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 March, 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-______)
[GRAPHIC OMITTED]
serono
Media Release
FOR IMMEDIATE RELEASE
---------------------
PHASE III RAPTIVA(TM) STUDY RESULTS IN THE TREATMENT OF PSORIASIS PRESENTED AT
ANNUAL AAD MEETING
GENEVA, SWITZERLAND - MARCH 21, 2003 - SERONO S.A. (virt-x: SEO and NYSE: SRA)
Serono today announced positive results from a randomized Phase III clinical
trial with Raptiva(TM) (efalizumab) that studied efficacy and safety in the
treatment of adults with moderate-to-severe plaque psoriasis. The study results
were presented by Kenneth Gordon, M.D., Associate Professor of Medicine,
Division of Dermatology at Loyola University in Chicago, Illinois during a
session on emerging biologic therapies for psoriasis at the 61st annual American
Academy of Dermatology (AAD) meeting in San Francisco.
Results from the 556-patient, placebo-controlled study were consistent with data
obtained from previous Phase III Raptiva studies and were included as part of a
Marketing Authorization Application (MAA) in February 2003 to the European
Agency for the Evaluation of Medicinal Products (EMEA) and are currently under
review.
After 12 weeks of Raptiva therapy, 27 percent (98/369) of study patients
demonstrated 75 percent or greater Psoriasis Area and Severity Index (PASI)
score improvement, versus 4 percent (8/187) of patients on placebo, and 59
percent (216/369) achieved 50 percent or greater PASI score improvement, versus
14 percent (26/187) in the placebo group.
"The three large Phase III trials and a long-term open label trial demonstrate
clinically meaningful response in a majority of patients," said Andrew Galazka,
M.D., Serono's Senior Vice President Scientific Affairs. "We believe that these
efficacy results together with Raptiva's rapid onset of action and its safety
profile in more than 2,100 Raptiva-treated patients, means that Raptiva has
significant potential as a once-weekly treatment for moderate-to-severe
psoriasis."
Data from 15 months of an open-label multicenter trial evaluating the safety and
tolerability of Raptiva as a potential continuous treatment in patients with
moderate-to-severe psoriasis will be presented by Alice Gottlieb, M.D., director
of the Clinical Research Center at the Robert Wood Johnson Medical School at the
University of Medicine and Dentistry of New Jersey on Saturday, March 22.
-more-
EFFICACY AND QUALITY OF LIFE DATA PRESENTED
In the double blind, placebo-controlled, multicenter study, 556 patients were
randomized in a 2 to 1 ratio to receive weekly subcutaneous doses of 1 mg/kg
Raptiva (n=369) or placebo (n=187) for a 12-week period. The study's primary
endpoint was to compare the percentage of patients who achieved 75 percent or
greater improvement in PASI scores (PASI 75) after 12 weeks of Raptiva therapy
with patients receiving placebo. Secondary endpoints include the percentage of
patients who achieved 50 percent or greater improvement in PASI scores (PASI
50); the Overall Lesion Severity scale (OLS), which is a static measure of
global physician assessment on psoriasis; patient-reported outcomes such as the
Dermatology Life Quality Index (DLQI), which measures impairment from a skin
condition, and the Psoriasis Symptom Assessment (PSA).
At week 12, mean improvement in DLQI scores with Raptiva treatment was 47
percent, versus 14 percent for patients on placebo. The study results with
Raptiva showed improvement on each of the eight PSA subsets: pain, burning or
stinging, itching, bothered by water, irritation, sensitivity, bleeding and
scaling.
"The reduction in disease severity and rapid onset of action observed in
Raptiva-treated study patients along with the positive impact on these patients'
quality of life measurements provide further support for Raptiva as a potential
treatment option for psoriasis patients," said Dr. Gordon.
The most common adverse events in patients receiving Raptiva compared with those
in the placebo group included headache, chills, pain, fever, and myalgia (muscle
pain). These events occurred principally following the first two injections of
Raptiva. For the third and subsequent doses, the incidence of acute adverse
events was similar between the Raptiva and placebo groups. The only serious
unexpected adverse event reported as study drug related by the investigators was
one case of myelitis.
ABOUT RAPTIVA(TM)
As a targeted T-cell modulator, Raptiva (efalizumab) is designed to block the
activation of T-cells that cause psoriasis, without destroying them. Raptiva
has been studied as a once-weekly therapy for the continuous treatment of
moderate-to-severe plaque psoriasis. In clinical trials, Raptiva was
administered via subcutaneous injection and in several of the trials was
self-administered by some patients in their homes.
