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 May, 2003
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).) ______
(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
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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-______)
SERONO PFIZER
MEDIA RELEASE
FOR IMMEDIATE RELEASE
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REBIF(R) LABELING CHANGES REFLECT EFFICACY AND CONVENIENCE OF THE FASTEST
GROWING MS TREATMENT IN THE U.S.
UPDATED LABEL SAYS PATIENTS TREATED WITH REBIF(R) ARE MORE LIKELY TO REMAIN
RELAPSE FREE AT 24 AND 48 WEEKS
VS. PATIENTS TREATED WITH AVONEX(R)
ROCKLAND, MA, AND NEW YORK, NY, MAY 22, 2003 - Serono, Inc. and Pfizer Inc,
co-promoters of Rebif(R) (interferon beta-1a) in the US, announced today that
the U.S. Food and Drug Administration (FDA) has approved additional efficacy and
product stability information for Rebif(R). The new label changes reflect the
treatment's efficacy and convenience in treating multiple sclerosis.
The new labeling changes include an update to the Clinical Studies section to
add 48-week data from the EVIDENCE study(1). This head-to-head study of Rebif(R)
and Avonex(R) (interferon beta-1a) compared the proportion of MS patients
treated with Rebif(R) or Avonex(R) who were relapse free after 24 weeks (primary
end point) and 48 weeks. The label expansion will now reflect that, "Patients
treated with Rebif(R) 44 mcg sc tiw were more likely to remain relapse free at
24 and 48 weeks than were patients treated with Avonex(R) 30 mcg im qw."
"Serono and Pfizer are pleased with the FDA's approval of the new label changes
for Rebif(R). The label expansion reflects additional scientific data
demonstrating Rebif(R)'s clinical superiority over Avonex(R) at reducing
frequency of relapses in patients with relapsing remitting MS at both 24 and 48
weeks," said Gordon Francis, M.D., Vice President, Neurology Clinical
Development Unit, Serono, Inc.
Furthermore, the FDA also approved label changes related to Rebif(R) temporary
storage at room temperature. This change enhances Rebif(R)'s ease-of-use for
people who are currently taking the therapy to treat their MS. The label
expansion will include that, "Rebif(R) may be stored at or below 25 degrees C/77
degrees F for up to 30 days and away from heat or light" and will be reflected
in the Stability and
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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 (Evidence for
Interferon Dose-response European-North American Comparative Efficacy) Trial.
Neurology 2002; 59: 1496-1506.
Storage section. The same room temperature storage conditions were already
allowed in the other countries where Rebif is approved.
"With Rebif(R)'s temporary room temperature labeling, we are building on our
commitment to offer consumers not only a highly efficacious MS treatment, but
also the added convenience that patients seek," said Deborah Brown, Executive
Vice President, Neurology, Serono, Inc.
Christy Demory, an attorney from North Carolina, who takes Rebif(R), welcomed
the change. "Between family and work, I am always on the go and sometimes need
to carry Rebif(R) with me to my office or on an overnight outing or when I
travel, so it's great to have the flexibility of leaving it out at room
temperature," she said. "It's one less thing I have to think about."
A revised patient Medication Guide will also be available that reflects new
storage and needle disposal information.
48-WEEK EVIDENCE DATA SUMMARIZED
The expanded Rebif(R) label now contains data from the head-to-head EVIDENCE
study of 677 patients with relapsing remitting MS. The study compared the
proportion of MS patients treated with either Rebif(R) or Avonex(R) who were
relapse-free after 24 weeks (primary endpoint) and 48 weeks. The data showed
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). The 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).
Magnetic Resource 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.
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, fights disease and reduces inflammation.
Rebif(R) has been proven to slow the course of relapsing forms of multiple
sclerosis. In clinical studies, Rebif(R) 44 mcg administered three times a week
by subcutaneous injection has been shown to slow progression of disability and
reduce the frequency of relapses in relapsing-remitting MS. Additionally, use of
Rebif(R) was shown to statistically significantly reduce the number of active
brain
lesions and T2 lesion area as measured on MRI. The exact relationship between
MRI findings and clinical status of patients is unknown.
People living 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) at 1-877-44REBIF. Patients
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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. Compared to Avonex(R),
adverse reactions were similar - despite Rebif(R) being administered at higher
and more frequent doses(2). Exceptions included injection site disorders,
hepatic function disorders, white blood cell abnormalities, abdominal pain and
depression, which were more frequent with Rebif(R). Patients, especially those
with depression, seizure disorders, or liver problems, should discuss with their
doctors whether Rebif(R) is right for them.
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 worldwide 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 US.) 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 is committed to helping people living with MS as well as the MS
community. The Company has conducted leading research and product development in
the area of multiple sclerosis and other diseases. Serono's growing portfolio of
MS products is used to treat both relapsing forms of MS and worsening MS.
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 $1.546 billion, and a net income
of $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
products.
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(2) Data on file. Amendment to BLA File, Study 21125. Serono, Inc.; 2002.
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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 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.
FOR MORE INFORMATION, PLEASE CONTACT:
MEDIA RELATIONS MEDIA RELATIONS
SERONO, INC. PFIZER INC.
ROCKLAND, MA NEW YORK, NY
Tel: 781-681-2340 Tel: 212-733-4889
Fax: 781-681-2935 Fax: 212-808-8799
www.seronousa.com www.pfizer.com
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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)
May 22, 2003 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer