SYS-CON MEDIA Authors: Yeshim Deniz, Elizabeth White, Sean Houghton, Glenn Rossman, Ignacio M. Llorente

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EMD Serono Presents New Data on Rebif® (interferon beta-1a) and Advancing MS Pipeline at AAN Annual Meeting

ROCKLAND, Mass., April 25, 2014 /PRNewswire/ -- EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, announced today that new data from the company's multiple sclerosis (MS) portfolio will be presented at the American Academy of Neurology's 66th Annual Meeting, taking place from April 26May 3, in Philadelphia, PA.

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Data from 14 study assessments presented by EMD Serono or its affiliate, Merck Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, will focus on Rebif® (interferon beta-1a), as well as three pipeline candidates:

  • Ceralifimod (ONO-4641) (S1P receptor agonist), an investigational oral compound being evaluated in a Phase II trial for relapsing-remitting MS.
  • ATX MS-1467, an investigational compound being evaluated in a Phase I trial for MS.
  • Plovamer Acetate (PI-2301), a second-generation peptide copolymer being evaluated in a Phase II clinical trial for MS. Plovamer Acetate is designed to bind to major histocompatibility complex (MHC) class II allelic variants associated with MS, with the aim of promoting regulatory effects in the immune system. 

"The data to be presented during the AAN meeting continue to advance our understanding of the important clinical effects of Rebif and demonstrate progress with our three pipeline candidates," said Thorsten Eickenhorst, Chief Medical Officer, EMD Serono. "Our company's scientific commitment to MS includes more than 20 years of clinical experience with Rebif and we continue to work to develop innovative treatment options and solutions for those living with MS."

The following abstracts have been accepted for presentation at the 66th AAN Annual Meeting:

Rebif (interferon beta-1a)

  • Relationship between Immunological Markers and Short-Term Brain Volume Changes in Patients with Relapsing-Remitting Multiple Sclerosis Receiving Interferon Beta-1a  (Poster P3.146 Session III;  Tuesday, April 29, 2014)
  • Correlations between Immunological Biomarkers and Conventional and Advanced MRI Measures Following Interferon Beta-1a Treatment for Relapsing-Remitting Multiple Sclerosis (Poster P3.147 Session III; Tuesday, April 29, 2014)
  • Early and Consistent Reduction in Relapses among Patients with Relapsing-Remitting Multiple Sclerosis Receiving Subcutaneous Interferon Beta-1a: A Post-Hoc Analysis of PRISMS Data (Poster P3.182 Session III; Tuesday, April 29, 2014)
  • Assessing a Scoring System to Predict Disease Activity in Patients with Multiple Sclerosis: Post Hoc Analyses of Data from Clinical Trials of Subcutaneous Interferon Beta-1a (Poster P3.178 Session III; Tuesday, April 29, 2014)
  • Changes in Immunological Biomarkers in Patients with Relapsing–Remitting Multiple Sclerosis Treated with Interferon Beta-1a (Poster P4.132 Session IV; Wednesday, April 30, 2014)
  • Associations Between Changes in Ferritin Levels and  Susceptibility-Weighted Imaging Filtered Phase in Patients with Relapsing-Remitting Multiple Sclerosis over Six Months Therapy with Interferon Beta-1a   (Poster P6.115, Session VI; Thursday, May 1, 2014)
  • Subcutaneous Interferon Beta-1a Decreases the Evolution of Gadolinium-Enhancing Lesions Into Chronic Black Holes in Relapsing Multiple Sclerosis (P7.240, Session VII; Thursday, May 1, 2014)
  • Adherence to, and Effectiveness of, Treatment with Subcutaneous Interferon Beta-1a in Relapsing Multiple Sclerosis Patients using RebiSmart™ for Self-Injection: Final Results of the One-Year International, Observational SMART Study (P7.219, Session VII; Thursday, May 1, 2014) 

Ceralifimod (ONO-4641)

