SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13A-16 OR 15D-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of November, 2002
Serono S.A.
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(Registrant's Name)
15 bis, Chemin des Mines
Case Postale 54
CH-1211 Geneva 20
Switzerland
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(Address of Principal Executive Offices)
1-15096
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(Commission File No.)
(Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.)
Form 20- X FForm 40-F
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(Indicate by check mark if the registrant is submitting the Form 6-K in
paper as permitted by Regulation S-T Rule 101 (b)(1).)
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(Indicate by check mark if the registrant is submitting the Form 6-K in
paper as permitted by Regulation S-T Rule 101 (b)(7).)
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(Indicate by check mark whether the registrant by furnishing the
information contained in this form is also thereby furnishing the information to
the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of
1934.)
Yes No X
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(If "Yes" is marked, indicate below the file number assigned to the
registrant in connection with Rule 12g3-2(b): 82- )
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SERONO PFIZER
[GRAPHIC OMITTED]
FOR IMMEDIATE RELEASE
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MULTIPLE SCLEROSIS PATIENTS ON REBIF(R) MORE LIKELY TO REMAIN RELAPSE FREE THAN
PATIENTS ON AVONEX(R) AT 48 WEEKS
HEAD-TO-HEAD STUDY OF INTERFERON BETA-1A TREATMENTS PUBLISHED IN NEUROLOGY
GENEVA, SWITZERLAND, ROCKLAND, MA, AND NEW YORK, NY, NOVEMBER 25, 2002-SERONO,
S.A. (VIRT-X: SEO AND NYSE: SRA) AND PFIZER INC (NYSE: PFE)
Serono's multiple sclerosis therapy, Rebif(R) (interferon beta-1a), was shown to
be more effective than Avonex(R) (interferon beta-1a) in reducing relapses and
active brain lesions in patients with relapsing remitting MS over 24 and 48
weeks, according to data published in the current edition of the journal
Neurology.(1).
"Now that there are a variety of MS therapies available, it is important that
patients and their physicians have data from a comparative study to help them in
making informed choices," said Hillel Panitch, M.D., a University of Vermont
College of Medicine researcher for the EVIDENCE Study Group. "The publication of
the 48-week study results will enable the MS community to examine in detail the
scientific data supporting the clinical superiority of Rebif(R) over Avonex(R)
at reducing frequency of relapses."
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 up to 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.
The EVIDENCE study, which involved 677 patients with relapsing remitting MS, was
designed to compare the proportion of MS patients treated with either Rebif(R)
or Avonex(R) who were relapse-free after 24 (primary endpoint) and 48 weeks. The
data show that 75% of patients who received Rebif(R) (44 mcg administered
subcutaneously, three times weekly) did not have a relapse after 24 weeks of
treatment compared to 63% of patients treated with Avonex(R) (30 mcg
administered intramuscularly, once weekly) (p<0.001).
-more-
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(1) Panitch H, Goodin DS, Francis G, et al. Randomized, comparative study of
interferon beta-1a treatment regimens in MS: The EVIDENCE Trial. Neurology
2002; 59: 1496-1506.
This improvement was sustained at 48 weeks at which point 62% of Rebif(R)
patients were relapse-free as compared to 52% of Avonex(R) patients (p=0.009).
At 24 and 48 weeks, Rebif(R) patients had a 19% relative increase in remaining
relapse free as compared to Avonex(R) patients.
Magnetic resonance imaging (MRI) was used to assess brain lesions periodically
throughout the 48-week study. Patients treated with Rebif(R) had fewer active
lesions per MRI scan for all activity measures with effects seen within 2-3
months of starting treatment. There was an approximate one-third relative
difference in favor of Rebif(R) and treatment effects were maintained over 48
weeks for measures of lesion activity. The exact relationship between MRI
findings and clinical outcomes for patients is unknown.
Adverse events reported more frequently with Rebif(R) were injection site
reactions (83%), asymptomatic liver function test changes (18%) and white blood
cell abnormalities (11%). These events were generally mild. The incidence of
other events, including flu-like symptoms, did not show a statistically
significant difference between the groups. Serious adverse events and
discontinuations of therapy were also comparable between the groups.
