European Commission Approves Revision of Therapeutic Indication for Rebif(R)
10 July 2006 - 4:00PM
PR Newswire (US)
Throughout the European Union, Multiple Sclerosis Patients Can Now
Benefit From Rebif(R) as Soon as Their Diagnosis of MS is Confirmed
GENEVA, Switzerland, July 10 /PRNewswire-FirstCall/ -- Serono
(virt-x:SEO and NYSE: SRA) announced today that the European
Commission has approved an update of the Summary of Product
Characteristics (SmPC) of Rebif(R) (interferon beta-1a), in order
to align it with current medical practice. Throughout the European
Union, Rebif(R) can now be prescribed after the diagnosis of
multiple sclerosis (MS) has been confirmed based on one attack and
subsequent positive magnetic resonance imaging (MRI) scans. The
'therapeutic indication' section of the SmPC of Rebif(R) now takes
into account the McDonald criteria, which are the current reference
criteria for the diagnosis of MS. The SmPC of Rebif(R) was
previously based on the Poser criteria, which were in use at the
time of Rebif(R) approval in the European Union in 1998, and
Rebif(R) was consequently indicated for MS patients who had
experienced at least two attacks. Compared with the Poser criteria,
the McDonald criteria utilize MRI evidence as an alternative to a
second attack, and allow the same patients to be diagnosed with
more sensitivity and specificity. Current understanding of the
disease supports that it is critical to initiate treatment as soon
as the diagnosis of MS is established to ensure the best possible
outcome for the patients. "We are delighted with the European
Commission decision," said Roberto Gradnik, Senior Executive Vice
President Europe at Serono. "MS has an initial stage when clinical
manifestations are not pronounced but irreversible neurological
damage is taking place. This neurological damage determines the
relative risk of progression of the disease. People with MS living
in Europe will be able to benefit from the proven efficacy of
Rebif(R) as soon as MS is diagnosed, when it is needed most."
Rebif(R) is proven effective on the following three key measures of
treatment effectiveness: MRI lesion area and activity, relapse
rates, and disability progression. The safety and efficacy of
Rebif(R) are supported by eight-year follow-up data and 12 years of
patient experience from around the world. The European Commission
decision means that the updated SmPC of Rebif(R) is valid
immediately in all 25 member states of the European Union. In most
other regions of the world, the therapeutic indication of Rebif(R)
already takes into account the McDonald criteria. 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 therapy options are currently under
development at Serono, including cladribine tablets, currently in
Phase III studies and potentially the first oral therapy for
treatment of MS, as well as osteopontin, an MMP-12 inhibitor, a JNK
inhibitor and interferon beta:Fc, in early-stage development for
MS. 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 print-quality
images and receive broadcast-standard video digitally or by tape
from this site. Registration and video is free to the media. 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 government investigations and litigation 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, including oncology and
autoimmune diseases. Currently, there are more than 25 on-going
development projects. 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). http://www.serono.com/ http://www.seronousa.com/
Reuters: SEO.VX / SRA.N Bloomberg: SEO VX / SRA US [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: 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
Copyright