EMD Serono Presents New Data on Rebif ® (Interferon beta-1a) and Multiple Sclerosis Pipeline at Joint ACTRIMS-ECTRIMS Meeting in Boston

• Data include post-hoc assessments of controlled studies in relapsing MS regarding evolution of gadolinium-enhancing lesions, assessments of predictive scores for disease activity and disability progression, and 'no evident disease activity' (NEDA) measure for interferon beta-1a SC vs. interferon beta-1a IM

• Data presented on pipeline compounds underscore company's commitment to scientific advancements in MS
  

MISSISSAUGA, ON, Sept. 10, 2014 /CNW/ - EMD Serono, Canada, a subsidiary of Merck KGaA Darmstadt, Germany, together with its U.S. subsidary, announced today that new data from the division's multiple sclerosis (MS) portfolio will be presented at ACTRIMS-ECTRIMS 2014, the joint meeting of the Americas Committee for Treatment and Research in MS (ACTRIMS) and European Committee for Treatment and Research in MS (ECTRIMS), taking place September 10-13 in Boston, U.S.A.

Data from 12 study assessments supported 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 two investigational compounds:

• ATX MS-1467, an investigational compound being evaluated in a Phase I clinical trial for MS.
• Plovamer Acetate (PI-2301), an investigational compound being evaluated in a Phase II clinical trial for MS.

Additionally, Merck KGaA, Darmstadt, Germany will announce the second annual recipients of the Grant for Multiple Sclerosis Innovation (GMSI) Awards at a satellite symposium on Friday, September 12 from 7:00 – 8:00 a.m. ET (Room 312, Level 3). The grant recipients will share up to €1 million to support their promising translational research projects, with the aim of improving understanding of MS for the ultimate benefit of people living with the disease.

"The research presented at the joint ACTRIMS-ECTRIMS meeting reinforces EMD Serono's commitment to addressing the unmet needs of people living with MS," said Steven Hildemann, Senior Vice President, Chief Medical Officer, and head of Global Medical Affairs and Global Drug Safety at Merck Serono.  "We continue to advance our understanding of the clinical effects of Rebif and demonstrate progress with our pipeline candidates, with the ultimate goal of developing innovative solutions and therapies for the MS community."

The following abstracts have been accepted for presentation at ACTRIMS-ECTRIMS 2014:

Rebif® (interferon beta-1a) and Multiple Sclerosis

• No evident disease activity at 24 weeks in patients with relapsing MS treated with interferon beta-1a SC vs. interferon beta-1a IM in the EVIDENCE study (Poster P102, Clinical Trials; Thursday, September 11, 3:30 – 5:00 p.m. ET)
• No evident disease activity in relapsing MS patients treated with interferon beta-1a SC vs. interferon beta-1a IM: subgroup analyses of the EVIDENCE study (Poster P104, Clinical Trials; Thursday, September 11, 3:30 – 5:00 p.m. ET)
• Challenges experienced by neurologists in the individualization of multiple sclerosis treatment: findings from an international study (Poster P321, Disease Therapy; Thursday, September 11, 3:30 – 5:00 p.m. ET)
• Multiple sclerosis treatment practices in women of child-bearing age in Switzerland: results of the women with MS online survey (Poster P325, Disease Therapy; Thursday, September 11, 3:30 – 5:00 p.m. ET) 
• Evolution of gadolinium-enhancing lesions into chronic black holes in patients treated with subcutaneous interferon beta-1a in PRISMS and SPECTRIMS (Poster P470, Imaging-1; Thursday, September 11, 3:30 – 5:00 p.m. ET)
• Natural evolution of gadolinium-enhancing lesions into chronic black holes in multiple sclerosis: analysis of PRISMS and SPECTRIMS placebo arms (Poster P473, Imaging-1; Thursday, September 11, 3:30 – 5:00 p.m. ET)
• Assessing a predictive score for disease activity in secondary progressive multiple sclerosis: post-hoc analysis of data from the SPECTRIMS study (Poster P766, Prognostic Factors; Friday, September 12, 2:45 – 4:15 p.m. ET )
• Assessing a predictive score for long-term disability progression in relapsing-remitting multiple sclerosis: 7/8-year follow-up in the PRISMS study (Poster P765, Prognostic Factors; Friday, September 12, 2:45 – 4:15 p.m. ET)
• Cognition and fatigue in patients with relapsing multiple sclerosis treated by subcutaneous interferon beta-1a: an observational study SKORE (Poster P780, PROs and QoL; Friday, September 12, 2:45 – 4:15 p.m. ET)
• A prospective study comparing the impact of three levels of support services on interferon beta adherence in patients with relapsing MS: interim results (Poster P828, Rehabilitation and Comprehensive Care; Friday, September 12, 2:45 – 4:15 p.m. ET)
• ATX-MS-1467 reduces MRI lesions and prevents disease progression in a humanized mouse model of multiple sclerosis (Poster P378, Experimental Models; Thursday, September 11, 3:30 – 5:00 p.m. ET) 

Plovamer Acetate (PI-2301)

• Plovamer acetate causes a more pronounced increase in eosinophils and CCL22 in naive and EAE mice compared with glatiramer acetate (Poster P398, Experimental Models; Thursday, September 11, 3:30 – 5:00 p.m. ET) 
  The clinical candidates above are currently under clinical investigation and have not been approved for use in the United States, Europe, Canada or elsewhere. The clinical candidates have not been proven to be safe or effective, and any claims of safety and effectiveness can be made only after regulatory review of the data and approval of the labeled claims.

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 has not yet been investigated in patients with primary progressive multiple sclerosis. In Canada, Rebif is indicated for:

• The treatment of relapsing forms of multiple sclerosis (MS), to
  • reduce the number and severity of clinical exacerbations,
  • slow the progression of physical disability,
  • reduce the requirement for steroids,
  • reduce the number of hospitalizations for treatment of multiple sclerosis, and
  • reduce T1-Gd enhanced and T2 (burden of disease) lesions as seen on MRI.
• The treatment of patients who have experienced a single demyelinating event, accompanied by an active inflammatory process and an abnormal MRI scan with lesionstypical of MS, who are determined to be at high risk of developing clinically definite multiple sclerosis.

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).

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 Merck Serono
Merck Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separate subsidiary of Merck KGaA, Darmstadt, Germany.

Merck Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology.

For more information, please visit www.merckserono.com

Merck KGaA, Darmstadt, Germany. is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. With its four divisions Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck KGaA, Darmstadt, Germany, generated total revenues of € 11.1 billion in 2013. Around 39,000 Merck KGaA, Darmstadt, Germany.  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. 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 percent 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 is known as EMD.

About EMD Serono, Canada
EMD Serono is a Division of EMD Inc., Canada, a subsidiary of Merck KGaA, Darmstadt, Germany. In Canada, EMD Serono provides innovative drug therapies that address unmet medical needs in the areas of neurodegenerative diseases, fertility and endocrinology. EMD Serono employs approximately 150 people across Canada and is headquartered in Mississauga, Ontario. For more information, please visit to www.emdserono.ca.

SOURCE: EMD Inc.

Shikha Virdi, 905-919-0200 ext. 5504