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 April, 2004
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-F X Form 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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[GRAPHIC OMITED]
MEDIA RELEASE
FOR IMMEDIATE RELEASE
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MS PATIENTS TAKING HIGH DOSE HIGH FREQUENCY REBIF(R) SUSTAINED REDUCTION IN
ACCUMULATION OF MRI BRAIN LESIONS OVER LONG TERM
NEW DATA PRESENT COMPREHENSIVE LONG-TERM
MRI EVALUATION OF TOTAL LESION AREA IN MS
SERONO (VIRT-X: SEO AND NYSE: SRA), PFIZER INC (NYSE: PFE)
SAN FRANCISCO, CA (APRIL 28, 2004) - New long-term data support the importance
of early treatment with high dose, high frequency Rebif(R) (interferon beta-1a)
44 mcg in reducing the long-term accumulation of brain lesion volume in patients
with relapsing remitting multiple sclerosis (MS). These findings, presented at
the 56th Annual Meeting of the American Academy of Neurology, provide a
comprehensive long-term evaluation of MS brain lesion volume as measured by
magnetic resonance imaging (MRI) and show the sustained effects of Rebif 44 mcg
(three times weekly, subcutaneously).
"This is good news for people with relapsing remitting multiple sclerosis as it
shows that earlier initiation of high dose, high frequency interferon beta-1a
therapy with Rebif(R), compared to a two-year delay, is associated with a
greater likelihood of reduction in total lesion accumulation over time," said
Dr. David Li of the University of British Columbia in Vancouver, British
Columbia, Canada.
The findings show that Rebif(R) 44 mcg continued to have an impact in reducing
the accumulation of MS lesion volume, as measured on MRI, in patients with
relapsing remitting MS (RRMS) after 7-8 years of follow up. MRI lesions provide
one of the most sensitive measures of MS disease activity for many patients. The
poster reports the results of long-term changes in the accumulation of MRI T2
lesion volume among RRMS patients, who were initially randomized to receive
Rebif(R) 44 mcg, Rebif(R) 22 mcg (three times weekly subcutaneously) or placebo,
in the PRISMS(1) long term follow up (LTFU) study. After the initial two-year
time frame, placebo patients commenced therapy with Rebif(R) for subsequent
years.
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1 PRISMS: Prevention of Relapses and disability by Interferon beta-1a
Subcutaneously in Multiple Sclerosis.
1/3
The PRISMS LTFU MRI evaluation compared lesion volume change from baseline to
the LTFU visit (an average of 7.4 years later). In the PRISMS LTFU study,
patients initially randomized to Rebif(R) 44 mcg were less likely to have
increased lesion area than those initially given Rebif(R) 22 mcg or placebo for
two years followed by Rebif(R) for up to 5.5 years. The proportion of patients
showing an increase in total lesion burden over an average of 7.4 years was
lowest for Rebif(R) 44 mcg (54%), followed by Rebif(R) 22 mcg (66%) compared to
the placebo/Rebif(R) patients (73%). This represents a 26% relative reduction
in the risk of lesion accumulation for Rebif 44 mcg (three times weekly)
initiated early compared to delayed initiation of treatment. The exact
relationship between MRI findings and the clinical status of patients is
unknown.
ABOUT THE PRISMS AND THE PRISMS LONG-TERM FOLLOW UP (LTFU) STUDIES
The long-term MRI lesion area data come from an observational follow-up of the
patients originally enrolled in the PRISMS study, a double blind,
placebo-controlled study, which began in 1994, and involved 560 patients at 22
centers in 9 countries. Patients were originally randomized to receive Rebif(R)
44 mcg three times weekly (184 patients), Rebif(R) 22 mcg three times weekly
(189 patients) or placebo (187 patients). After the first two years, placebo
patients were re-randomized to receive one of the two active doses of Rebif(R),
while patients already on active treatment continued with the same dose.
Overall, 68% of the original randomized cohort returned for the Long Term Follow
Up.
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 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 MS 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, 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.
People in the US with relapsing forms of MS can find more information about
Rebif(R) in the full prescribing information, online at www.Rebif.com or by
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calling MS LifeLines(TM) toll-free at 1-877-44REBIF (1-877-447-3243). 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
treatment with Rebif(R) with their doctors.
MS 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.
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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 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.
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ABOUT SERONO
Serono is a global biotechnology leader. The Company has seven recombinant
products, Rebif(R), Gonal-F(R), Luveris(R), Ovidrel(R)/Ovitrelle(R),
Serostim(R), Saizen(R) and Zorbtive(TM) (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. 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).
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:
SERONO IN GENEVA, SWITZERLAND:
MEDIA RELATIONS: 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
SERONO, INC., ROCKLAND, MA
MEDIA RELATIONS: INVESTOR RELATIONS:
Michele Rozen Tel. +1 781 681 2552
Tel: +1 781 681 2481 Fax: +1 781 681 2912
Email: michele.rozen@serono.com
http://www.seronousa.com
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PFIZER INC, NEW YORK, NY
MEDIA RELATIONS:
Alison Lehanski
Tel: +1 212 733 8087
Email: Alison.lehanski@pfizer.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)
April 28, 2004 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer