Rebif® (interferon beta-1a) Data at CMSC Annual Meeting Highlights Clinical and MRI Predictors for Long Term Outcomes

ROCKLAND, Mass., May 21, 2015 /PRNewswire/ -- EMD Serono, Inc., the U.S. biopharmaceuticals business of Merck KGaA, Darmstadt, Germany, announced today that data about Rebif® (interferon beta-1a), the company's high-dose, high-frequency interferon beta for relapsing forms of multiple sclerosis, will be presented at the 2015 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC), taking place from May 27-30 in Indianapolis, Indiana.

Data from 11 abstracts to be presented assess the efficacy of Rebif (interferon beta-1a) on MRI and clinical outcomes, and evaluate early predictors of no evidence of disease activity (NEDA) response, among other measures. The data also explores real-world evidence in MS, with analysis of time to first treatment with disease modifying drug as well as trends in treatment adherence among patients treated with self-injectables versus oral therapies.

"EMD Serono continues to evaluate the patient outcomes of Rebif, more specifically the important role it plays in the lives of those living with MS," said Dr. Rick Munschauer, Vice President, Medical Affairs, Neurology and Immunology, EMD Serono. "Our scientific and medical presence at this year's CMSC Annual Meeting is aimed at enhancing the understanding of our product and its effect on key measures in MS to help optimize patient care."

In addition to Rebif, EMD Serono is engaged in strategic research collaborations funding promising neurology research with leading academic and healthcare institutions. The company also has ongoing MS clinical study programs, including a Phase I study of ATX-MS-1467, an investigational therapy for relapsing remitting multiple sclerosis (RRMS), and a Phase IIb study of imilecleucel-T, an investigational therapy for Secondary Progressive MS (SPMS), an area of high unmet medical need. The company has an option agreement with Opexa Therapeutics, Inc. for the development and commercial licensing of imilecleucel-T.

The following abstracts have been accepted for presentation at the 2015 Annual Meeting of the CMSC:

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.

Important Safety Information
Before beginning treatment, you should discuss the potential benefits and risks associated with Rebif with your healthcare provider.

Rebif can cause serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while taking Rebif.

• Behavioral health problems including depression and suicidal thoughts. You may have mood problems including depression (feeling hopeless or feeling bad about yourself), and thoughts of hurting yourself or suicide
• Liver problems or worsening of liver problems including liver failure. Symptoms may include nausea, loss of appetite, tiredness, dark colored urine and pale stools, yellowing of your skin or the white part of your eye, bleeding more easily than normal, confusion, and sleepiness. During your treatment with Rebif you will need to see your healthcare provider regularly and have regular blood tests to check for side effects
• Serious allergic and skin reactions. Symptoms may include itching, swelling of your face, eyes, lips, tongue or throat, trouble breathing, anxiousness, feeling faint, skin rash, hives, sores in your mouth, or skin blisters and peels
• Injection site problems. Symptoms at the injection site may include redness, pain, swelling, color changes (blue or black), and drainage of fluid.
• Blood problems. Rebif can affect your bone marrow and cause low red and white blood cell, and platelet counts. In some people, these blood cell counts may fall to dangerously low levels. If your blood cell counts become very low, you can get infections and problems with bleeding and bruising. Your healthcare provider may ask you to have regular blood tests to check for blood problems
• Seizures. Some people have had seizures while taking Rebif

Rebif will not cure your MS but may decrease the number of flare-ups of the disease and slow the occurrence of some of the physical disability that is common in people with MS.
Do not take Rebif if you are allergic to interferon beta, human albumin, or any of the ingredients in Rebif.

Before you take Rebif, tell your healthcare provider if you have or have had any of the following conditions:

• mental illness, including depression and suicidal behavior
• liver problems, bleeding problems or blood clots, low blood cell counts, seizures (epilepsy), or thyroid problems
• drink alcohol
• you are pregnant or plan to become pregnant. It is not known if Rebif will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with Rebif.
• you are breastfeeding or plan to breastfeed. It is not known if Rebif passes into your breast milk. You and your healthcare provider should decide if you will use Rebif or breastfeed. You should not do both.

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

The most common side effects of Rebif include:

• flu-like symptoms. You may have flu-like symptoms when you first start taking Rebif. You may be able to manage these flu-like symptoms by taking over-the-counter pain and fever reducers. For many people, these symptoms lessen or go away over time. Symptoms may include muscle aches, fever, tiredness, and chills
• stomach pain
• change in liver blood tests

For additional information about Rebif, please consult the Prescribing Information and Medication Guide at www.rebif.com and talk to a health care professional.

About EMD Serono
EMD Serono, a subsidiary of Merck KGaA, Darmstadt, Germany, is a leading US biopharmceutical company focused exclusively on specialty care. For more than 40 years, EMD Serono has integrated cutting-edge science, innovative products and devices, 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 neurology, oncology, immunology and immuno-oncology. Today, EMD Serono has more than 1,100 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts.

For more information, please visit www.emdserono.com

About Merck KGaA, Darmstadt, Germany
Merck KGaA of Darmstadt, Germany, is a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials. The company has six businesses – Biopharmaceuticals, Consumer Health, Allergopharma, Biosimilars, Life Science and Performance Materials – and generated sales of € 11.3 billion in 2014. Around 39,000 employees work in 66 countries to improve the quality of life for patients, to foster the success of customers and to help meet global challenges. Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70% interest, the founding family remains the majority owner of the company to this day. Merck KGaA, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company operates as EMD Serono, EMD Millipore and EMD Performance Materials.

Erin Marie Beals
Phone 781-681-2850
[email protected]

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SOURCE EMD Serono

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