New Data Present Comprehensive Long-Term
MRI Evaluation of Total Lesion Area in MS
Serono (virt-x: SEO and NYSE: SRA), Pfizer Inc (NYSE: PFE)
SAN FRANCISCO, April 28 /PRNewswire-FirstCall/ -- New long-term data
supports the importance of early treatment with high dose, high frequency
Rebif(R) (interferon beta-1a) 44 mcg in reducing the long-term accumulation of
brain lesion volume in patients with relapsing remitting multiple sclerosis
(MS). These findings, presented at the 56th Annual Meeting of the American
Academy of Neurology, provide a comprehensive long-term evaluation of MS brain
lesion volume as measured by magnetic resonance imaging (MRI) and show the
sustained effects of Rebif 44 mcg (three times weekly, subcutaneously).
"This is good news for people with relapsing remitting multiple sclerosis
as it shows that earlier initiation of high dose, high frequency interferon
beta-1a therapy with Rebif(R), compared to a two-year delay, is associated
with a greater likelihood of reduction in total lesion accumulation over
time," said Dr. David Li of the University of British Columbia in Vancouver,
British Columbia, Canada.
The findings show that Rebif(R) 44 mcg continued to have an impact in
reducing the accumulation of MS lesion volume, as measured on MRI, in patients
with relapsing remitting MS (RRMS) after 7-8 years of follow up. MRI lesions
provide one of the most sensitive measures of MS disease activity for many
patients. The poster reports the results of long-term changes in the
accumulation of MRI T2 lesion volume among RRMS patients, who were initially
randomized to receive Rebif(R) 44 mcg, Rebif(R) 22 mcg (three times weekly
subcutaneously) or placebo, in the PRISMS(1) long term follow up (LTFU) study.
After the initial two-year time frame, placebo patients commenced therapy with
Rebif(R) for subsequent years.
(1) PRISMS: Prevention of Relapses and disability by Interferon beta-1a
Subcutaneously in Multiple Sclerosis.
The PRISMS LTFU MRI evaluation compared lesion volume change from baseline
to the LTFU visit (an average of 7.4 years later). In the PRISMS LTFU study,
patients initially randomized to Rebif(R) 44 mcg were less likely to have
increased lesion area than those initially given Rebif(R) 22 mcg or placebo
for two years followed by Rebif(R) for up to 5.5 years. The proportion of
patients showing an increase in total lesion burden over an average of 7.4
years was lowest for Rebif(R) 44 mcg (54%), followed by Rebif(R) 22 mcg (66%)
compared to the placebo/Rebif(R) patients (73%). This represents a 26%
relative reduction in the risk of lesion accumulation for Rebif 44 mcg (three
times weekly) initiated early compared to delayed initiation of treatment.
The exact relationship between MRI findings and the clinical status of
patients is unknown.
About the PRISMS and the PRISMS Long-Term Follow Up (LTFU) Studies
The long-term MRI lesion area data come from an observational follow-up of
the patients originally enrolled in the PRISMS study, a double blind,
placebo-controlled study, which began in 1994, and involved 560 patients at 22
centers in 9 countries. Patients were originally randomized to receive
Rebif(R) 44 mcg three times weekly (184 patients), Rebif(R) 22 mcg three times
weekly (189 patients) or placebo (187 patients). After the first two years,
placebo patients were re-randomized to receive one of the two active doses of
Rebif(R), while patients already on active treatment continued with the same
dose. Overall, 68% of the original randomized cohort returned for the Long
Term Follow Up.
The two-year results from the PRISMS study showed that both doses of
interferon beta-1a significantly reduced MRI activity and area, relapse rates,
as well as reduced progression of Expanded Disability Status Scale (EDSS)
scores. Dose-blinded extension data to four years demonstrated sustained
treatment benefit over time, with increasing evidence of a dose-effect that
favored Rebif(R) 44 mcg. The Long-Term Follow Up assessment was then
performed on the seventh or eighth anniversary of patients' enrollment in the
original PRISMS study, and these data provided a comprehensive long-term
clinical and MRI assessment of cohort of MS patients on therapy with
interferon. The LTFU results support the long-term effectiveness of Rebif(R)
44 mcg in the treatment of RRMS.
About Rebif(R)
Rebif(R) (interferon beta-1a) is a disease-modifying drug used to treat
relapsing forms of MS 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, 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.
People in the US with relapsing forms of MS can find more information
about Rebif(R) in the full prescribing information, online at http://www.Rebif.com or
by calling MS LifeLines(TM) toll-free at 1-877-44REBIF (1-877-447-3243).
Patients should be instructed to read the Medication Guide accompanying the
product. 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.
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.
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 seven
recombinant products, Rebif(R), Gonal-F(R), Luveris(R),
Ovidrel(R)/Ovitrelle(R), Serostim(R), Saizen(R) and Zorbtive(TM) (Luveris(R)
is not approved in the USA). In addition to being the world leader in
reproductive health, Serono has strong market positions in neurology,
metabolism and growth. 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).
About Pfizer
Pfizer Inc discovers, develops, manufactures and markets leading
prescription medicines, for humans and animals, and many of the world's
best-known consumer brands.
SOURCE Serono Inc.
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Related links:
http://www.Rebif.com
http://www.serono.com http://www.seronousa.com
CONTACT:
Serono in Geneva, Switzerland: Media
Relations: +41-22-739-36-00, or fax, +41-22-739-30-85, or
Investor Relations: +41-22-739-36-01, or fax, +41-22-739-30-22,
or Serono, Inc., Rockland, MA: Media Relations: Michele Rozen,
+1-781-681-2481, michele.rozen@serono.com, or Investor Relations:
+1-781-681-2552, or fax, +1-781-681-2912; or Alison Lehanski,
Media Relations of Pfizer Inc, New York, NY, +1-212-733-8087,
Alison.lehanski@pfizer.com
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