Neutralizing antibodies (NAbs) developed in 25% of the Rebif(R) treated
patients. While the effect of neutralizing antibodies on the efficacy of
treatment with interferon beta-1a is unknown(2), in the EVIDENCE trial, the
development of neutralizing antibodies did not have any observable clinical
impact although a difference on mean MRI lesion count was seen. Development of
neutralizing antibodies did not affect Rebif(R)'s superiority over Avonex(R) on
either the primary endpoint of preventing relapses or on MRI outcome. Patients
receiving Rebif(R) who were NAb-positive had fewer relapses than NAb-negative
patients receiving Avonex(R). The effect of neutralizing antibodies beyond the
48-week term of the study remains to be determined.
ADDITIONAL INFORMATION
Rebif(R) 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(R),
which is co-promoted in the United States by Serono and Pfizer Inc, is the first
and 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(R) was approved in Europe in 1998 and is registered for use in more than
70 countries worldwide. During 2001, Rebif(R) increased its leading position in
these countries as the treatment of choice for patients with relapsing forms of
MS with a market share of 38% in value terms and sales of $379.6m outside the
US.
-more-
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(2) Goodin DS, Frohman EM, Garmany GP, et al. Disease Modifying Therapies in
Multiple Sclerosis. Report of the Therapeutics and Technology Assessment
Subcommittee of the American Academy of Neurology and the MS Council for
Clinical Practice Guidelines. Neurology 2002; 58: 169-178, 175.
The EVIDENCE study was cited in a recent assessment in Neurology(3) of disease
modifying therapies in MS.
In that article, the authors emphasized that EVIDENCE was a randomized
prospective trial in which both the clinical and MRI outcome measures were
assessed in a blinded fashion. As such, the study results qualified as "Class I"
evidence of efficacy, the highest classification rating. The authors also
reiterated the finding that, at six months, relapse and MRI outcome measures for
patients taking Rebif(R) (44 mcg three times weekly) were statistically superior
to outcome measures for patients taking Avonex(R) (30 mcg once weekly).
Further, they recognized that either the dose, or the frequency of
administration or both significantly influenced the treatment outcomes in
patients with RRMS.
US residents can find more information about Rebif(R) in the full prescribing
information, on line at www.rebif.com or by calling MS LifeLines at
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1-877-44REBIF. Patients should be instructed to read the Medication Guide
accompanying the product.
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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 22, 2002. 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, Inc., located in Rockland, MA, is the US affiliate of Serono, S.A., a
global biotechnology leader, headquartered in Geneva, Switzerland. The Company
has six recombinant products on the market, Gonal-F(R) (follitropin alfa for
injection), Luveris(R) (lutropin alfa), Ovidrel(R)/Ovitrelle(R)
(choriogonadotropin alfa for injection), Rebif(R) (interferon beta-1a),
Serostim(R) [somatropin (rDNA origin) for injection] and Saizen(R) [somatropin
(rDNA origin) for injection]. (Luveris(R) is not approved in the USA).(4) 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 seventeen new molecules in development.
In 2001, Serono achieved worldwide revenues of US$1.38 billion, and a net income
of US$317 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 virt-x (SEO) and its American Depositary Shares are traded on
the New York Stock Exchange (SRA).
-more-
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(3) Ibid.
(4) Package inserts for Serono's US products are available at
www.seronousa.com or by calling 1-888-275-7376.
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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.
FOR MORE INFORMATION, PLEASE CONTACT:
MEDIA RELATIONS MEDIA RELATIONS
SERONO, INC. SERONO
ROCKLAND, MA GENEVA, SWITZERLAND:
Tel: +1 781 681 2340 Tel: +41-22 739 36 00
Fax: +1 781 681 2935 Fax +41-22-739 30 85
www.seronousa.com www.serono.com
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INVESTOR RELATIONS
SERONO
GENEVA, SWITZERLAND:
Tel: +41-22 739 36 01
Fax: +41-22 739 30 22
www.serono.com
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MEDIA RELATIONS
PFIZER
NEW YORK, NY
Tel : 212 733 5260
Fax : 212 808 8799
www.pfizer.com
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-end-
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
SERONO S.A.
a Swiss corporation
(Registrant)
November 26, 2002 By: /s/ Jacques Theurillat
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Name: Jacques Theurillat
Title: Deputy Chief Executive Officer