EMD Serono to Present Data Assessing Comparative Effectiveness of Rebif® (interferon beta-1a) vs. TECFIDERA® (dimethyl fumurate) at AAN Annual Meeting

ROCKLAND, Mass., April 14, 2016 /PRNewswire/ -- EMD Serono, the North America biopharmaceutical business of Merck KGaA, Darmstadt, Germany, today announced that clinical and real-world data about Rebif^® (interferon beta-1a), will be presented at the American Academy of Neurology's (AAN) 68th Annual Meeting, taking place April 15-21, 2016, in Vancouver, BC, Canada. Rebif is the #1 prescribed interferon for patients with relapsing forms of multiple sclerosis (MS) new to therapy and switching therapy combined.+

A real-world assessment of relapse rates in patients with MS newly initiating self-injectable treatment with Rebif versus an oral disease-modifying therapy, as well as the clinical effect of Rebif on 'no evident disease activity' (NEDA) and MRI outcomes, will be revealed in EMD Serono data.

"Patients with MS have more choices than ever before, but, given the potential devastation of this disease, consistent validation and balance of comparative effectiveness is paramount to selecting the most appropriate treatment," said Dr. Rick Munschauer, Vice President, Medical Affairs, Neurology and Immunology, EMD Serono. "We are committed to enhancing care for people living with MS. That commitment includes continuing to deepen our understanding of the clinical and real-world impact of Rebif to inform the most optimal choice of therapy for patients. With a well-established safety profile supported by more than 20 years of combined clinical trial and patient experience and efficacy across three key disease measures – including reducing relapse rates and delaying disability progression – Rebif is an important treatment option for relapsing MS."

The following abstracts have been accepted for presentation at the 68th AAN Annual Meeting:

Learn more about EMD Serono's programs, pipeline and activities in neurology by visiting our booth at this year's AAN Annual Meeting.

+ IMS NPA Market Dynamics Data, December 2015-February 2016 (rolling 3 months/New To Brand Rx). New To Brand Rx is defined as the sum of patients who are switching from another therapy (including patients who stopped a DMT for greater than 30 days, then restarted on a different DMT) as well as patients who have not received a prescription in at least the prior 12 months.

TECFIDERA^® (dimethyl fumarate) is a registered trademark of Biogen.

About Rebif® (interferon beta-1a)
Rebif (interferon beta-1a) is used to treat relapsing forms of MS to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS. The efficacy and safety of Rebif in controlled clinical trials beyond 2-years has not been established.

Important Safety Information
Rebif is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation.

Rebif should be used with caution in patients with depression, a condition that is common in people with multiple sclerosis. Depression, suicidal ideation, and suicide attempts have been reported to occur with increased frequency in patients receiving interferon compounds, including Rebif.

Severe liver injury, including some cases of hepatic failure requiring liver transplantation, has been reported rarely in patients taking Rebif. The potential for liver injury should be considered when used in combination with other products associated with liver injury.  Monitor liver function tests and patients for signs and symptoms of hepatic injury.  Consider discontinuing Rebif if hepatic injury occurs.

Anaphylaxis and other allergic reactions (some severe) have been reported as a rare complication of Rebif. Discontinue Rebif if anaphylaxis occurs.

In controlled clinical trials, injection site reactions occurred more frequently in Rebif-treated patients than in placebo-treated and Avonex-treated patients. Injection site reactions including injection site pain, erythema, edema, cellulitis, abscess, and necrosis have been reported in the postmarketing setting. Do not administer Rebif into affected area until fully healed; if multiple lesions occur, discontinue Rebif until skin lesions are healed.

Decreased peripheral blood counts in all cell lines, including pancytopenia, have been reported in Rebif-treated patients. In controlled clinical trials, leukopenia occurred at a higher frequency in Rebif-treated patients than in placebo and Avonex-treated patients. Thrombocytopenia and anemia occurred more frequently in 44 mcg Rebif-treated patients than in placebo-treated patients. Patients should be monitored for symptoms or signs of decreased blood counts. Monitoring of complete blood and differential white blood cell counts is also recommended.

Cases of thrombotic microangiopathy (TMA), some fatal, have been reported with interferon beta products, including Rebif, up to several weeks or years after starting therapy. Discontinue Rebif if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated.

Caution should be exercised when administering Rebif to patients with pre-existing seizure disorders. Seizures have been temporally associated with the use of beta interferons, including Rebif, in clinical trials and in postmarketing reports.

The most common side effects with Rebif are injection-site disorders, headaches, influenza-like symptoms, abdominal pain, depression, elevated liver enzymes, and hematologic abnormalities.

There are no adequate and well-controlled studies in pregnant women. Rebif should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Rebif full prescribing information is available at http://www.emdserono.com/ms.country.us/en/images/Rebif_PI_tcm115_140051.pdf?Version=

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.

About EMD Serono, Inc.
EMD Serono is the North America biopharma business of Merck KGaA, Darmstadt, Germany - a leading science and technology company - focused exclusively on specialty care. For more than 40 years, the business has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas. Today, the business has more than 1,100 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts.

www.emdserono.com

About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, 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 2014, Merck KGaA, Darmstadt, Germany, generated sales of € 11.3 billion in 66 countries.

Founded in 1668, Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck KGaA, Darmstadt, Germany, holds the global rights to the Merck KGaA, Darmstadt, Germany, 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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