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 September, 2003
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
---------------------
NEW POSITIVE LONG-TERM RESULTS FOR
REBIF(R) MULTIPLE SCLEROSIS TREATMENT PRESENTED AT ECTRIMS
EIGHT-YEAR DATA IN RELAPSING REMITTING MS SUPPORT USE OF REBIF(R)
GENEVA, SWITZERLAND, SEPTEMBER 19, 2003-SERONO, S.A. (VIRT-X: SEO AND NYSE: SRA)
New data from a long-term assessment of a cohort of patients with
relapsing-remitting multiple sclerosis (RRMS) on Rebif(R) (interferon beta-1a)
therapy will be presented today at the 19th Congress of the European Committee
for Treatment and Research In Multiple Sclerosis (ECTRIMS) in Milan, Italy. The
data will be included in a poster session presented by Professor Ludwig Kappos
of the Neurologische Universitatsklinik und Poliklinik in Basel, Switzerland.
The results support the long-term benefit of Rebif(R) 44 mcg subcutaneously (sc)
three times weekly (tiw), in the treatment of RRMS on relapses, disability and
magnetic resonance imaging (MRI) outcomes measured, with a favorable risk
benefit profile through eight years. The exact relationship between MRI findings
and clinical outcomes for patients is unknown.
"These are very important data and good news for the multiple sclerosis (MS)
community, said Dr. Donald W. Paty of the University of British Columbia,
Vancouver, Canada, an investigator in the PRISMS(1) trial. "These findings
support Rebif(R)'s effectiveness and show that it is generally well-tolerated
for eight years duration of treatment and that it appears to modify the natural
course of the disease. These data provide additional support to the concept of
treating MS patients with high dose high frequency interferon beta in order to
gain maximum benefit and prevent disease progression."
In those patients returning for long-term follow-up (LTFU) assessment,
approximately 1 in 5 progressed to secondary progressive multiple sclerosis
(SPMS). Natural history data from two population-based studies in Canada and
Sweden suggest that approximately 1 in 2 patients would have been expected to
have progressed to SPMS without treatment.(2) However, differences between
study patients and natural history cohorts may exist.
_____________________
(1) PRISMS (Prevention of Relapses and disability by Interferon beta-1a
Subcutaneously in MS)
(2) B.G. Weinshenker et al. "The natural history of multiple sclerosis: a
geographically based study." Brain (1989), 112: 133-146 B. Runmarker et al.
"Prognostic factors in a multiple sclerosis incidence cohort with
twenty-five years of follow-up" Brain (1993), 116: 117-134
1/4
The eight-year extension data come from an open-label follow-up of 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 sc tiw (184 patients), Rebif(R) 22 mcg sc
tiw (189 patients) or placebo (187 patients). After the first two years, placebo
patients were re-randomized to receive one of the two active doses, while
patients already on active treatment continued with the same dose.
A LTFU assessment was performed to coincide with the seventh or eighth
anniversary of the first patient visit after enrollment in the original study.
Safety, efficacy and antigenicity evaluations were performed as well as
retrospective collection of efficacy outcomes since the last evaluative visit in
PRISMS. Patients originally randomized to placebo have received active therapy
for the intervening time until the LTFU assessment.
A total of 68% (382/560) of the patients in the original randomized cohort
returned for the LTFU visit including 74% (136/184) of the patients originally
randomized to Rebif(R) 44 mcg sc tiw. Of these, almost three-quarters were being
treated with Rebif(R) tiw at the time of the LTFU visit, reflecting long-term
compliance to high dose, high frequency interferon beta treatment.
Rebif(R) was generally well tolerated in those seen at the LTFU visit. The most
frequently reported adverse events at the time of the LTFU visit were flu-like
symptoms and injection-site reactions, the majority of which were mild. Other
adverse events generally associated with interferon beta therapy occurred
infrequently.
Neutralizing antibody (NAb) rate was 12% (22/184) at the last available
assessment in patients randomized to Rebif(R) 44 mcg sc tiw. The clinical
implications of NAb development in patients with relapsing forms of MS have not
been fully studied and remain unknown.
Benefit for patients initially randomized to Rebif(R) 44 mcg sc tiw, compared
with those patients initially randomized to placebo and who had been on IFN
therapy for up to 5-6 years, was seen on time to progression on a disability
scale, time to SPMS, annualized relapse rate, and change in lesion area as
measured in MRI. Given that patients initially randomized to placebo have been
treated for up to 75% of the observation period with active drug, and that
patients could have changed doses or medications, the power of the study to
detect differences between original randomization groups is limited.
ADDITIONAL INFORMATION
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-promoted by Serono and Pfizer Inc.
2/4
People in the US with relapsing forms of MS can find more information about
Rebif(R) in the full prescribing information, online at www.mslifelines.com or
-------------------
by calling MS LifeLines(TM) toll-free at 1-877-44REBIF. 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 with their
doctors whether Rebif(R) is right for them.
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.
###
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 17, 2003. 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 six recombinant
products on the market, Gonal-F(R), Luveris(R), Ovidrel(R)/Ovitrelle(R),
Rebif(R), Serostim(R) and Saizen(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. The Company's research
programs are focused on growing these businesses and on establishing new
therapeutic areas. Currently, there are over 30 projects in development.
Serono was awarded the International James D. Watson Helix 2003 Award from the
Biotechnology Industry Organization (BIO) in recognition of the Company's
outstanding leadership and highest standards of scientific and product
achievement.
In 2002, Serono achieved worldwide revenues of US$1.546 billion, and a net
income of US$321 million, making it the third largest biotech company in the
world. 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).
3/4
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: SEOZ.VX / SRA.N
--------------------- Bloomberg: SEO VX / SRA US
SERONO, INC., ROCKLAND, MA
MEDIA RELATIONS: INVESTOR RELATIONS:
Tel. +1 781 681 2340 Tel. +1 781 681 2552
Fax: +1 781 681 2935 Fax: +1 781 681 2912
http://www.seronousa.com
------------------------
4/4
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)
September 22, 2003 By: /s/ Allan Shaw
-----------------------
Name: Allan Shaw
Title: Chief Financial Officer