Study of Effectiveness of Rebif(R) in Secondary Progressive Multiple Sclerosis Published in This Week's Neurology

http://www.newswire.ca/releases/June2001/12/c3110.html

GENEVA, June 12 /CNW/ -- Serono S.A.

(SWX Swiss Exchange: SEO and NYSE: SRA) announces that a study of the effectiveness of Serono's Rebif(R) (interferon beta-1a) in the treatment of secondary progressive multiple sclerosis (SPMS) is included in today's issue of Neurology (1,2).  This publication is one of several this month featuring Serono's extensive multiple sclerosis research program.

Serono has conducted clinical trials across the whole pathology of the disease and now has data from over 3,000 patient years of research concerning the safety and efficacy of interferon therapy for the treatment of patients with relapsing MS.

"In our extensive, highly focused research program, we have now extensively examined the relevant aspects of MS in order to identify the optimal treatment for patients," said Ernesto Bertarelli, CEO of Serono, manufacturer of Rebif(R).  "We now have a clearer indication of how to treat patients with MS most effectively."
 
About SPECTRIMS

The SPECTRIMS study (Secondary Progressive Efficacy Clinical Trial of Rebif(R) in MS) published today showed that the effect on delay of disability in patients with SPMS was more pronounced in earlier stages of the disease, when patients are still experiencing relapses, compared with later stages.
 
Other Clinical Studies

Other studies to be featured this month are PRISMS(3) (Neurology, June 2001), in patients with relapsing-remitting MS, and the EVIDENCE (4) study, which complement the recently published ETOMS(5) study (Lancet, May 2001). All of these involve Serono's interferon beta-1a, Rebif(R).

The PRISMS study shows Rebif(R) 44mcg three times a week to be safe and effective over four years for the treatment of patients with relapsing-remitting MS and was originally the basis of regulatory approval in 67 countries. These data together with the published SPECTRIMS and ETOMS studies demonstrate that Rebif(R) is most effective when administered early in patients with relapsing forms of MS.

Further details on all endpoints of the EVIDENCE study will be announced at a platform presentation at the World Congress of Neurology in London on 22 June 2001.

"The implication of these studies," commented Mark S. Freedman, Professor, Department of Medicine, University of Ottawa, Canada, "is that MS patients with relapses can benefit from interferon beta therapy and unquestionably that high doses of Rebif(R) given frequently as early as possible in the disease achieve the best results."
 
More MS Research Data
 
The key publication of Serono's four-year PRISMS study will appear in Neurology on June 26.  The results of the PRISMS long-term study, which forms the basis for regulatory approval of Rebif(R) in 67 countries, demonstrate that the efficacy of Rebif(R) (interferon beta-1a), given at doses of 22mcg three times a week and 44mcg three times a week, is maintained over four years in patients with relapsing remitting MS.  It also shows that the higher dose of 44mcg three times a week is more effective than the lower dose on all major indicators of disability, relapses, MRI (Magnetic Resonance Imaging) burden of disease and MRI disease activity.  The long-term data from this study show that treating early with the highest tolerable dose of interferon beta-1a results in maximum benefit and delay in disease progression.
 
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 23, 2001.  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, headquartered in Geneva, Switzerland, is a global biotechnology leader. The Company has six recombinant products on the market, Gonal-F(R), Luveris(R), Ovidrel(R), Rebif(R), Serostim(R) and Saizen(R). 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 eleven molecules in development.
 
In 2000, Serono achieved worldwide revenues of US$1.240 billion, and a net income of US$301 million, making it the third largest biotech company in the world based on revenues. The Company operates in 45 countries, and its products are sold in over 100 countries. Bearer shares of Serono S.A., the holding company, are traded on the SWX Swiss Exchange (SEO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA).
 
    For more information, please contact:
    Serono International S.A., Geneva, Switzerland:
    Media Relations:
    Tel:  +41-22-739 36 00
    Fax:  +41-22-739 30 85
    www.serono.com
 
    Investor Relations:
    Tel:  +41-22-739 36 01
    Fax:  +41-22-739 30 22
    Reuters: SEOZ.S/SRA.N
    Bloomberg: SEO SW/SRA US
 
    Noonan/Russo Communications London:
    Tel:  +44-207 726 4452
    Fax:  +44-207 726 4453
    www.noonanrusso.com
 
    Serono, Inc., Norwell, MA
    Media Relations:
    Tel.   +1 781 681 2340
    Fax:   +1 781 982 1369
    www.seronousa.com
 
     (1) Hughes RAC, et al. Randomized controlled trial of interferon-beta-1a
in secondary progressive multiple sclerosis: Clinical Results; Neurology 2001;
June 12th; 56(11): 1496-1504.
     (2) Li DKB, et al. Randomized controlled trial of interferon-beta-1a in
secondary progressive multiple sclerosis: MRI results; Neurology 2001; June
12th; 56(11): 1505-1513.
     (3) The PRISMS (Prevention of Relapses and Disability by Interferon-beta-
1a Subcutaneously in Multiple Sclerosis) Study Group and the University of
British Columbia MS/MRI Analysis Group. PRISMS-4: Long term efficacy of
interferon-beta. -1a in relapsing MS. Neurology 2001 (in press).
     (4) EVidence for Interferon Dose-effect: European-North American
Comparative Efficacy Study. A large (667 patients) controlled, randomized,
rater-blinded, parallel group, multi-center trial (US, Europe, Canada)
comparing Rebif( 44mcg (injected three times weekly Subcutaneously) and
Avonex( 30mcg (injected once weekly intramuscularly) for the treatment of
relapsing-remitting multiple sclerosis (RRMS).
     (5) Comi G, Filippi M, Barkhof F, et al. Early interferon treatment
delays conversion to definite MS - ETOMS study: a double-blind placebo-
controlled randomized study. Lancet 2001; 357: 1576-82.
 
 
For further information:

Serono International, S.A., 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 Noonan-Russo Communications,
+44-207-726-4452, or fax,  +44-207-726-4453; or Serono, Inc., Media Relations,
781-681-2340, or fax,  781-982-1369

Web site:
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                http://www.serono.com
                http://www.seronousa.com