Thursday March 23, 11:46 am Eastern Time
Company Press Release
SOURCE: Ares-Serono International S.A.
NORWELL, Mass., March 23 /PRNewswire/ -- New data from the largest and most comprehensive controlled long-term study in patients with relapsing- remitting multiple sclerosis (RRMS) using Rebif®, an interferon beta-1a product, points to continued benefit of Rebif® 22 mcg and Rebif® 44 mcg administered three times weekly for four years. Preliminary analysis of the PRISMS(A) four year data report a dose-effect relationship on clinical as well as MRI parameters with high dose Rebif® 3 x 44 mcg being superior to 3x22 mcg. In addition, the data also suggest that early treatment is better than delayed treatment. Together, the data support the benefit of early treatment and treatment with the highest tolerated dose in order to gain maximum benefit and slow disease progression.(B) Rebif® was well-tolerated long-term and side effects were typical of interferon use and were generally mild in severity.
The PRISMS study began in 1994, involving 560 patients at 22 centers in 9 countries. Two year data published© in 1998 reported that both Rebif® 3 x 22 mcg and Rebif® 3 x 44 mcg per week significantly reduced the number and severity of relapses, delayed disability progression and reduced disease activity and burden of disease as measured in magnetic resonance imaging (MRI). The new data are from the extension phase of this study up to four years. Over 90 percent (506) of the originally enrolled patients entered the extension phase and the vast majority of these completed the full four years. The objectives of the extension phase included the assessment of long-term benefits on the frequency of relapses, delay of disability progression, changes in MRI activity and burden of disease, dose-response and the benefit of early versus late therapy onset.
"This is very important data and good news for the multiple sclerosis community. The study was the best designed of any of the trials conducted with interferon in relapsing-remitting multiple sclerosis to date and offers the longest controlled follow-up", comments Mark Freedman, MD, Director of the Multiple Sclerosis Clinic at Ottawa Hospital, General Campus, and Associate Professor of Medicine (Neurology) at the University of Ottawa, an investigator in the PRISMS trial. "It clearly indicates that beta-interferon can dramatically modify the natural course of the disease over four years, an effect that will hopefully continue for even longer. It also reinforces the need to treat as early as possible with the highest tolerable dose."
The detailed PRISMS data will be released to the public at an upcoming major neurological conference. Rebif® is produced and marketed by Ares- Serono and is available in 50 countries worldwide, including Canada, Switzerland, the countries of the European Union, and many in Latin America. However, Rebif® is not on the market in the U.S. where Avonex®(D) and Betaseron®(E) are currently protected from competition under the Orphan Drug Act, a law that offers companies incentives to develop innovative treatments for rare conditions. The Act does allow approval of additional drugs that can clinically demonstrate either safety or efficacy advantages or constitute a major contribution to patient care. Ares-Serono launched a comparative study of Rebif® versus Avonex® in the second half of 1999. The trial of over 600 patients with RRMS compares a 132 mcg weekly subcutaneous dose of Rebif® (44 mcg three times per week), to a 30 mcg per week intramuscularly dose of Avonex® to determine if Rebif®'s higher-dose formulation offers efficacy advantages.
An estimated one to two million people worldwide are living with multiple sclerosis, which is a chronic, debilitating disease of the central nervous system that affects mainly young adults. At present, most patients with MS will become increasingly disabled, but data from trials such as PRISMS suggest that therapies such as Rebif® may beneficially affect the progression of MS.
Ares-Serono, headquartered in Geneva, Switzerland, is a global leader
in biotechnology with its U.S. affiliate, Serono Laboratories, Inc., based
in Norwell, Massachusetts. In addition to being the world leader in reproductive
health with the leading infertility product, Gonal-F®, Ares-Serono
has strong global market positions in HIV-related metabolism (Serostim®)
and growth (Saizen®).(F) Outside of the U.S., the company markets a
high-dose interferon beta-1a product for multiple sclerosis, called Rebif
(R). The company's research programs, which include major R&D operations
in the U.S., are focused on growing its existing businesses and on establishing
new therapeutic areas. In 1999, Ares-Serono achieved worldwide sales of
$1.054 billion, of which one-third were generated in North America. The
company operates in 45 countries, and its products are sold in over 100
countries. Bearer shares of Ares-Serono S.A., the holding company, are
traded on the Swiss SWX stock exchange under the symbol AREB.
For more information, please contact:
U.S. Media Relations:
Serono Laboratories, Inc.
Ares-Serono International S.A.
Tel: +41-22-739 36 01
Fax: +41-22-739 30 22
NOTE(A): PRISMS - Prevention of Relapses and Disability by Interferon Beta-1a Subcutaneously in Multiple Sclerosis.
NOTE(B): 1 Clinical Bulletin, The National Multiple Sclerosis Society, October 1998.
NOTE©: PRISMS Study Group, Randomized Double-Blind Placebo-Controlled
Study of Interferon Beta-1a in Relapsing-
Remitting Multiple Sclerosis. The Lancet. Vol. 352. Nov 7, 1998. 1498-1504.
NOTE(D): Biogen, Inc. (BGEN US)
NOTE(E): Berlex Laboratories, Inc., subsidiary of Schering AG, Germany
NOTE(F): Package inserts for the company's U.S. products, including
Gonal- F® (follitropin alfa for injection), Serostim®
[somatropin (rDNA origin) for injection], and Saizen® [somatropin (rDNA origin) for injection], are available at
www.seronousa.com or by calling 888-275-7376.
SOURCE: Ares-Serono International S.A.