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Merck Serono Launches RebiSmart(TM), First Electronic Injection Device for Delivery of Multiple Sclerosis Treatment Rebif(R)
RebiSmart(TM) is Designed to Improve Ease of Handling and Usage andIntroduces the Potential for Improved Treatment Adherence for MultipleSclerosis Patients.
CJ: PR Agencies
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GENEVA, June 24 /PRNewswire/ --

- First Launch of RebiSmart(TM) Together With Recently Approved MultidoseCartridges of the new Formulation of Rebif(R) in the European Union andCanada

Merck Serono, a division of Merck KGaA, Darmstadt, Germany,announced today the launch of the innovative individually adjustableelectronic injection device RebiSmart(TM) for the self-administration ofRebif(R) (interferon beta-1a), the company's disease-modifying drug used totreat relapsing forms of multiple sclerosis (MS). RebiSmart(TM) is the firstdevice of its kind in this indication and was specifically designed for easeof handling and use. The unique features of RebiSmart(TM) also introduce thepotential for improved treatment adherence, helping patients receive the fullbenefit from their treatment.

RebiSmart(TM) is used with Rebif(R) multidose cartridges, eachof which contains one week's worth of medicine. Interactive, on-screeninstructions and signals guide patients through the injection process,individually adjustable comfort settings give patients more flexibility withinjection duration and depth, helping minimize discomfort and pain.

"Making injection more comfortable for the patient isimportant to ensure optimal treatment outcomes in multiple sclerosis," saidDr. Virginia Devonshire, Assistant Professor of Neurology at the Universityof British Columbia in Vancouver, Canada. "The first electronic injectiondevice in MS is an innovative approach and could contribute to increasingpatient adherence to therapy."

RebiSmart(TM) is the first and only injection device in MSthat records the date, time and dosage of each injection so that an accuratehistory of dosing can be viewed and discussed with the patient, allowingphysicians to monitor and improve patient adherence to therapy. The dosehistory can be downloaded and viewed on a personal computer, thus alsoenabling the upload to patient registries in order to evaluate outcomes datain MS.

"The introduction of RebiSmart(TM) underscores our commitmentto continuous advancements in multiple sclerosis treatments, in this caseproviding patients with an easy-to-use and innovative delivery system," saidDr. Roberto Gradnik, Executive Vice President Commercial Europe at MerckSerono. "Patients and healthcare professionals were involved in the design ofRebiSmart(TM), and their feedback was extremely valuable for developing aninnovative device that really meets their needs."

RebiSmart(TM) has been approved in Canada and the EuropeanUnion. It was first launched in the United Kingdom and is also available inCanada now. Further launches will follow on a country-by-country basis. Twostrengths of the multidose cartridge, 132 micrograms (three doses of 44micrograms) and 66 micrograms (three doses of 22 micrograms), were approvedby the European Medicines Agency (EMEA) in January 2009. RebiSmart(TM) alsofacilitates use by patients starting treatment through its automaticpre-programmed titration setting. In May 2009, the Committee for MedicinalProducts for Human Use (CHMP), the scientific committee of the EMEA, issued apositive opinion for the storage of the multidose cartridge at temperaturesup to 25 degreesC for 2 weeks.

For more information, please visit http://www.rebismart.com

About Rebif(R)

Rebif(R) (interferon beta-1a) is a disease-modifying drug usedto treat relapsing forms of multiple sclerosis (MS) and is similar to theinterferon beta protein produced by the human body. The efficacy of Rebif(R)in chronic progressive MS has not been established. Interferons are thoughtto help modulate the body's immune system and reduce inflammation. The exactmechanism is unknown.

Rebif(R), which was approved in Europe in 1998 and in the USin 2002, is registered in more than 80 countries worldwide. Rebif(R) has beenproven to delay the progression of disability, reduce the frequency ofrelapses and reduce MRI lesion activity and area*. Rebif(R) is available in a22 micrograms and 44 micrograms ready-to-use pre-filled syringe and atitration pack (8.8 micrograms).

Rebif(R) should be used with caution in patients with a history ofdepression, liver disease and seizures. Most commonly reported side effectsare flu-like symptoms, injection site disorders, elevation of liver enzymesand blood cell abnormalities. Patients, especially those with depression,seizure disorders, or liver problems, should discuss treatment with Rebif(R)with their doctors. For more information about Rebif(R), please visithttp://www.mslifelines.com for prescribing information.

* The exact correlation between MRI findings and the currentor future clinical status of patients, including disability progression, isunknown.

About Merck Serono and multiple sclerosis

Merck Serono is a leader in multiple sclerosis (MS) withRebif(R) (interferon beta-1a), a disease-modifying drug used to treatrelapsing forms of MS, which is registered in more than 80 countriesworldwide. Full prescribing information for this product can be obtained bycontacting the Company or visiting its website. Additional therapeuticoptions are currently under development at Merck Serono, including'Cladribine Tablets', currently in Phase III and potentially the first oraltherapy for MS, as well as several products in early stage development. MerckSerono also is taking a leading role in developing an understanding of therole of genetics in MS.

About multiple sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory conditionof the central nervous system and is the most common, non-traumatic,disabling neurological disease in young adults. It is estimated that morethan two million people have MS worldwide. While symptoms can vary, the mostcommon symptoms of MS include blurred vision, numbness or tingling in thelimbs and problems with strength and coordination. The relapsing forms of MSare the most common.

About Merck Serono

Merck Serono is the division for innovative prescriptionpharmaceuticals of Merck, a global pharmaceutical and chemical group.Headquartered in Geneva, Switzerland, Merck Serono discovers, develops,manufactures and markets innovative small molecules and biopharmaceuticals tohelp patients with unmet medical needs. Its North American business operatesin the United States and Canada as EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux(R),cetuximab), multiple sclerosis (Rebif(R), interferon beta-1a), infertility(Gonal-f(R), follitropin alpha), endocrine and metabolic disorders (Saizen(R)and Serostim(R), somatropin), (Kuvan(R), sapropterin dihydrochloride) as wellas cardiometabolic diseases (Glucophage(R), metformin), (Concor(R),bisoprolol), (Euthyrox(R), levothyroxine). Not all products are available inall markets.

With an annual R&D expenditure of around EUR 1bn, Merck Seronois committed to growing its business in specialist-focused therapeutic areasincluding neurodegenerative diseases, oncology, fertility and endocrinology,as well as new areas potentially arising out of research and development inautoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company withtotal revenues of EUR 7.6 billion in 2008, a history that began in 1668, anda future shaped by 32,700 employees in 60 countries. Its success ischaracterized by innovations from entrepreneurial employees. Merck'soperating activities come under the umbrella of Merck KGaA, in which theMerck family holds an approximately 70% interest and free shareholders ownthe remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. wasexpropriated and has been an independent company ever since.

For more information, please visit http://www.merckserono.comor http://www.merck.de

http://www.merckserono.com

Merck Serono, 9 Chemin des Mines, 1202 Geneva, Switzerland; Media Relations, Tel.: +41-22-414-36-00

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