Merck Serono expands availability of its RebiSmart device and web-based software platform MSdialog to people with MS in Spain, Greece, Hungary, Israel, Chile and Colombia

• The new RebiSmart® injection device offers many new updates including wireless transmission of injection times and doses
• MSdialog™software is designed to more effectively engage people with MS and their health care providers with treatment adherence information and health related outcome reports
• The New RebiSmart® and MSdialog™ are now available in 20 countries

Darmstadt, Germany, 17-11-2014 — /EuropaWire/ — Merck Serono, the biopharmaceutical division of Merck, announced the expanded launch of its updated electronic injection device, the new RebiSmart®, for the self-administration of Rebif® (interferon beta-1a), the company’s disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS), along with its new first-of-its-kind web-based software platform, MSdialog™.

Following an initial launch in 14 countries in May, MSdialog and the new RebiSmart device are now also available to people with MS and their healthcare team in Spain, Greece, Hungary, Israel, Chile and Colombia.

People with MS can self-inject Rebif with the new RebiSmart, place the device in its transmitter and wirelessly send treatment data – injection times and doses – to the secure MSdialog server, where it is stored and available to be reviewed by people with MS and their health care providers. People with MS who use MSdialog can choose to receive email or SMS reminders to take their medication, and, along with their nurses, use MSdialog in between visits with their physician to track adherence and report health related outcomes.

MSdialog also allows people with MS to engage in the management of their disease by asking them to complete periodic health report questionnaires based on short forms of published instruments and standard scales, such as the Multiple Sclerosis Quality of Life Inventory (MSQLI) and the Multiple Sclerosis International Quality of Life (MusiQoL) questionnaires.

“People with MS often cite a lack of adequate technology tools to help them effectively engage with their healthcare team in between and during consultations, and in my own practice, I’ve seen firsthand the need for tools to help capture important information that could influence care decisions,” said Dr. Peter Rieckmann, Head of the Neurology Department at Bamberg Academic Hospital at the University of Erlangen in Germany. “The launch of MSdialog along with the new RebiSmart can address these key unmet needs by allowing people with MS to easily and securely share not only their adherence information, but also how they feel by answering simple health questionnaires such as the validated MusiQoL, thus leading to more effective consultations and the opportunity to deliver the drug treatment more reliably.”

“With the introduction of MSdialog, we are offering a unique digital technology to provide people with MS a management system that can help them create a more open dialogue with their healthcare team,” said Dr. Steven Hildemann, Chief Medical Officer, and Head of Global Medical Affairs and Global Drug Safety at Merck Serono. “Following a successful launch in May, we are thrilled to offer this new management solution in additional countries and look forward to receiving regulatory approval in more countries in the near future.”

RebiSmart was the first injection device in MS that records the date, time and dosage of each injection so that an accurate dosing history can be discussed with a patient, allowing physicians to monitor and improve patient adherence to therapy. The new RebiSmart offers updates to the original device, including a larger screen, new interactive on-screen guide and signals to help patients through the injection process, graphical display of treatment adherence and a transmitter for wireless data transfer. The new RebiSmart is used with Rebif multidose cartridges, each of which contains one week’s worth of medicine. Individually adjustable comfort settings give patients more flexibility with injection duration, speed and depth, helping minimize discomfort and pain.

The new RebiSmart and MSdialog were first available in the United Kingdom, France, Italy, Switzerland, Ireland, Austria, Finland, Portugal, Germany, Belgium, Canada, Denmark, Luxembourg, Netherlands and Sweden as of May 2014, and further launches will follow in 2015. Two strengths of the multidose cartridge—132 µg (three doses of 44 µg) and 66 µg (three doses of 22 µg)—were approved by the European Medicines Agency (EMA) in January 2009.

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. Interferon ß is thought to help 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 can be administrated with the RebiSmart electronic auto-injection device, or with the RebiDose single-use disposable pen, or the manual multidose injection pen RebiSlide. Rebif can also be administered with the autoinjector Rebiject II or by manual injection using ready-to-use pre-filled syringes. These injection devices are not available in all countries.

In January 2012, the European commission approved the extension of the indication of Rebif in early multiple sclerosis. The extension of the indication of Rebif has not been submitted in the United States.

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.

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. 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 separately incorporated subsidiary of Merck Serono.
Merck Serono 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.

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Merck 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 generated total revenues of € 11.1 billion in 2013. Around 39,000 Merck 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 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, Darmstadt, Germany is holding 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.

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

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