Friday, October 12, 2007

Interferon Beta-1a Offers A Near 3-fold Improvement In Injection Tolerability Compared With The Original Formulation - 2-Year Phase IIIb Data

Merck Serono, a division of Merck KGaA, announced today new results of a two year (96 week) Phase IIIb study in 260 patients which has shown that the new formulation of Rebif® (interferon beta-1a) offers a near three-fold improvement in injection tolerability for patients with relapsing remitting multiple sclerosis (RRMS). These results are compared with historical data for the previous formulation of Rebif® (30.8% versus 85.8%) (1).

These study results will be presented today at a satellite symposium and tomorrow at a poster session at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Prague, Czech Republic.

"Rebif is an established first-line disease modifying treatment for relapsing types of MS" said Professor Gavin Giovannoni from The Royal London Hospital. "Injection site reactions can lead to withdrawal from treatment. The reduction in these reactions with the new formulation should improve treatment benefit to patients."

Rebif® has a favourable benefit-to-risk profile (2) and has a proven efficacy and safety profile, which has been demonstrated consistently across numerous phase III clinical trials and clinical practice (1, 3-5). The new study results have also confirmed consistent efficacy of the new formulation of Rebif® compared with previous experience (1). At 96 weeks, 53.3% of patients remained relapse-free and overall the expanded disability status scale (EDSS) score remained stable throughout the study.

The new formulation of Rebif® was approved on August 10, 2007, by the European Commission and is due to be launched in the UK in early 2008. The new formulation of Rebif® is the first and only therapy for multiple sclerosis that is serum free, both from animal and human-derived components (HSA-free and FBS-free) and is the latest product development from Merck Serono. Other recent enhancements have included the launch of a new initiation pack designed to make starting Rebif® therapy easier and more convenient.


1. Panitch H, Goodin DS, Francis G, Chang P, Coyle PK, O'Connor P, et al. Randomized, comparative study of interferon beta-1a treatment regimens in MS: the EVIDENCE trial. Neurology 2002; 59: 1496-506.
2. Francis GS. Importance of benefit-to-risk assessment for disease-modifying drugs used to treat MS. J Neurol 2004; 251 (Suppl 5): v42-9.
3. Li D, Paty D, UBC MS/MRI Analysis Research Group, PRISMS Study Group. Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebo controlled study of interferon-b1a in relapsing-remintting multiple sclerosis. Ann Neurol 1999; 46: 197-206
4. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcultaneously in Multiple Sclerosis) Study Group. Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. Lancet 1998; 352: 1498-504, Erratum inLancet 1999; 353; 678.
5. PRISMS Study Group, University of British Columbia MS/MRI Analysis Group. PRISMS-4: Long-term efficacy of interferon-β-1a in relapsing MS. Neurology 2001; 56: 1628-36.

About the Study

The study was a two-year (96 weeks) Phase IIIb, international, multicenter, single-arm, open-label study with historical controls, evaluating the safety and immunogenicity of the new formulation of Rebif® (interferon beta-1a) 44 micrograms (mcg) subcutaneously (sc) three times weekly (tiw) in 260 patients with relapsing forms of multiple sclerosis (MS).

No unexpected adverse events were reported with the new formulation of Rebif®. Safety outcomes were consistent with the known profile of Rebif®. The majority of adverse events were mild or moderate in severity. The most frequent side effect was flu-like symptoms (71.5%), which is typical of interferon therapy; most were mild in severity. Flu-like symptoms are transient. Prophylactic antipyretic treatment is recommended.

About Rebif®

Rebif® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. Interferon helps modulate the body's immune system and reduce inflammation.

Rebif®, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 80 countries worldwide. Rebif® has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity compared to placebo*. Rebif® is not approved for treatment of chronic progressive MS. Rebif® is available in a 22 mcg and 44 mcg ready-to-use pre-filled syringe and a titration pack (8.8 mcg and 22mcg).

Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif® with their doctors.

* The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.

About Merck Serono and Multiple Sclerosis

Merck Serono is a leader in multiple sclerosis (MS) with Rebif® (interferon beta-1a), a disease-modifying drug used to treat relapsing forms of MS, which is registered in more than 80 countries worldwide. In addition to Rebif®, the Company also offers a second therapy within its US portfolio of MS therapies: Novantrone® (mitoxantrone for injection concentrate). Product information can be obtained by contacting the Company or visiting its website. Additional therapeutic options are currently under development at Merck Serono, including cladribine, currently in Phase III, as well as several products in early stage development. Merck Serono also is taking a leading role in developing an understanding of the role of genetics in MS.

About Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, neurological disease in young adults. The World Health Organization estimates that up to 2.5 million people suffer from 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, the new division for innovative small molecules and biopharmaceuticals of Merck was established following the acquisition of Serono and the integration of its business with the former Merck Ethicals Division. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, produces and commercializes innovative products to help patients with diseases with unmet needs. Our North American business operates in the United States and Canada under EMD Serono.

Merck Serono has leading brands serving patients with cancer, metabolic and cardiometabolic disorders, as well as psoriasis. With an annual R&D investment of EUR 1bn, we are committed to growing our business in specialist-focused therapeutic areas such as Neurology and Oncology, as well as new therapeutic areas potentially arising out of our research and development in autoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by 35,091 employees in 62 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.