Merck Serono to Introduce RebiDose(TM), the Rebif(R) Single Use Pre-filled Pen for Treatment of Multiple Sclerosis

By Merck Serono, PRNE
Thursday, October 14, 2010

RebiDose(TM) has Been Developed With the Goal to Simplify the Rebif(R) Injection Process and Potentially Improve Patient Convenience

GENEVA, October 15, 2010 - Merck Serono, a division of Merck KGaA, Darmstadt, Germany,
announced today the upcoming introduction of the new device RebiDose(TM), the
Rebif(R) single use pre-filled pen, for the self-administration of Rebif(R)
(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(TM) to meet the needs of patients looking for simple and minimum
injection preparation," said Roberto Gradnik, Head of Global Business Unit
Neurodegenerative Diseases at Merck Serono. "The introduction of
RebiDose(TM), alongside RebiSmart(TM), 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(TM) 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(TM) used with Rebif(R) 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(TM) 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(TM) user trial showed that the
majority of patients 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(TM) if it became available. The RebiDose(TM)
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.

About the RebiDose(TM) user trial

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

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(R), 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(TM) 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(TM), has not been approved in the US.

About Rebif(R)

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 90 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 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(TM)
device, in several EU member countries, Switzerland and Canada, as well as in

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

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
and Canada, EMD Serono operates through separately incorporated

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 R&D 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.

About Merck

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 (including Merck Millipore) 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.

For more information, please visit

Media relations: Tel: +41-22-414-36-00

will not be displayed