Serono Completes Patient Enrollment in Rebif(R) Versus Copaxone(R) Comparative Clinical Trial
January 05 2005 - 1:00AM
PR Newswire (US)
Serono Completes Patient Enrollment in Rebif(R) Versus Copaxone(R)
Comparative Clinical Trial 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.
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Serono International S.A. 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
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