Merck KGaA to Introduce RebiDose, the Rebif Single Use Pre-filled Pen for Treatment of Multiple Sclerosis

Merck KGaAMerck KGaA announced the upcoming introduction of the new device RebiDose, the Rebif single use pre-filled pen, for the self-administration of Rebif (interferon beta-1a), a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS).

"We are pleased to extend our range of devices with RebiDose to meet the needs of patients looking for simple and minimum injection preparation," said Roberto Gradnik, Head of Global Business Unit Neurodegenerative Diseases at the Merck Serono division. "The introduction of RebiDose, alongside RebiSmart, which was launched last year, underscores our commitment to improve the treatment convenience of multiple sclerosis patients, by offering them different options to suit their individual injection needs."

RebiDose was specifically designed to provide MS patients with a quick and simple device. This pre-filled injection device may also be ideal for patients who are traveling. RebiDose used with Rebif will be available in a monthly pack in two different doses (22 micrograms and 44 micrograms) and in a titration pack including two different doses (8.8 micrograms and 22 micrograms). RebiDose has been approved in the European Union and in Australia. It will be launched on a country-by-country basis, with first launches planned by the end of the year.

The results of the RebiDose user trial showed that the majority of subjects found the device easy to use, reliable and convenient with a 0.4% error rate. 72% percent of study participants indicated that they would continue using RebiDose if it became available. The RebiDose user trial data were presented today at the 26th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS) held in Gothenburg, Sweden, from October 13-16, 2010.

RebiDose user trial
The user trial was a 12-week, phase IIIb, multicenter, open-label, single-arm study to evaluate RebiDose, for the self administration of Rebif (interferon beta-1a) with respect to ease of use, patient satisfaction and acceptability, and functional reliability. Patients with relapsing MS, who were receiving Rebif 44 microgram three times weekly for more than 12 weeks, continued MS therapy using RebiDose for 12 weeks.

A total of 109 patients were enrolled in the study. Patients were between 18 and 65 years old with relapsing MS (McDonald criteria) and had received Rebif, 44 microgram three times weekly, consistently for 12 weeks or more prior to screening. Patients completed a user trial questionnaire at baseline and weeks 6 and 12.

The primary endpoint was the proportion of patients rating RebiDose as "easy" or "very easy to use" at week 12. Secondary endpoints included ratings of functional reliability, simplicity of use, and convenience. QoL was assessed using the Short Form-36v2 General Health Survey at screening and week 12. Safety endpoints included the incidence of serious adverse events (AEs).

RebiDose has not been approved in the U.S.

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. The efficacy of Rebif 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, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 90 countries worldwide. Rebif has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area*. Rebif is available in a 22 micrograms and 44 micrograms ready-to-use pre-filled syringe and a titration pack (8.8 micrograms). Rebif is also now available 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 device, in several EU member countries, Switzerland and Canada, as well as in Australia.

Rebif 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 with their doctors.

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

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 KGaA
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 40,000 employees (including Merck Millipore) 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.

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