One-year Data From Phase III Trial Show That New Formulation of Rebif(r) Offers Substantial Improvement in Tolerability and Immu
28 September 2006 - 4:00PM
PR Newswire (US)
Data Presented at 22nd ECTRIMS Congress in Madrid MADRID, Spain,
September 28 /PRNewswire-FirstCall/ -- Serono (virt-x: SEO and
NYSE: SRA) announced today data from an ongoing two-year (96 weeks)
Phase IIIb trial show that the new formulation of Rebif(R)
(interferon beta-1a) 44 mcg subcutaneously (sc) three times weekly
(tiw) for the treatment of relapsing forms of multiple sclerosis
(MS) offers substantial improvement in tolerability and reduction
in antibody formation observed at one year (48 weeks), compared
with historical data from patients. Historical data for the
currently available formulation of Rebif(R) is the EVIDENCE study.
These data are presented today at a satellite symposium at the 22nd
Congress of the European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS) in Madrid, Spain. "These results are
promising news for patients with multiple sclerosis," said Prof Per
Soelberg Sorensen, from the Danish MS Research Center, Copenhagen
University Hospital, Rigshospitalet and an investigator of the
trial. "If approved the new formulation of Rebif(R) potentially
represents an improvement in the treatment of patients with
multiple sclerosis." The incidence of injection site reactions with
the new formulation of Rebif(R) at 48 weeks was nearly three-fold
less than in the EVIDENCE study (29.6% versus 83.8%). Injection
site reactions are one of the reasons why some patients discontinue
MS treatment. Treatment enhancements resulting in a decrease of
injection site reactions are usually associated with improved
compliance and adherence to treatment. The primary endpoint of the
study is the proportion of neutralizing antibody positive patients
at the last assessment. At 48 weeks, the data showed that 13.9% of
patients treated with the new formulation of Rebif(R) were
neutralizing antibody positive. In the EVIDENCE study at 48 weeks,
24.4% of the patients were positive. Persistent neutralizing
antibodies were detected in 2.5% of the patients treated with the
new formulation of Rebif(R) at 48 weeks. In the EVIDENCE study at
48 weeks, the rate of persistent neutralizing antibodies observed
was 14.3%. "The new formulation of Rebif(R) has been developed by
an innovative approach, using state-of-the-art technologies, with a
major focus on the molecule's structural and functional integrity,"
said Franck Latrille, Senior Executive Vice President Global
Product Development at Serono. "Based on the improvements in
tolerability and immunogenicity, the new formulation of Rebif(R)
could lead to an improved benefit-to-risk profile." The new
formulation of Rebif(R) is the latest of many product developments
from Serono to continually enhance the convenience and tolerability
of Rebif(R). Other enhancements have included the Rebiject II
auto-injector to facilitate injections; a 29 gauge-5 bevel needle
pre-filled syringe, the thinnest needle in a ready-to-use
pre-filled syringe for the treatment of MS; and a titration pack
designed to make starting on Rebif(R) therapy easier and more
convenient. The new formulation of Rebif(R) is currently under
regulatory review by the European Medicines Agency, the US Food and
Drug Administration and other healthcare authorities. The results
presented today are the 48-week results from a 96-week, Phase IIIb,
multicenter, single-arm, open-label study evaluating the safety and
immunogenicity of the new formulation of Rebif(R) 44 mcg sc tiw in
260 patients with relapsing forms of MS. The primary objective of
the study was to compare the antigenicity of new formulation Rebif
to historical data. About Rebif(R) Rebif(R) (interferon beta-1a) is
a disease-modifying drug used to treat relapsing forms of multiple
sclerosis and is similar to the interferon beta protein produced by
the human body. Interferon helps modulate the body's immune system,
fight disease and reduce inflammation. Rebif(R), which was approved
in Europe in 1998 and in the US in 2002, is registered in more than
80 countries worldwide. In the United States, Rebif(R) is
co-marketed by Serono, Inc. and Pfizer Inc. Rebif(R) has been
proven to delay the progression of disability, reduce the frequency
of relapses and reduce MRI lesion activity and area[1]. Rebif(R) is
available in a 22 mcg and 44 mcg ready-to-use pre-filled syringe
