Reformulated Rebif right on track
Merck Serono's revised
formulation of its top seller Rebif (interferon beta-1a) that offers
improved tolerability for multiple sclerosis sufferers has received a
positive opinion from the Committee for Medicinal Products for Human
By Anna Lewcock
The new formulation, which offers a significantly reduced chance of an injection-site reaction, will replace the existing version of Rebif once the anticipated EU approval is granted in the next few months.
the company was unable to disclose a vast amount of detail regarding
the new formulation, Benedicte Bogh, a spokesperson for Merck Serono, did tell in-PharmaTechnologistt.com that the revamped Rebif was formulated without the use of serum.
"Many biotech products use serum to stabilise the protein, but the new Rebif formulation is human serum albumin free," said Bogh.
may have contributed to the products reported improved tolerability and
immunogenicity profile, but further details regarding the new
formulation were seen as too commercially sensitive to reveal.
administration regimen for the new Rebif will be the same as the
current version, administered three times a week by subcutaneous
injection and available in the same strengths and pharmaceutical forms
(i.e. 8.8mcg, 22mcg and 44mcg in pre-filled syringes).
shelf-life of the reformulated product is similar to that of the
current version, and the company claims that it does not expect any
significant price increase, despite the improved profile of the drug.
Although it may only seem a small step, Bogh stresses that the increased tolerability really is "a great technical achievement,"
with cases of injection-site reactions in MS patients who received the
new formulation three times lower than with other treatments.
As well as this, a beneficial effect on immunogenicty was reported due to lower levels of antibody production.
In terms of the impact on revenues generated by the revised formulation, Bogh said that the company expects the new version to "support the strong competitive position" that the current form of Rebif enjoys.
is the company's best-selling product, accounting for 58.1 per cent of
the firm's product sales and generating sales of $1.45bn (€1.1bn)
worldwide over 2006. According to Merck Serono, Rebif is currently the
leading treatment for relapsing MS outside the US, though the company
is expecting to face increased competition from both existing and new
However, in addition to potentially reinforcing
the position of Rebif in the market thanks to the improved formulation,
Merck Serono is also in pole position in the race to be the first on
the market with an oral MS treatment, the race for which is hotting up
as competing companies edge towards late stage clinical trials.
company earlier this year announced that it had completed enrolment in
its Phase III trials for Movectro, its proprietary oral formulation of
cladribine. Although Novartis is not far behind and planning Phase III
trials of its compound FTY720 (fingolimod) and both companies hoping to
file in 2009, according to Bogh the company believes it is "on track to be the first on the market with a disease modifying oral treatment for MS".