  • Ceralifimod (ONO-4641) Reduces MRI Lesions and Prevents Disease Progression in an Animal Model of Multiple Sclerosis (P1.219, Session I; Monday, April 28, 2014)
  • Ceralifimod (ONO-4641) Prevents Evoked Potential Deficits in an Animal Model of Multiple Sclerosis (P1.218, Session I; Monday, April 28, 2014)
  • Effect of Ceralifimod (ONO-4641), a Sphingosine-1-Phosphate Receptor-1 and -5 Agonist, on Magnetic Resonance Imaging Outcomes in Patients with Multiple Sclerosis: Interim Results from the Extension of the DreaMS Study (P3.161, Session III; Tuesday, April 29, 2014)

ATX-MS-1467

  • ATX-MS-1467, An Immunotolerizing Agent, Halts Disease Progression and Reduces CNS Inflammation in Rodent Models of Multiple Sclerosis  (P1.216, Session I, Monday, April 28, 2014)
  • Preclinical Efficacy and Phase I Clinical Testing of ATX-MS1467, an Antigen-Specific Immunotherapy for Multiple Sclerosis (P1.189, Session I; Monday, April 28, 2014)        

Plovamer Acetate (PI-2301)

  • Differentiating Plovamer Acetate and Glatiramer Acetate: Efficacy and Mechanism of Action in a Preclinical Model of Multiple Sclerosis (P1.187, Session I; Monday, April 28, 2014)

EMD Serono is engaged in strategic research collaborations funding promising neurology research with leading academic and healthcare institutions. Learn more about EMD Serono's programs, pipeline and activities in neurology by visiting booths #1133 and #1332 at this year's AAN Annual Meeting.

About Rebif® (interferon beta-1a)

Rebif 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. Rebif is not approved for treatment of chronic progressive MS. Rebif is available in 22 mcg and 44 mcg prefilled, preassembled syringes and a titration pack.

Rebif will not cure MS but it has been shown to decrease the number of flare-ups and slow the occurrence of some of the physical disability that is common in people with MS. Rebif can cause serious side effects, so before taking Rebif, patients should talk with their doctor about the possible benefits of Rebif and its possible side effects.

Potential serious side effects of Rebif include depression, liver problems, risk to pregnancy, allergic reactions and injection-site problems. Patients who have had an allergic reaction such as difficulty breathing, flushing or hives to another interferon beta or to human albumin should not take Rebif.

Before taking Rebif (interferon beta-1a), patients should tell their doctor if they have a history of depression, anxiety, trouble sleeping, liver disease, thyroid problems, blood cell count or bleeding problems, epilepsy, or are planning to become pregnant. Patients should tell their doctor about all medicines they take, including prescription and non-prescription medicines, vitamins and herbal supplements. Rebif and other medicines may affect each other causing serious side effects. Patients should talk to their doctor before taking any new medicines.

Possible side effects of Rebif include flu-like symptoms (fever, chills, sweating, muscle aches and tiredness), injection-site reactions, depression and anxiety, liver problems, abdominal pain, blood problems, thyroid problems and severe allergic reactions. Patients should let their doctor know if they have any of these symptoms or feel sad, tired, hot or cold, or experience hives, rashes, bruising, yellowing of the skin, or a change in body weight (gain or loss).

This information is not intended to replace discussions with a doctor. For additional information about Rebif, please consult the Prescribing Information and Medication Guide at www.rebif.com and talk to a health care professional. Information is also available at www.mslifelines.com or call toll-free 1-877-44-REBIF (1-877-447-3243). Rebif is available by prescription only.

About EMD Serono, Inc.

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, is a specialized biopharmaceutical company dedicated to developing therapies with groundbreaking potential. The company has strong market positions in neurology, endocrinology and in reproductive health. In addition, EMD Serono has an enduring commitment to solve the unsolvable, with state-of-the-art science dedicated to developing new therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology. With a long-standing history of industry expertise and a dedication to shape the future of healthcare, the company's US footprint continues to grow, with approximately 1,000 employees around the country and fully integrated commercial, clinical and research operations 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 the pharmaceutical and chemical sectors. Its subsidiaries in Canada and the United States operate under the umbrella brand EMD. Around 38,000 employees work in 66 countries to improve the quality of life for patients, to further the success of customers and to help meet global challenges. The company generated total revenues of €11.1 billion in 2013 with its four divisions: Biopharmaceuticals, Consumer Health, Performance Materials and Life Science Tools. Merck KGaA of Darmstadt, Germany is the world's oldest pharmaceutical and chemical company – since 1668, the name has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day.

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