and a titration pack, and can be stored at room temperature for up
to 30 days if a refrigerator is not available. Most commonly
reported side effects are injection site disorders, flu-like
symptoms, 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. About Serono Neurology In addition to Rebif(R), Serono
also offers a second therapy within its US portfolio of multiple
sclerosis (MS) therapies: Novantrone(R) (mitoxantrone for injection
concentrate) for worsening forms of MS. Full prescribing
information for these products can be obtained by contacting Serono
or visiting the Serono website. Additional therapeutic options are
currently under development at Serono, including oral cladribine,
currently in Phase III studies and potentially the first oral
therapy for treatment of MS, as well as several products in early
stage development including: osteopontin, an MMP-12 inhibitor, a
JNK inhibitor and interferon beta:Fc. Serono also is taking a
leading role in developing an understanding of the role of genetics
in MS, with a whole genome scan currently underway. To-date, 80
genes associated with MS have been identified, based on a 40% scan.
The project is due to be completed in 2006 and will improve
understanding of the causes of MS and the appropriate therapeutic
targets for the disease. About multiple sclerosis Multiple
sclerosis (MS) is a chronic, inflammatory condition of the nervous
system and is the most common, non-traumatic, neurological disease
in young adults. MS may affect approximately two million people
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. Background material For free B-roll, video and
other content for Serono and its products, please visit the Serono
Media Center http://www.thenewsmarket.com/Serono. You can download
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media. Forward-looking statements Some of the statements in this
press release are forward looking. Such statements are inherently
subject to known and unknown risks, uncertainties and other factors
that may cause actual results, performance or achievements of
Serono S.A. and affiliates to be materially different from those
expected or anticipated in the forward-looking statements.
Forward-looking statements are based on Serono's current
expectations and assumptions, which may be affected by a number of
factors, including those discussed in this press release and more
fully described in Serono's Annual Report on Form 20-F filed with
the U.S. Securities and Exchange Commission on February 28, 2006.
These factors include any failure or delay in Serono's ability to
develop new products, any failure to receive anticipated regulatory
approvals, any problems in commercializing current products as a
result of competition or other factors, our ability to obtain
reimbursement coverage for our products, the outcome of any
government investigations and litigation. Serono is providing this
information as of the date of this press release, and has no
responsibility to update the forward-looking statements contained
in this press release to reflect events or circumstances occurring
after the date of this press release. About Serono Serono is a
global biotechnology leader. The Company has eight biotechnology
products, Rebif(R), Gonal-f(R), Luveris(R), Ovidrel(R
)/Ovitrelle(R), Serostim(R), Saizen(R), Zorbtive(TM) and
Raptiva(R). In addition to being the world leader in reproductive
health, Serono has strong market positions in neurology, metabolism
and growth and has recently entered the psoriasis area. The
Company's research programs are focused on growing these businesses
and on establishing new therapeutic areas, including oncology and
autoimmune diseases. In 2005, Serono, whose products are sold in
over 90 countries, achieved worldwide revenues of US$2,586.4
million. Reported net loss in 2005 was US$106.1 million, reflecting
a charge of US$725 million taken relating to the settlement of the
US Attorney's Office investigation of Serostim. Excluding this
charge as well as other non-recurring items, adjusted net income
grew 28.4% to US$565.3 million in 2005. Bearer shares of Serono
S.A., the holding company, are traded on the virt-x (SEO) and its
American Depositary Shares are traded on the New York Stock
Exchange (SRA). [1] The exact relationship between MRI findings and
the clinical status of patients is unknown. DATASOURCE: Serono
International S A CONTACT: For more information, please contact:
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