GENEVA, October 15, 2010 /PRNewswire/ -- 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 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(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
Australia.
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 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 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 http://www.merckserono.com or
http://www.merck.de