Merck to Present Data on Rebif® (interferon beta-1a) and Cladribine Tablets for Multiple Sclerosis at 2nd Congress of the European Academy of Neurology

DARMSTADT, Germany, May 25, 2016 /PRNewswire/ - Merck, a leading science and technology company, today announced that clinical data on Rebif® (interferon beta-1a), the company's high-dose, high-frequency interferon beta for relapsing forms of multiple sclerosis, and Cladribine Tablets, an investigational, oral, small molecule for the treatment of relapsing-remitting multiple sclerosis (RRMS), will be presented at the 2nd Congress of the European Academy of Neurology (EAN), taking place May 28-31, 2016, in Copenhagen, Denmark.

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For Rebif®, interim results from two non-interventional studies of adherence patterns in patients with RRMS using the RebiSmart® device and the RebiSTAR® patient service program will be presented. Long-term clinical and radiological data from a retrospective, observational study of patients with RRMS in Spain who were treated with Rebif® for more than 10 years will also be presented. Finally, a presentation will take place of a retrospective analysis of real-world data describing factors for Rebif® discontinuation over time among patients with RRMS.

For Cladribine Tablets, a re-analysis exploring the effect of Cladribine Tablets in patients who would now be classified as having early MS will be presented. Also, results from an exploratory analysis of the CLARITY study evaluating the effect of Cladribine Tablets on brain atrophy rates in patients with RRMS will be presented. Additionally, final safety and tolerability results will be presented from the phase II ONWARD study, which evaluated Cladribine Tablets when added to interferon beta-1a therapy in patients with active relapsing MS.

"Merck looks forward to sharing additional data with the scientific community for Rebif® and Cladribine Tablets in MS," said Luciano Rossetti, Global Head of Research & Development for Merck's biopharma business. "The Company's scientific presence at this year's congress, and the Rebif® and Cladribine Tablets data presented, underscore our strong commitment to the MS community and to advancing patient care."

The following seven abstracts have been accepted for presentation at EAN (Central European Time):

Abstracts at a Glance

All posters will be available throughout the congress on the poster screens and poster stations in the exhibition area.

Abstract 1178; May 29, 2016, 12:30-13:15

Adherence to Subcutaneous Interferon Beta-1a in Patients Participating in the RebiSTAR® Patient Service Program: Interim Analysis of the Non-Interventional Study RebiSTART; A. Chan

Location: Screen F1

Abstract 1137; May 30, 2016, 12:30-13:15

Interim Analysis of the Non-Interventional Study REBIFLECT: Adherence to Subcutaneous Interferon ?-1a in Patients Using RebiSmart®-Logged Data and Their Reflection in Doctor-Patient Interviews; P. Rieckmann

Location: Screen F2

Abstract 616; May 30, 2016, 12:30-13:15

Observational, Retrospective Study to Characterize Patients with RRMS and Long-Term Treatment with SC Interferon (IFN) Beta 1-a; J.R. Ara

Location: Screen F1

Abstract 657; May 30, 2016, 13:30-14:15

Reasons for Subcutaneous Interferon Beta-1a Three Times a Week Discontinuation Among Patients with Multiple Sclerosis: a Real-World Retrospective Cohort Study; M. Sabidó-Espin

Location: Screen F2

Abstract 1380; May 30, 2016, 12:30-13:15

A Retrospective Analysis of Efficacy in McDonald 2010 Multiple Sclerosis (MS) Patients in the ORACLE-MS Study; M.S. Freedman

Location: Screen F1

Abstract 1105; May 29, 2016, 13:30-14:15

Effect of Cladribine Tablets on Brain Atrophy Rates in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS): Exploratory Analysis of the CLARITY Study; N. de Stefano

Location: Screen F1

Abstract 1209; May 29, 2016, 12:30-13:15

Safety and Tolerability of Cladribine Tablets Added to IFN-Beta Therapy in Patients with Active Relapsing Multiple Sclerosis: Final Results from the ONWARD Study (Amended Protocol); X. Montalban

Location: Screen F2

Learn more about Merck's programs, pipeline and activities in neurology by visiting our booth at this year's congress.

About Cladribine Tablets

Cladribine Tablets is an oral small molecule that targets the immune cells thought to be integral to the pathological process of MS. Cladribine Tablets is currently under clinical investigation and not approved for any use in the United States, Canada and Europe.

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™. 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 two million patients 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 2015, Merck generated sales of € 12.85 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, Darmstadt, Germany 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.

Source: Merck

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