EMD Serono announces publication of PRISMS-15 yr follow-up study in patients using Rebif® (interferon beta-1a), focused on factors influencing outcomes in RRMS

ROCKLAND, Mass., Oct. 12, 2015 /PRNewswire/ -- EMD Serono, the U.S. biopharmaceutical business of Merck KGaA, Darmstadt, Germany, today announced that the Journal of Neurology, Neurosurgery and Psychiatry (JNNP) published 15 year follow-up data for Rebif® (interferon beta-1a), the company's high-dose, high-frequency interferon beta for relapsing forms of multiple sclerosis from PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) trial. The published data highlights outcomes from an exploratory study of the relationship between cumulative exposure to subcutaneous (sc) interferon (IFN) beta-1a treatment and other possible prognostic factors with clinical outcomes in relapsing–remitting multiple sclerosis (RRMS).

"The publication of the PRISMS-15 study in JNNP offers the MS medical community a retrospective single visit assessment in a subset of RRMS patients from the PRISMS trial with varying exposure to Rebif," said Dr. Rick Munschauer, Vice President, Medical Affairs, Neurology and Immunology, EMD Serono.

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.

Kappos L, et al. J Neurol Neurosurg Psychiatry 2015;0:1–6. doi:10.1136/jnnp-2014-310024

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
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, the U.S. biopharmaceutical business of Merck KGaA, Darmstadt, Germany, is a leading U.S. biopharma 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.

Merck KGaA, Darmstadt, Germany
Merck KGaA, 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

SOURCE EMD Serono