SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULES 13a-16 OR 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the Month of June 2003
SANOFI-SYNTHELABO
(Exact name of registrant as specified in its charter)
174, avenue de France, 75013 Paris, FRANCE
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual
reports under cover 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-_______________.
Sanofi~Synthelabo logo
Investor Relations
Paris, June 2, 2003
Major Results on oxaliplatin presented at the
American Society of Clinical Oncology (ASCO).
Oxaliplatin clearly demonstrates consistent superiority
in the treatment of colorectal cancer in all settings of the disease:
from early stage, adjuvant treatment after surgery, to the metastatic setting.
Sanofi-Synthelabo announced today major results on oxaliplatin presented at the
39th annual meeting of the American Society of Clinical Oncology (ASCO).
136 abstracts on oxaliplatin were published at the meeting and important new
data were presented: from early stage of the disease, adjuvant treatment
following surgery, to metastatic setting, 1st and 2nd /3rd line treatment. These
results show that oxaliplatin is effective in all stages of the disease and
hence significantly improve the quality and length of life for colorectal cancer
patients.
In early stage:
- Results from the MOSAIC trial for the use oxaliplatin as adjuvant
therapy following surgery, presented by A. de Gramont
In metastatic setting:
- Results from an NCI-sponsored 1st-line colorectal cancer trial - N 9741
- presented by R. Goldberg
- Results from a 2nd-line colorectal cancer trial - EFC 4584 -
presented by M. Rothenberg
- Results from a 3rd-line colorectal cancer trial - EFC 4760 -
presented by N. Kemeny
Here is a brief overview of the results:
MOSAIC study (adjuvant therapy)
Efficacy results of the MOSAIC study demonstrated that the addition of
oxaliplatin to the current post surgery standard chemotherapy,
5-Fluorouracil/Leucovorin (5-FU/LV), for colon cancer reduces the risk of
recurrence by 23% vs. current standard treatment alone. This strong achievement,
15 years after 5-FU/LV was established as standard adjuvant treatment, is a
major step towards curing more patients and was obtained without dramatically
impacting safety.
N 9741 study (1st line treatment for metastatic colorectal cancer)
The results of this NCI-sponsored trial clearly show the superiority of the
FOLFOX regimen (oxaliplatin + 5-FU/LV) versus the IFL regimen (irinotecan +
5-FU/LV), in terms of response rate (RR), progression free survival (PFS),
overall survival (OS) and safety profile. The overall survival was 19.5 months
with the FOLFOX regimen versus 14.8 months with the IFL regimen (p = 0.0001)
giving an improvement of 4.7 months in favor of oxaliplatin-based treatment,
representing a survival gain of more than 30%.
EFC 4584 study (2nd line treatment for metastatic colorectal cancer)
The study compared the FOLFOX regimen versus 5-FU/LV, as 2nd line treatment for
metastatic colorectal cancer, after IFL regimen failure. The response rate and
the progression free survival were significantly superior in the FOLFOX group.
The overall survival was 9.8 months in the FOLFOX group versus 8.7 months in the
5-FU/LV group (p=0.07), clearly suggesting a trend for survival improvement, in
this very difficult-to-treat patient population for which no viable option is
available.
In addition, this study clearly shows a superiority of oxaliplatin as far as
clinical benefit is concerned as demonstrated by the significant improvement of
disease-related symptoms.
With these very promising results, Sanofi-Synthelabo should file oxaliplatin in
the United States, for the 1st line treatment for metastatic colorectal cancer
(MCRC) in the early second half of the year 2003 and for the adjuvant treatment
of colorectal cancer towards the end of the year 2003. The filing in Europe for
the adjuvant treatment of colorectal cancer should occur in the second half of
the year 2003.
In the US, ELOXATIN(R) (oxaliplatin for injection) is approved for use in
combination with infusional 5-fluorouracil (5-FU) and leucovorin (LV), is
currently indicated for the treatment of patients with metastatic carcinoma of
the colon or rectum whose disease has recurred or progressed during or within
six months of completion of first-line therapy with the combination of bolus
5-FU/LV and irinotecan. The approval of ELOXATIN(R) was based on the response
rate and time to tumor progression observed in an ongoing trial. Data that
demonstrate a clinical benefit, such as improvement of disease-related symptoms
or increased survival were not available at approval.
ELOXATIN(R) (oxaliplatin for injection) is a chemotherapeutic cancer agent and
as such should be administered under the supervision of a qualified physician
experienced in the use of such products.
ELOXATIN(R) should not be administered to patients with a history of known
allergy to ELOXATIN(R) or other platinum compounds. Women of childbearing
potential should be advised not to become pregnant while receiving treatment
with ELOXATIN(R). As with other platinum compounds, hypersensitivity and
anaphylactic/anaphylactoid reactions have been reported. ELOXATIN(R) is
associated with pulmonary toxicity, which may be fatal and two distinct types of
primarily peripheral sensory neuropathies: an acute, reversible type of early
onset and a persistent type (>14 days). An acute syndrome of pharyngolaryngeal
dysesthesia seen in 1-2% of patients characterized by subjective sensations of
dysphagia or dyspnea, without any laryngospasm or bronchospasm (no stridor or
wheezing) may also occur.
