Head-to-Head Trial Will Provide Data on the Comparative Efficacy and
Safety of Rebif(R) and Copaxone(R) in Treatment of Patients with Multiple
Sclerosis
GENEVA, Switzerland, January 5 /PRNewswire-FirstCall/ -- Serono (virt-x:
SEO and NYSE: SRA) announced today that patient enrollment has been completed
in a multi-national Rebif(R) (interferon beta-1a) versus Copaxone(R)
(glatiramer acetate) comparative clinical trial. This two-year trial is
designed to compare the efficacy of the two therapies in patients with
relapsing remitting multiple sclerosis (RRMS), who were previously untreated
with disease modifying therapies.
Over 700 patients have been enrolled and are being treated either with
Rebif(R) 44 mcg administered three times per week by subcutaneous injection
or Copaxone(R) 20 mg administered daily by subcutaneous injection. The
primary outcome of the trial is time to first relapse. Secondary outcomes
include assessments of MRI (magnetic resonance imaging) brain scans and
disability progression. Physicians performing the neurological examinations
and radiologists assessing the MRI scans do not know what treatment each
patient has been allocated to.
"We believe that a head-to-head trial is necessary to provide scientific
data that can be used to compare different therapeutic options. In the past,
we have provided such data, comparing Rebif(R) with Avonex(R) in the landmark
EVIDENCE trial, which allowed Rebif(R) to gain market approval in the U.S.
under the terms of the Orphan Drug Act," said Paul Lammers, Chief Medical
Officer of Serono, Inc. "The ongoing Rebif(R) versus Copaxone(R) trial will
provide comparative data that will support an evidence-based approach for
rational treatment decisions in multiple sclerosis, and we expect the data to
support Rebif(R) as the foundation therapy for treatment of multiple
sclerosis."
Rebif(R) is the only approved MS therapy proven in a four-year clinical
study in all three key measures of treatment effectiveness: reducing MRI
lesion area and activity [1], reducing relapses and delaying the progression
of disability. Rebif(R) is the most prescribed MS disease modifying drug
outside the US and is the fastest growing one in the US.
About EVIDENCE
In the EVIDENCE study, Rebif(R) was shown to be superior over Avonex(R)
in reducing relapses and MRI measures at 24, 48 weeks and at trial completion
(average of 64 weeks) [1]. The study involved 677 patients with relapsing
remitting multiple sclerosis (RRMS), and was designed to compare the
proportion of patients who were treated with either Rebif(R) (44 mcg three
times weekly, subcutaneously) or Avonex(R) (30 mcg once weekly,
intramuscularly) who remained relapse-free after 24 weeks (primary endpoint)
and 48 weeks of therapy. The results showed that patients treated with
Rebif(R) were significantly more likely to remain relapse free at 24 and 48
weeks than were patients treated with Avonex(R). In addition, patients taking
Rebif(R) had fewer active lesions per MRI scan for all studied activity
measures and there was an approximate one-third relative difference in favor
of Rebif(R) for measures of MRI lesion activity. A comparison of safety based
on the EVIDENCE study 48-week results indicates that both Rebif(R) and
Avonex(R) are associated with a similar overall side effect profile,
including flu-like symptoms, headache, fatigue and muscle ache that occur in
about half of the patients treated. Adverse events reported more frequently
with Rebif(R) were injection site reactions, asymptomatic liver function test
changes and white blood cell abnormalities. Flu-like symptoms were reported
in significantly more patients treated with Avonex(R) than with Rebif(R).
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 reduce MRI lesion activity and area [1], reduce the frequency of
relapses, and delay the progression of disability. Rebif(R) is available in a
22 mcg and 44 mcg ready-to-use pre-filled syringe 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 multiple sclerosis
Multiple sclerosis is a chronic, inflammatory condition of the nervous
system and is the most common, non-traumatic, neurological disease in young
adults. Multiple sclerosis may affect approximately two million people
worldwide. While symptoms can vary, the most common symptoms of multiple
sclerosis include blurred vision, numbness or tingling in the limbs and
problems with strength and coordination. The relapsing forms of multiple
sclerosis are the most common.
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 March 25, 2004. 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,
and government regulations limiting our ability to sell our products. Serono
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. Currently, there
are approximately 30 ongoing development projects.
In 2003, Serono achieved worldwide revenues of US$2,018.6 million, and a
net income of US$390.0 million, making it the third largest biotech company
in the world. Its products are sold in over 90 countries. 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.
http://www.serono.com; http://www.seronousa.com
| |
SOURCE Serono International S.A.
 back to top
CONTACT:
Corporate Media Relations: Tel:
+41-22-739-36-00, Fax: +41-22-739-30-85. Corporate Investor
Relations: Tel: +41-22-739-36-01, Fax: +41-22-739-30-22. Media
Relations, USA: Tel: +1-781-681-2340, Fax: +1-781-681-2935.
Investor Relations, USA: Tel: +1-781-681-2552, Fax:
+1-781-681-2912
| |
|
