10
12:30-13:15

Cladribine Tablets Presentations
Abstract/
Presentation
Title Lead Author Poster #
Date/Time/Session

Efficacy of cladribine G. Comi EP1140 MS and
related
tablets in patients after
disorders 1
conversion to clinically
Saturday June 24
definite multiple
12:30-13:15
sclerosis (CDMS): analysis
of the ORACLE-MS study
open-label maintenance
period

Safety of cladribine S. Cook EP1141 MS and
related
tablets in the treatment
disorders 1
of patients with multiple
Saturday June 24
sclerosis (MS): an
12:30-13:15
integrated analysis from
the MS clinical
development program

Effect of cladribine G. Giovannoni POD040 Poster
on display
tablets on relapse rates session
and the proportions
qualified relapse-free in
patients with multiple
sclerosis: analysis of the
CLARITY and CLARITY
Extension studies

High Disease Activity G. Giovannoni EP1156 MS and
related
(HDA) Definitions in
disorders 2
Patients with Relapsing
Saturday June 24
Multiple Sclerosis (RMS)
12:30-13:15
Receiving Placebo in the
CLARITY Study

Cladribine tablets in high G. Giovannoni EP1157 MS and
related
disease activity (HDA)
disorders 2
subgroups from the CLARITY
Saturday June 24
study of patients with
12:30-13:15
relapsing multiple
sclerosis (RMS)

Absolute lymphocyte counts P. EP3120 MS and
related
in patients with Soelberg-Sorensen
disorders 6
relapsing-remitting Monday
June 26
multiple sclerosis (RRMS)
12:30-13:15
treated with cladribine
tablets 3.5 mg/kg in the
CLARITY and CLARITY
Extension studies

Selective and O. Stuve EP3122 MS and
related
discontinuous reduction of
disorders 6
B and T lymphocytes by Monday
June 26
cladribine tablets in
12:30-13:15
patients with early and
relapsing multiple
sclerosis (ORACLE-MS,
CLARITY and CLARITY
Extension)

Year-by-year lymphopenia S. Cook EP1142 MS and
related
rates in patients with
disorders 1
relapsing multiple
Saturday June 24
sclerosis (RMS) treated
12:30-13:15
with cladribine tablets
3.5 mg/kg in CLARITY and
re-treated in CLARITY
Extension

About MAVENCLAD(TM) (Cladribine Tablets)

Cladribine Tablets is a short-course oral therapy that is believed
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. On 23
June, the Committee for Medicinal Products for Human Use (CHMP)
granted a positive opinion on the use of Cladribine Tablets for
highly active relapsing MS, and this recommendation has been passed
on to the EC to make the final decision on the Marketing
Authorization Application (MAA) later this year.

The clinical development program for Cladribine Tablets includes:

- The CLARITY (CLAdRIbine Tablets Treating MS OrallY) study: 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.
- The CLARITY extension study: a four-year Phase III
placebo-controlled study following on from the CLARITY study,
designed to evaluate the safety and efficacy of Cladribine Tablets
over an extended administration for four years.
- 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 Rebif®

Rebif® (interferon beta-1a) is a disease-modifying drug used to
treat relapsing forms of multiple sclerosis (MS) and is similar to
the interferon beta protein produced by the human body. The efficacy
of Rebif® in chronic progressive MS has not been established.
Interferon ß is thought to help reduce inflammation. The exact
mechanism is unknown.

Rebif®, which was approved in Europe in 1998 and in the US in
2002, is registered in more than 90 countries worldwide. Rebif® has
been proven to delay the progression of disability, reduce the
frequency of relapses and reduce MRI lesion activity and area*.

Rebif® can be administrated with the RebiSmart® electronic
auto-injection device (not approved in the US), or with the RebiDose®
single-use disposable pen, or the manual multidose injection pen
RebiSlide(TM). Rebif® can also be administered with the autoinjector
Rebiject II® or by manual injection using ready-to-use pre-filled
syringes. These injection devices are not approved in all countries.

In January 2012, the European commission approved the extension of
the indication of Rebif® in early multiple sclerosis. The extension
of the indication of Rebif® has not been submitted in the United
States.

Rebif® should be used with caution in patients with a history of
depression, liver disease, thyroid abnormalities and seizures. Most
commonly reported side effects are flu-like symptoms, injection site
disorders, elevation of liver enzymes and blood cell abnormalities.
Patients, especially those with depression, seizure disorders, or
liver problems, should discuss treatment with Rebif® with their
doctors.

*The exact correlation between MRI findings and the current or
future clinical status of patients, including disability progression,
is unknown.

Rebif® (interferon beta-1a) is approved in the United States for
relapsing forms of MS. RebiSmart®, an electronic device for
self-injection of Rebif®, is also not approved in the United States.
Cladribine Tablets is an investigational product and not approved for
use in any indication in the United States.

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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