Both 5-FU and ELOXATIN(R) are associated with gastrointestinal and hematologic
adverse events. When ELOXATIN(R) is administered in combination with 5-FU, the
incidence of these events is increased. The most frequently reported adverse
events with ELOXATIN(R) in combination with infusional 5-FU/LV are acute
neuropathy (56%), persistent neuropathy (48%), fatigue (68%), diarrhea (67%),
nausea (65%) and vomiting (40%). Changes in hematology parameters were also
seen: anemia (81%), leukopenia (76%), neutropenia (73%), and thrombocytopenia
(64%).
Full prescribing information including boxed warning is available through
www.eloxatin.com.
About one million new cases of colorectal cancer are diagnosed worldwide, and
about 150,000 new cases in the U.S. According to the American Cancer Society,
colorectal cancer is the second leading cause of malignancy-related death in the
U.S., accounting for 10 to 15% of all cancer death. Over a lifetime, about one
in 18 people develop colorectal cancer, and, each year, about 56,000 people die
from it in the U.S.
ELOXATIN(R)is currently marketed by Sanofi-Synthelabo in more than 60 countries
for 1st and/or 2nd line metastatic colorectal cancer and is undergoing extensive
worldwide clinical development for new indications. Global sales of ELOXATIN(R)
reached EUR 389 million in 2002. Sales for the first quarter 2003 were EUR 185
million. Oxaliplatin was developed in association with Debiopharm S.A.
About Sanofi-Synthelabo
Sanofi-Synthelabo is a major global research-based pharmaceutical group with
32,500 employees in more than 100 countries. The company is headquartered in
Paris and listed in Paris (Euronext: SAN) and in New York (NYSE: SNY). With
consolidated sales of EUR 7.4 billion in 2002, Sanofi-Synthelabo ranks 7th in
Europe and among the world's top 20 pharmaceutical companies. With an R&D
portfolio of 52 compounds in development, Sanofi-Synthelabo is focused on a core
group of four therapeutic areas: cardiovascular disease and thrombosis; diseases
of the central nervous system; internal medicine; and oncology.
Forward Looking Statement
This release contains statements that constitute forward-looking statements
within the meaning of the U.S. Private Securities Litigation Reform Act of 1995.
These statements are based on management's current expectations or beliefs and
are subject to a number of factors and uncertainties that could cause actual
results to differ materially from those described in the forward-looking
statements. The following factors, among others, could cause actual results to
differ materially from those described in the forward-looking statements: the
ability of Sanofi-Synthelabo to expand its presence profitably in the United
States; the success of Sanofi-Synthelabo's research and development programs;
the ability of Sanofi-Synthelabo to protect its intellectual property rights;
and the risks associated with reimbursement of health care costs and pricing
reforms, particularly in the United States and France.
Investors and security holders may obtain a free copy of documents filed by
Sanofi-Synthelabo with the U.S. Securities and Exchange Commission at
www.sec.gov or directly from Sanofi-Synthelabo on the web site www.
sanofi-synthelabo.com
Conference Call
To discuss the data presented at the at the American Society of Clinical
Oncology (ASCO), a conference call has been organised on Monday, June 2nd 2003
at 3:00 pm (Paris time).
The conference call will be chaired by:
Dr. Alain HERRERA, Vice President,
Oncology Franchise of Sanofi-Synthelabo,
In order to participate in the conference call, please dial the following
numbers 10 minutes before it starts:
France: 00 33 (0) 1 70 70 81 99 code: 420295
United Kingdom: 00 44 (0) 207 984 75 76 code: 420295
USA: 00 1 719 457 26 37 code: 598646
A recorded version of the conference will be made available through Friday June
13th, 2003 by dialing:
France: 00 33 (0) 1 70 70 82 10 code: 420295#
United Kingdom: 00 44 (0) 207 784 10 24 code: 420295#
USA: 00 1 719 457 08 20 code: 420295#
Investor Relations Department
Philippe Goupit Director of Investor Relations
Isabelle Laurent Investor Relations Europe
Arnaud Delepine Investor Relations Europe
Sanjay Gupta Investor Relations US
Contacts:
E-mail: investor-relations@sanofi-synthelabo.com
Europe US
Tel: + 33 1 53 77 45 45 Tel.: 1 212 551 42 93
Fax: + 33 1 53 77 42 96 Fax: 1 212 551 49 10
Sanofi~Synthelabo logo
Investor Relations
Paris, June 2, 2003
Major Results on Eloxatin(R) presented
at the American Society of Clinical Oncology (ASCO).
CONFERENCE CALL
To discuss the data presented at the American Society of Clinical Oncology
(ASCO), a conference call has been organized on:
Monday, June 2nd 2003 at 3:00 pm (Paris time).
The conference call will be chaired by:
Dr. Alain HERRERA, Vice President,
Oncology Franchise of Sanofi-Synthelabo,
In order to participate in the conference call, please dial the following
numbers 10 minutes before it starts:
France: 00 33 (0) 1 70 70 81 99 code: 420295
United Kingdom: 00 44 (0) 207 984 75 76 code: 420295
USA: 00 1 719 457 26 37 code: 598646
A recorded version of the conference will be made available through Friday June
13th, 2003 by dialing:
France: 00 33 (0) 1 70 70 82 10 code: 420295#
United Kingdom: 00 44 (0) 207 784 10 24 code: 420295#
USA: 00 1 719 457 08 20 code: 420295#
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.
Dated: June 2, 2003
SANOFI-SYNTHELABO
By: /s/ Marie-Helene Laimay
-----------------------------
Name: Marie-Helene Laimay
Title: Senior Vice President and
Chief Financial Officer