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 June, 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 PFIZER
Media Release
FOR IMMEDIATE RELEASE
---------------------
MS PATIENTS CONVERTING FROM AVONEX(R) TO REBIF(R) SHOWED SIGNIFICANT REDUCTION
IN FREQUENCY OF RELAPSES AND
MRI LESION ACTIVITY
NEW DATA PRESENTED TODAY AT THE
13TH MEETING OF THE EUROPEAN NEUROLOGICAL SOCIETY
GENEVA, SWITZERLAND, ROCKLAND, MA, AND NEW YORK, NY, JUNE 18, 2003 -SERONO, S.A.
(VIRT-X: SEO AND NYSE: SRA) AND PFIZER INC (NYSE: PFE)
Patients who converted from Avonex(R) (interferon beta-1a, 30 mcg once weekly)
to higher dose, higher frequency Rebif(R) (interferon beta-1a, 44 mcg three
times weekly), showed a significant reduction in frequency of relapses and MRI
lesion activity, Serono, S.A. and Pfizer Inc announced today at the 13th Meeting
of the European Neurological Society (ENS) in Istanbul, Turkey.
At the conclusion of the comparative phase of the EVIDENCE(1) study, patients
randomized to Avonex(R) were offered Serono's multiple sclerosis therapy,
Rebif(R). Approximately 73% of Avonex(R) patients (n=223) chose to convert to
Rebif(R). Following their change in therapy, these patients experienced a 50%
relative reduction in the frequency of relapses (0.64 vs. 0.32 annualized rate;
p<0.001) and a 22% relative reduction in MRI lesion activity (mean number of T2
active lesions per patient per scan; 0.9 vs. 0.7; p=0.022) compared to the
previous six months.(2)
"Patients who converted from Avonex(R) to Rebif(R) in the non comparative phase
of the Evidence study experienced improvement in both relapses and MRI lesion
activity that is both clinically meaningful and statistically significant," said
Dr. Mohammad K. Sharief of Guy's Hospital, London, a clinical researcher
presenting the data for the EVIDENCE study group at the ENS Meeting. "These
data provide valuable information for people with relapsing forms of MS and
their physicians in determining whether a change in therapy would be beneficial.
Furthermore, these findings support the results of the comparative phase of the
EVIDENCE study."
-------------------------------
(1)Panitch H, Goodin DS, Francis G, et al. Randomized, comparative study of
interferon beta-1a treatment regimens in MS: The EVIDENCE (Evidence for
Interferon Dose-response European-North American Comparative Efficacy) Trial.
Neurology 2002; 59: 1496-1506.
(2)The exact relationship between MRI findings and clinical outcomes for
patients is unknown.
1/4
The EVIDENCE study, which involved 677 patients with relapsing remitting MS, was
designed to compare the proportion of patients who were treated with either
Rebif(R) (44 mcg three times weekly, subcutaneously) or Avonex(R) (30 mcg once
weekly, intramuscularly) who remained relapse-free after 24 weeks (primary
endpoint) and 48 weeks of therapy. The results showed that patients treated with
Rebif(R) were significantly more likely to remain relapse free at 24 and 48
weeks than were patients treated with Avonex(R). In addition, patients taking
Rebif(R) had fewer active lesions per MRI scan for all studied activity measures
and there was an approximate one-third relative difference in favor of Rebif(R)
for measures of MRI lesion activity.
No new safety issues were noted in the cross-over extension phase of the
EVIDENCE study. Patients converting from Avonex(R) to Rebif(R) experienced an
increase in injection site reactions and in asymptomatic changes in white blood
cell counts and liver function tests. Discontinuation due to adverse events was
5.8%, which is similar to discontinuation due to adverse events for patients on
Rebif(R) during the comparative phase of the EVIDENCE study.
ADDITIONAL INFORMATION
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 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.
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) 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 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.
US residents can find more information about Rebif(R) in the full prescribing
information, on line at WWW.MSLIFELINES.COM or by calling MS LifeLines(TM) 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
2/4
abnormalities. Rebif(R) is contraindicated in patients with hypersensitivity to
natural or recombinant interferon, human albumin, or any other component of the
formulation. Female patients should be informed of potential hazards to a
pregnancy; discontinuation should be considered if pregnancy occurs. Patients,
especially those with depression, seizure disorders, or liver problems, should
discuss with their doctor whether Rebif(R) is right for them.
###
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) (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).(3) 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 2003 Helix 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).
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.
-------------------------------
(3)Package insers for Serono's US marketed products are available at
www.seronousa.com or by calling 1-888-275-7376.
-----------------
3/4
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
----------------- --------------
INVESTOR RELATIONS INVESTOR RELATIONS
SERONO SERONO
GENEVA, SWITZERLAND ROCKLAND, MA
Tel: +41-22 739 36 01 Tel: +781 681 2552
Fax : +41-22 739 30 22 Fax: +781 681 2912
www.serono.com www.seronousa.com
-------------- -----------------
MEDIA RELATIONS
PFIZER
NEW YORK, NY
Tel : 212 733 4889
Fax : 212 808 8799
www.pfizer.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)
June 18, 2003 By: /s/ Allan Shaw
----------------
Name: Allan Shaw
Title: Chief Financial Officer