GENEVA, June 17, 2010 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that data from the company's multiple sclerosis (MS) portfolio will be presented at the 20th Meeting of the European Neurological Society (ENS) taking place from June 19 to 23 in Berlin, Germany. The data presented will focus on Rebif(R) (interferon beta-1a), an established therapy for relapsing forms of MS, RebiSmart(TM), an electronic device for self-injection of Rebif(R) (currently not approved in the US), as well as Cladribine Tablets, an investigational oral therapy for relapsing-remitting MS currently under regulatory review in a number of countries.
Merck Serono has a long-term commitment to patients living with multiple sclerosis through the development of new therapeutic options, said Dr. Bernhard Kirschbaum, Merck Serono's Head of Global Research and Development. The data to be presented at the upcoming ENS meeting enhance our understanding of the clinical effects of Rebif(R) and Cladribine Tablets and underscore our commitment to advance multiple sclerosis research and to provide treatments that meet the individual needs of people living with multiple sclerosis.
The following abstracts have been accepted for presentation at the 20th ENS Meeting:
Rebif(R) (interferon beta-1a) / RebiSmart(TM)
- Evaluation of the risk of malignancy in patients with multiple sclerosis treated with subcutaneous interferon beta-1a (Presentation 044, Monday, June 21, 2010, 15:15-15:30 CET)
- Associations between annualized relapse rate and long-term exposure to subcutaneous interferon beta-1a in the Prevention of Relapses and disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis (PRISMS) long-term follow-up study (Poster P456, Tuesday, June 22, 2010, 11:30-13:00 CET) - Assessment of adherence to subcutaneous interferon beta-1a treatment in daily practice among patients with relapsing multiple sclerosis using an electronic self-injection device (Poster P580, Tuesday, June 22, 2010, 17:30-19:00 CET) Cladribine Tablets Platform presentation - Analysis of clinical and radiological disease activity-free status in patients with relapsing-remitting multiple sclerosis treated with cladribine tablets, in the double-blind, 96-week CLARITY study (Presentation O75, Monday, June 21, 16:00-16:15 CET) Poster presentations - Consistent efficacy of cladribine tablets across multiple sclerosis and patient characteristics, in the double-blind, 96-week CLARITY study (Poster P441, Tuesday, June 22, 11:30-13:00 CET - Reconstitution of circulating lymphocyte subsets after treatment with cladribine tablets in the 96-week CLARITY study in relapsing-remitting multiple sclerosis (Poster P442, Tuesday, June 22, 11:30-13:00 CET) - Late stage clinical development plan for cladribine tablets in the treatment of multiple sclerosis (Poster P443, Tuesday, June 22, 11:30-13:00 CET) - Evaluation of the long-term safety of cladribine tablets in multiple sclerosis: design of PREMIERE, a prospective, observational 8-year safety registry (P444, Tuesday, June 22, 11:30-13:00 CET)
Clinical aspects of MS
Physician and patient perspectives in multiple sclerosis: results from the MS Choices Survey (Poster P236, Monday, June 21, 2010, 11:30-13:00 CET)
Rebif(R) (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. The efficacy of Rebif(R) in chronic progressive MS has not been established. Interferons are thought to help modulate the body's immune system and reduce inflammation. The exact mechanism is unknown.
Rebif(R), which was approved in Europe in 1998 and in the US in 2002, is registered in more than 80 countries worldwide. Rebif(R) has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area*. Rebif(R) is available in a 22 micrograms and 44 micrograms ready-to-use pre-filled syringe and a titration pack (8.8 micrograms). Rebif(R) is now available in Germany, UK and Denmark as well as in Canada in two multidose cartridges [132 micrograms (three doses of 44 micrograms) and 66 micrograms (three doses of 22 micrograms)] for the use with the RebiSmart(TM) device.
Rebif(R) should be used with caution in patients with a history of depression, liver disease and seizures. 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(R) with their doctors.
* The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.
About Cladribine Tablets
Merck Serono's oral formulation of cladribine (Cladribine Tablets) is an investigational treatment for patients with relapsing-remitting multiple sclerosis (MS). Cladribine is a small molecule that may interfere with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are thought to be involved in the pathological process of MS. Merck Serono has applied for marketing approval of Cladribine Tablets in the European Union, the United States and other locations.
The clinical development program for Cladribine Tablets includes:
- The CLARITY (CLAdRIbine Tablets Treating MS OrallY) study and its extension: a two-year Phase III placebo-controlled trial designed to evaluate the efficacy and safety of Cladribine Tablets as a monotherapy in patients with relapsing-remitting MS and the CLARITY EXTENSION two-year Phase III study designed to provide data on the long-term safety and efficacy of extended administration of Cladribine Tablets for up to four years. - The ORACLE MS (ORAl CLadribine in Early MS) study: a two-year Phase III placebo-controlled trial designed to evaluate the efficacy and safety of Cladribine Tablets as a monotherapy in patients at risk of developing MS (patients who have experienced a first clinical event suggestive of MS). This trial was announced in September 2008. - The ONWARD (Oral Cladribine Added ON To Interferon beta-1a in Patients With Active Relapsing Disease) study: a Phase II placebo-controlled trial designed primarily to evaluate the safety and tolerability of adding Cladribine Tablets treatment to patients with relapsing forms of MS, who have experienced breakthrough disease while on established interferon-beta therapy. This trial was announced in January 2007.
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 people 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 division for innovative prescription pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. In the United States and Canada, EMD Serono operates through separately incorporated affiliates.
Merck Serono has leading brands serving patients with cancer (Erbitux(R), cetuximab), multiple sclerosis (Rebif(R), interferon beta-1a), infertility (Gonal-f(R), follitropin alfa), endocrine and metabolic disorders (Saizen(R) and Serostim(R), somatropin), (Kuvan(R), sapropterin dihydrochloride) as well as cardiometabolic diseases (Glucophage(R), metformin), (Concor(R), bisoprolol), (Euthyrox(R), levothyroxine). Not all products are available in all markets.
With an annual RD expenditure of more than EUR 1 billion, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.
Merck is a global pharmaceutical and chemical company with total revenues of EUR 7.7 billion in 2009, a history that began in 1668, and a future shaped by approximately 33,600 employees in 64 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.
SOURCE: Merck Serono S A
CONTACT: Merck Serono S.A. - Geneva, 9 Chemin des Mines, 1202 Genève,Suisse, Media relations, Tel: +41-22-414-36-00