Merck Serono, a division of Merck KGaA, has announced that Rebif® New
Formulation (interferon beta-1a) will be available in the UK. In a recent
two-year (96 week) Phase IIIb study, 260 patients with relapsing remitting
multiple sclerosis treated with the new formulation experienced a near
three-fold reduction in injection-site reactions. These results are compared
with historical data for the previous formulation of Rebif (30.8% versus
"Rebif is an established first line disease modifying treatment
for relapsing types of MS" said Professor Gavin Giovannoni from The Royal London
Hospital. "Injection site reactions can lead to discontinuation of therapy in
some patients2, the notable reduction in these reactions with Rebif New
Formulation has positive implications for treatment tolerability and adherence."
Rebif has a favorable benefit-to-risk profile3 and has a proven efficacy
and safety profile, which has been demonstrated consistently across numerous
phase III clinical trials and clinical practice1,4-6. The new formulation has
consistent efficacy compared with previous experience1. At 96 weeks, 53.3% of
patients remained relapse-free and overall the expanded disability status scale
(EDSS) score remained stable throughout the study1.
The New Formulation
of Rebif is the first and only therapy for multiple sclerosis that is serum-free
both from animal (foetal bovine serum) and human (human serum albumin) derived
components in either the manufacturing process or as excipients.
formulation of Rebif® was approved on August 10, 2007, by the European
Commission and will be phased in to replace Rebif® original formulation from 1st
March 2008. References
1. Giovannoni G, Barbarash OL,
Casset-Semanaz F, et al.
on behalf of the RNF Study Group Safety and
immunogenicity of interferon beta-1a (Rebif® New Formulation) in a phase IIIb
study in patients with relapsing multiple sclerosis: 96-week results. Program
and abstracts of the 23rd 22nd Congress of the European Committee for Treatment
and Research in Multiple Sclerosis; October 11-14, 2007; Prague, Czech
2. Tremlett HL and Oger J. Stopping and switching of the
ß-interferons prescribed for MS. Neurology 2003; 61:551-554
GS. Importance of benefit-to-risk assessment for disease-modifying drugs used to
treat MS. J Neurol
2004; 251 (Suppl 5): v42-9.
4. Li D, Paty D,
UBC MS/MRI Analysis Research Group, PRISMS Study Group. Magnetic resonance
imaging results of the PRISMS trial: a randomized, double-blind, placebo
controlled study of interferon-b1a in relapsing-remintting multiple sclerosis.
1999; 46: 197-206
5. PRISMS (Prevention of Relapses and
Disability by Interferon beta-1a Subcultaneously in Multiple Sclerosis) Study
Group. Randomised double-blind placebo-controlled study of interferon beta-1a in
relapsing/remitting multiple sclerosis. Lancet
1998; 352: 1498-504,
Erratum in Lancet
1999; 353; 678.
6. PRISMS Study Group,
University of British Columbia MS/MRI Analysis Group. PRISMS-4: Long-term
efficacy of interferon-β-1a in relapsing MS. Neurology
2001; 56: 1628-36.
About the Rebif® New Formulation 96 week study
was a two-year (96 weeks) Phase IIIb, international, multicenter, single-arm,
open-label study with historical controls, evaluating the safety and
immunogenicity of the new formulation of Rebif® (interferon beta-1a) 44
micrograms (mcg) subcutaneously (sc) three times weekly (tiw) in 260 patients
with relapsing forms of multiple sclerosis (MS).
No unexpected adverse
events were reported with the new formulation of Rebif®. Safety outcomes were
consistent with the known profile of Rebif®. The majority of adverse events were
mild or moderate in severity. The most frequent side effect was flu-like
symptoms (71.5%), which is typical of interferon therapy; most were mild in
severity. Flu-like symptoms are transient. Prophylactic antipyretic treatment is
recommended. 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.
Interferon helps modulate the body's immune system and reduce inflammation.
Rebif®, which was approved in Europe in 1998 and in the US in 2002, is
registered in more than 80 countries worldwide. Rebif® has been proven to delay
the progression of disability, reduce the frequency of relapses and reduce MRI
lesion activity compared to placebo**. Rebif® is not approved for treatment of
chronic progressive MS. Rebif® is available in a 22 mcg and 44 mcg ready-to-use
pre-filled syringe and a titration pack (8.8 mcg and 22mcg).
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 Merck Serono and
Merck Serono is a leader in multiple sclerosis
(MS) with Rebif® (interferon beta-1a), a disease-modifying drug used to treat
relapsing forms of MS, which is registered in more than 80 countries worldwide.
Product information can be obtained by contacting the Company or visiting its
website. Additional therapeutic options are currently under development at Merck
Serono, including cladribine, currently in Phase III, as well as several
products in early stage development. Merck Serono also is taking a leading role
in developing an understanding of the role of genetics in MS. About
Multiple sclerosis (MS) is a chronic, inflammatory
condition of the nervous system and is the most common, non-traumatic,
neurological disease in young adults. The World Health Organization estimates
that up to 2.5 million people suffer from 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, the
new division for innovative small molecules and biopharmaceuticals of Merck was
established following the acquisition of Serono and the integration of its
business with the former Merck Ethicals Division. Headquartered in Geneva,
Switzerland, Merck Serono discovers, develops, produces and commercializes
innovative products to help patients with diseases with unmet needs. Our North
American business operates in the United States and Canada under EMD Serono. http://www.merckserono.net
Merck Serono has leading
brands serving patients with cancer, metabolic and cardiometabolic disorders, as
well as psoriasis. With an annual R&D investment of EUR 1bn, we are
committed to growing our business in specialist-focused therapeutic areas such
as Neurology and Oncology, as well as new therapeutic areas potentially arising
out of our research and development in autoimmune and inflammatory diseases.
Merck is a global pharmaceutical and chemical
company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and
a future shaped by 35,091 employees in 62 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. http://www.merck.com