Raptiva(TM), a recombinant humanized monoclonal antibody, is designed to inhibit
the adhesion of T-lymphocytes to other cell types by inhibiting the binding of
LFA-1 to ICAM-1. This mechanism of action has a number of effects depending upon
the cell type, which include: (1) inhibition of T-lymphocyte interactions with
tissue-specific cells, (2) inhibition of T-lymphocyte migration, (3) inhibition
of T-lymphocyte activation, proliferation and cytokine release. In the clinical
Phase III studies, Raptiva(TM) was given as a once-a-week subcutaneous
injection. Raptiva(TM) is potentially the first and only once-a-week
subcutaneous treatment for psoriasis. Raptiva(TM) is currently in Phase II
trials in Rheumatoid Arthritis and is being also evaluated for the treatment of
Psoriatic Arthritis.
-more-
Serono has the rights to develop and market Raptiva(TM) worldwide outside of the
United States and Japan. Development and marketing rights in the United States
remain with Genentech Inc. (NYSE:DNA) and its U.S. partner XOMA (Nasdaq: XOMA),
who filed a Biologics License Application (BLA) with the FDA in December 2002.
ABOUT PSORIASIS
Psoriasis is a chronic skin disease that affects approximately 5.7 million
Europeans. Psoriasis occurs when new skin cells grow abnormally, resulting in
thick, red, scaly, inflamed patches. Plaque psoriasis, the most common form of
the disease, is characterized by inflamed patches of skin ("lesions") topped
with silvery white scales. Psoriasis can be limited to a few spots or involve
extensive areas of the body, appearing most commonly on the scalp, knees, elbows
and trunk. Although it is highly visible, psoriasis is not a contagious disease.
While there are a number of medications that may help control the symptoms of
psoriasis, there currently is no known cure.
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).
###
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 May 21 2002. 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.
###
-more-
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
------------------------
GENENTECH:
MEDIA CONTACT:
Tara Cooper: +1 (650) 225-5505
INVESTOR CONTACT:
Kathee Littrell: +1 (650) 225-1034
www.gene.com
------------
-end-
[GRAPHIC OMITTED]
Serono
Media Release
FOR IMMEDIATE RELEASE
-----------------------
PRELIMINARY RESULTS FROM OPEN-LABEL RAPTIVA(TM) STUDY SUGGEST CONTINUED BENEFIT
WITH LONG-TERM TREATMENT
OVER 64 PERCENT OF PATIENTS CONTINUING TREATMENT FOR 15 MONTHS SHOWED PASI 75
OR GREATER RESPONSE WITH WEEKLY RAPTIVA THERAPY
GENEVA, SWITZERLAND - MARCH 24, 2003 - Serono S.A. (virt-x: SEO and NYSE: SRA)
Serono today announced preliminary results from an open-label, multicenter trial
evaluating the long-term safety and tolerability of continuous Raptiva(TM)
(efalizumab) treatment in patients with moderate-to-severe psoriasis.
"The findings from this important open label study on the long-term safety and
efficacy of Raptiva are very encouraging and further support Raptiva's potential
to address the unmet medical need of patients with moderate-to-severe
psoriasis", said Andrew Galazka, M.D., Serono's Senior Vice President Scientific
Affairs.
Alice Gottlieb, M.D., director of the Clinical Research Center at the Robert
Wood Johnson Medical School at the University of Medicine and Dentistry of New
Jersey presented data for patients receiving continuous Raptiva treatment for
one-year following an initial three months of treatment. The data were presented
on Saturday, March 22 at the 61st annual American Academy of Dermatology meeting
being held in San Francisco.
RESPONSE RATES WITH CONTINUED RAPTIVA TREATMENT
A total of 339 patients were enrolled in this continuing open-label, multicenter
study. 41 percent of patients (140/339) achieved 75 percent or greater
improvement in Psoriasis Area and Severity Index (PASI) scores (PASI 75) and 82
percent (278/339) achieved PASI 50 or greater improvement after 12 weeks of 2
mg/kg/week Raptiva therapy. Patients who achieved PASI 50 or OLS (Overall Lesion
Severity scale) of clear, minimal or mild at week 12 were eligible to enter the
continuous treatment period. Of the original 339 patients, 290 patients who met
the entry criteria for the maintenance period entered the continuous treatment
phase of the study. For each successive three-month period of treatment,
dropouts during that cohort period were counted as non-responders for that
cohort, but were excluded from the subsequent cohorts.
