SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
________
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 October, 2004
Serono S.A.
------------------------------
(Registrant's Name)
15 bis, Chemin des Mines
Case Postale 54
CH-1211 Geneva 20
Switzerland
----------------------------------------
(Address of Principal Executive Offices)
1-15096
------------------------------
(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-F X Form 40-F
----- -----
(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).) ______
(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).) ______
(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
----- -----
(If "Yes" is marked, indicate below the file number assigned to the
registrant in connection with Rule 12g3-2(b): 82-______)
SERONO
MEDIA RELEASE
FOR IMMEDIATE RELEASE
---------------------
FOUR YEAR DATA SHOWS 54% REDUCTION IN RELAPSE RATE AND 76% OF MS PATIENTS REMAIN
FREE OF DISEASE PROGRESSION WITH REBIF(R)
SUSTAINED EFFICACY OF REBIF(R) FURTHER DEMONSTRATED IN LONG TERM DATA
FROM PRISMS STUDY PRESENTED AT THE 20TH ECTRIMS CONGRESS
SERONO (VIRT-X: SEO AND NYSE: SRA) -VIENNA, AUSTRIA, OCTOBER 8, 2004 - Patients
with relapsing-remitting multiple sclerosis (RRMS) who were on placebo and then
treated with Rebif(R) in the PRISMS study showed substantial clinical benefits
with a 54% relative reduction in relapse rate, Serono announced at the 20th
congress of the European Committee for Treatment and Research In Multiple
Sclerosis (ECTRIMS) meeting in Vienna, Austria.
The data also showed a significant improvement in MRI results for patients
treated with Rebif(R) 44 mcg. There was a highly, statistically significant
relative reduction in the mean number of brain lesions(1) of 67%. In addition,
76% of patients treated with Rebif(R) 44 mcg remained free of disease
progression.
"Our results show the immediate and long-term benefits of treatment with
Rebif(R) in controlling MS," said Dr Paul Lammers, Head of Neurology Product
Development at Serono. "This is important news for patients with MS, as these
data further demonstrate that treatment with high-dose, high-frequency
interferon beta-1a can slow disease progression and enable people with relapsing
MS to have an active life longer."
This data is based on a prospective pre-planned analysis of the progress of
patients who received two years of placebo therapy followed by two years of
Rebif(R) in the PRISMS study. The four year PRISMS study demonstrated
significant improvements in the three key efficacy measures of MS: reductions in
MRI lesion area and activity(2), reduced frequency of relapses, and delayed
disability progression. Rebif(R) is the only disease-modifying drug with proven
efficacy in all three measures.
The most frequently reported adverse events were flu-like symptoms and
injection-site reactions, the majority of which were mild. No new safety issues
were noted.
These results are consistent with the PRISMS long-term follow up study, which
showed that patients who started on high-dose and high-frequency Rebif(R) from
the start did the best in terms of disease progression over eight years.
_______________________________
(1) Number of T2 active lesions per patient per scan
(2) The exact relationship between MRI findings and the clinical status of
patients is unknown
1/3
ABOUT THE PRISMS STUDY
The placebo-crossover data come from the PRISMS study, a double blind,
placebo-controlled study, which began in 1994, and involved 560 patients with
RRMS at 22 centers in 9 countries. Patients were originally randomized to
receive Rebif(R) 44 mcg sc tiw (184 patients), Rebif(R) 22 mcg sc tiw (189
patients) or placebo (187 patients). After the first two years, patients who had
received placebo were then re-randomized to receive the active drug at a dose of
22 mcg or 44 mcg sc tiw; all patients were followed for a further two years.
For the placebo-crossover analysis presented today at the 20th ECTRIMS Congress,
only placebo patients with data in both years 1-2 and years 3-4 (n=172/187) were
included for analyses in order to permit within-patient comparisons.
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 (LTFU) 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 multiple sclerosis 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(3), 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.
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.
ABOUT MULTIPLE SCLEROSIS
Multiple sclerosis is a chronic, inflammatory condition of the nervous system
and is the most common, non-traumatic, neurological disease in young adults.
Multiple sclerosis may affect approximately two million people worldwide. While
symptoms can vary, the most common symptoms of multiple sclerosis include
blurred vision, numbness or tingling in the limbs and problems with strength and
coordination. The relapsing forms of multiple sclerosis are the most common.
_______________________________
(3) The exact relationship between MRI findings and the clinical status of
patients is unknown
2/3
###
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 eight biotechnology
products, Rebif(R), Gonal-F(R), Luveris(R), Ovidrel(R)/Ovitrelle(R),
Serostim(R), Saizen(R), Zorbtive(TM) and Raptiva(R) (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 and has
recently entered the psoriasis area. 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).
FOR MORE INFORMATION, PLEASE CONTACT:
CORPORATE MEDIA RELATIONS: CORPORATE INVESTOR RELATIONS:
Tel: +41 22 739 36 00 Tel: +41 22 739 36 01
Fax: +41 22 739 30 85 Fax: +41 22 739 30 22
http://www.serono.com Reuters: SEO.VX / SRA.N
--------------------- Bloomberg: SEO VX / SRA US
MEDIA RELATIONS, USA: INVESTOR RELATIONS, USA:
Tel: +1 781 681 2486 Tel: +1 781 681 2552
Fax: +1 781 681 2935 Fax: +1 781 681 2912
http://www.seronousa.com
------------------------
3/3
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)
October 8, 2004 By: /s/ Francois Naef
-----------------------------------
Name: Francois Naef
Title: Secretary