May 30, 2003
Geneva, Switzerland, Rockland, MA, and New York, NY
SOURCE: Serono, S.A.
Serono, S.A. and Pfizer Inc today announced that the final 63-week findings from the Rebif® (interferon beta-1a) vs. Avonex® (interferon beta-1a) EVIDENCE head-to-head study continue to show that Rebif is significantly more effective in reducing frequency of relapses and MRI activity as compared to Avonex.(1) These newly released data further support the benefit of increased dose and frequency of interferon administration in the treatment of relapsing forms of multiple sclerosis (MS).
The findings are consistent with data comparing Rebif and Avonex at 24 and 48 weeks.(2) The 63-week results will be presented by Hillel Panitch, M.D., a University of Vermont College of Medicine clinical researcher and member of the EVIDENCE Study Group, at the annual meeting of the Consortium of Multiple Sclerosis Centers held this week in San Diego, CA.
"This additional data comparing Rebif and Avonex provides further information for physicians and people with relapsing forms of MS in choosing an interferon treatment," said Dr. Panitch. "It adds to the weight of scientific data supporting the clinical superiority of Rebif over Avonex at reducing frequency of relapses as observed at 24 and 48 weeks," he added.
The EVIDENCE study, which involved 677 patients with relapsing remitting MS, was designed to compare the proportion of MS patients treated with either Rebif (44 mcg three times weekly, subcutaneously) or Avonex (30 mcg once weekly, intramuscularly) who were relapse-free after 24 weeks (primary endpoint) and 48 weeks. Approximately 90% of patients continued in the study for an average of 63 weeks.
EVIDENCE Study data over 63 weeks consistent with previous findings At 63 weeks, 56% of Rebif patients versus 48% of Avonex patients remained relapse free (p=0.023). Rebif patients had a 17% relative increase in the risk to remain relapse free as compared to Avonex patients, and is consistent with previously published EVIDENCE Study data. Other relapse measures such as overall relapse rate, time to first relapse, and steroid use for relapses were also significantly better in Rebif than Avonex patients.
Regarding MRI activity, mean T2 active lesion count was 0.9 for Rebif treated patients and 1.4 for Avonex treated patients (p<0.001); mean proportion of active scans per patient was 27% for Rebif treated patients and 44% for Avonex treated patients (p<0.001); and the proportion of patients with no active scans was 58% for Rebif treated patients and 38% for Avonex treated patients (p<0.001). The exact relationship between MRI findings and clinical outcomes for patients is unknown.
No new safety concerns were noted with comparable numbers of treatment discontinuations in both groups. Adverse events reported more frequently with Rebif 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 than with Rebif (p=0.031).
Multiple sclerosis 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.
Rebif (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis, the most common forms, and is similar to the interferon beta protein produced by the human body. Interferon helps modulate the body's immune system, fights disease and reduces inflammation.
Rebif was approved in the US on March 7, 2002, for the treatment of patients with relapsing forms of multiple sclerosis to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability. Rebif, which is co-promoted in the United States by Serono and Pfizer Inc, is the only drug to gain exception to the marketing exclusivity provision of the Orphan Drug Act based on superior efficacy. The Orphan Drug Act, enacted in the US in 1983, provides drug makers with commercial incentives to encourage the development of treatments for patients with rare and debilitating diseases. Rebif was approved in Europe in 1998 and is registered for use in more than 70 countries worldwide.
US residents can find more information about Rebif in the full prescribing information, on line at http://www.mslifelines.com or by calling MS LifeLines(TM) at 1-877-44REBIF. 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 with their doctors whether Rebif is right for them.
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 April 17, 2003. 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.
(1) The exact relationship between MRI findings and clinical outcomes
for patients is unknown. (2) Panitch H, Goodin DS, Francis G, et al. Randomized,
comparative study of interferon beta-1a treatment regimens in MS: The EVIDENCE
(Evidence for Interferon Dose-response European-North American Comparative
Efficacy) Trial. Neurology 2002; 59: 1496-1506. (3) Package inserts for
Serono's US marketed products are available at http://www.seronousa.com
or by calling 1-888-275-7376.
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