-more-
Starting from week 13, the weekly subcutaneous doses in patients were reduced to
1 mg/kg Raptiva. At weeks 13-24 (n=290) more than 77 percent of patients who
continued on therapy achieved PASI 50 and more than 51 percent achieved PASI 75.
Of which, more than 22 percent of patients achieved PASI 90. At weeks 49-60
(n=228), more than 79 percent of patients who continued on therapy achieved PASI
50 and over 64 percent achieved PASI 75. Of which, more than 31 percent
achieved PASI 90.
"The data from this study suggest that for some patients, Raptiva may present an
option for continuous treatment of moderate-to-severe psoriasis," said Dr.
Gottlieb. "As a chronic disease, the opportunity for an efficacious treatment
with a favorable safety profile is of interest to clinicians as we explore
potential therapies for this devastating disease."
The most common adverse events during the first 12 weeks of treatment were
headache, non-specific infection (e.g., common colds), chills, pain, nausea,
asthenia (weakness), and fever. These events principally occurred following the
first two injections of Raptiva. No new adverse events emerged during continuous
Raptiva therapy. Over time, among those patients who continued on therapy, the
percentage of patients who experienced at least one adverse event decreased from
57 percent during weeks 13-24 to 47 percent during weeks 49-60. The occurrence
of serious adverse events during the 15 months of treatment was infrequent,
which is consistent with data from previous Raptiva Phase III studies.
ABOUT RAPTIVA(TM)
In February 2003, Serono filed a Marketing Authorization Application (MAA) to
the European Agency for the Evaluation of Medicinal Products (EMEA) for
Raptiva(TM) (efalizumab) for the treatment of adult patients with
moderate-to-severe plaque psoriasis. The MAA submission included data from over
2,100 patients with moderate-to-severe plaque psoriasis treated with Raptiva.
Serono has the rights to develop and market Raptiva(TM) worldwide outside of the
United States and Japan. Development and marketing rights in the United States
remain with Genentech Inc. (NYSE:DNA) and its U.S. partner XOMA (Nasdaq: XOMA),
who filed a Biologics License Application (BLA) with the FDA in December 2002.
As a targeted T-cell modulator, Raptiva is designed to block the activation of
T-cells that cause psoriasis, without destroying them. Raptiva has been studied
as a once-weekly therapy for the continuous treatment of moderate-to-severe
plaque psoriasis. In clinical trials, Raptiva was administered via subcutaneous
injection and in several of the trials was self-administered by some patients in
their homes.
Raptiva(TM), a recombinant humanized monoclonal antibody, is designed to inhibit
the adhesion of T-lymphocytes to other cell types by inhibiting the binding of
LFA-1 to ICAM-1. This mechanism of action has a number of effects depending upon
the cell type, which include: (1) inhibition of T-lymphocyte interactions with
tissue-specific cells, (2) inhibition of T-lymphocyte migration, (3) inhibition
of T-lymphocyte activation, proliferation and cytokine release. In the clinical
Phase III studies, Raptiva(TM) was given as a once-a-week subcutaneous
injection. Raptiva(TM) is potentially the first and only once-a-week
subcutaneous treatment for psoriasis. Raptiva(TM) is currently in Phase II
trials in Rheumatoid Arthritis and is being also evaluated for the treatment of
Psoriatic Arthritis.
-more-
ABOUT PSORIASIS
Psoriasis is a chronic skin disease that affects approximately 5.7 million
Europeans. Psoriasis occurs when new skin cells grow abnormally, resulting in
thick, red, scaly, inflamed patches. Plaque psoriasis, the most common form of
the disease, is characterized by inflamed patches of skin ("lesions") topped
with silvery white scales. Psoriasis can be limited to a few spots or involve
extensive areas of the body, appearing most commonly on the scalp, knees, elbows
and trunk. Although it is highly visible, psoriasis is not a contagious disease.
While there are a number of medications that may help control the symptoms of
psoriasis, there currently is no known cure.
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).
###
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 May 21 2002. 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.
###
-more-
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
------------------------
GENENTECH:
MEDIA CONTACT:
Tara Cooper: +1 (650) 225-5505
INVESTOR CONTACT:
Kathee Littrell: +1 (650) 225-1034
www.gene.com
------------
-end-
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)
March 24, 2003 By: /s/ Allan Shaw
-------------------
Name: Allan Shaw
Title: Chief Financial Officer