Merck to Present Rebif® (interferon beta-1a) and Investigational Cladribine Tablets Data at AAN 2017

Published: April 21, 2017; 15:47 · (FriedlNews)


- Breadth of data and activities underscore company's long-standing
commitment to enhancing care for people with MS

Merck, a leading science and technology company, will present data at
the American Academy of Neurology (AAN) 69th Annual Meeting, taking
place from April 22-28, 2017, in Boston, Mass. Merck will present 15
abstracts on multiple sclerosis (MS), including studies evaluating
Rebif® (interferon beta-1a) and investigational Cladribine Tablets,
as well as analyses of complications and MS relapse rates during
pregnancy and real-world data related to the impact of treatment
adherence and patient costs.

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

"Rebif has a well-established safety profile supported by more than
20 years of accrued clinical trial and patient experience, and the
information from the studies and analyses we are presenting at AAN
deepens our understanding of this important RRMS therapy," said Dr.
Kathleen Hawker, Vice President, Neurology and Immunology US, EMD
Serono, the biopharmaceutical business of Merck KGaA, Darmstadt,
Germany.

The company will also present efficacy and safety data for Cladribine
Tablets, an investigational short-course oral therapy that is thought
to selectively and periodically target lymphocytes which may 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 or elsewhere. In
July 2016, the European Medicines Agency (EMA) accepted for review
the Marketing Authorisation Application (MAA) of Cladribine Tablets
for the treatment of adult patients with RRMS.

"We have an unwavering focus on delivering innovation to patients in
need, and our presentations this week at AAN, a leading neurology
conference, further validate the promise of Cladribine Tablets as a
potential RRMS treatment option," said Luciano Rossetti, Head of
Global R&D for the biopharma business of Merck.

Attendees can learn more about our programs, pipeline and activities
in neurology by visiting our medical booth #473. Booth activities
include a $25,000 charitable donation presentation to Can DO MS on
April 25 at 3 p.m., as well as "I'm Facing MS" simulation stations
that will translate users' experiences with different MS impairments
into artwork.

AAN Brain Health Fair

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt,
Germany, in the US and Canada will have an exhibition at the AAN
Brain Health Fair on April 21 from 10 a.m. - 4 p.m. ET, where
attendees can gain first-hand experience about what it's like to have
MS through virtual reality and other activities.

The following abstracts were accepted for presentation at the AAN
2017 Annual Meeting:

Rebif (interferon beta-1a) Presentations
Abstract/
Presentation
Title Lead Author Poster #
Date/Time/Session
Cholecalciferol W. Camu 004 April
27, 2017, 4:06 p.m.
Supplementation in Oral
Presentation
Relapsing Multiple Session
S44: MS Risk
Sclerosis Patients Treated Factors
and Modifications
with Subcutaneous
Interferon Beta-1a: A
Randomized Controlled
Trial
High Dose Cholecalciferol R. Hupperts 005 April
27, 2017, 4:18 p.m.
(Vitamin D3) Oil as Add-on Oral
Presentation
Therapy in Subjects with Session
S44: MS Risk
Relapsing-Remitting
Multiple Sclerosis
Receiving Subcutaneous
Interferon ss-1a
(scIFNbeta-1a)
Treatment with Interferon M. Battaglini 340 April
28, 2017, 4:00 -
Reduces the Appearance of 5:30
p.m.
Lesions in Clinically Poster
Session P6
Relevant White Matter (WM)
Tracts in Patients with
Clinically Isolated
Syndrome (CIS)
Effect of Early Versus M. Freedman 358 April
28, 2017, 4:00 -
Delayed Treatment (DT) 5:30
p.m.
with Subcutaneous IFN Poster
Session P6
ss-1a (scIFNss-1a) on
Radiological Activity Free
(RAF) or Clinical Activity
Free (CAF) Status in
Patients with Clinically
Isolated Syndrome (CIS): A
Post-hoc Analysis of
REFLEXION
Clinical Efficacy of F. Nelson 343 April
28, 2017, 4:00 -
Interferon ss-1a 5:30
p.m.
Subcutaneously Three Times Poster
Session P6
Weekly According to
Baseline Radiological
Characteristics: Post Hoc
Analyses of PRISMS Data
Efficacy of Interferon E. Williamson 329 April
28, 2017, 4:00 -
ss-1a Subcutaneously Three 5:30
p.m.
Times Weekly According to Poster
Session P6
Baseline EDSS/Duration,
EDSS, and MSSS Sub-groups:
Post Hoc Analysis of
PRISMS Data

Cladribine Tablets Presentations
Abstract/
Presentation
Title Lead Author Poster #
Date/Time/Session
Cladribine Tablets in the S. Cook 394 April
27, 2017, 5:30 -
Treatment of Patients with 7:00
p.m.
Multiple Sclerosis (MS): Poster
Session P5
An Integrated Analysis of
Safety from the MS
Clinical Development
Program
Absolute Lymphocyte Count P. 379 April
27, 2017, 5:30 -
Recovery in Patients with Soelberg- 7:00
p.m.
Relapsing-Remitting Sorensen Poster
Session P5
Multiple Sclerosis (RRMS)
Treated with Cladribine
Tablets 3.5 mg/kg in
CLARITY and CLARITY
Extension
Cladribine Tablets in the G. Comi 349 April
28, 2017, 4:00 -
ORACLE-MS Study Open-label 5:30
p.m.
Maintenance Period: Poster
Session P6
Analysis of Efficacy in
Patients after Conversion
to Clinically Definite
Multiple Sclerosis (CDMS)
Defining High Disease G. Giovannoni 351 April
28, 2017, 4:00 -
Activity (HDA) in Patients 5:30
p.m.
with Relapsing Multiple Poster
Session P6
Sclerosis (RMS) Receiving
Placebo in the CLARITY
Study
Durable Efficacy of G. Giovannoni 353 April
28, 2017, 4:00 -
Cladribine Tablets in 5:30
p.m.
Patients with Multiple Poster
Session P6
Sclerosis: Analysis of
Relapse Rates and
Relapse-free Patients in
the CLARITY and CLARITY
Extension Studies
Efficacy of Cladribine G. Giovannoni 360 April
28, 2017, 4:00 -
Tablets 3.5 mg/kg in High 5:30
p.m.
Disease Activity (HDA) Poster
Session P6
Subgroups of Patients with
Relapsing Multiple
Sclerosis (RMS) in the
CLARITY Study

Additional Company-Sponsored Presentations
Abstract/
Presentation
Title Lead Author Poster #
Date/Time/Session
Multiple Sclerosis Relapse A. Phillips 361 April
23, 2017, 4:00 -
Rates, Before, During, and 5:30
p.m.
After Pregnancy: A US Poster
Session P1
Retrospective Claims
Database Analysis
Pregnancy Complications of MK. Houtchens 110 April
24, 2017, 8:30
Women With and Without a.m. -
7:00 p.m.
Multiple Sclerosis in a Poster
Session P2
Large US Claims Database
Does Patients' Experience J. Smrtka 337 April
25, 2017, 5:30 -
of Care Differ by Level of 7:00
p.m.
Adherence in Multiple Poster
Session P3
Sclerosis?

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 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.

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