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News breaking: 2017-06-24

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

DARMSTADT, Germany, June 24, 2017 /PRNewswire/ -- 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(R) (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(R)

Rebif(R) (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(R) in chronic progressive MS has not been established. Interferon ss is thought to help reduce inflammation. The exact mechanism is unknown.

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

Rebif(R) can be administrated with the RebiSmart(R) electronic auto-injection device (not approved in the US), or with the RebiDose(R) single-use disposable pen, or the manual multidose injection pen RebiSlide(TM). Rebif(R) can also be administered with the autoinjector Rebiject II(R) 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(R) in early multiple sclerosis. The extension of the indication of Rebif(R) has not been submitted in the United States.

Rebif(R) 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(R) with their doctors.

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

Rebif(R) (interferon beta-1a) is approved in the United States for relapsing forms of MS. RebiSmart(R), an electronic device for self-injection of Rebif(R), 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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