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 July 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, July 14, 2003
New Major Results on ARIXTRA(R) presented
at the International Society on Thrombosis and Haemostasis (ISTH):
ARTEMIS and PEGASUS trials
ARTEMIS shows that ARIXTRA(R) significantly lowers the risk of venous
thromboembolism in acutely ill medical patients
PEGASUS shows that ARIXTRA(R) provides benefit in preventing venous
thromboembolism in patients undergoing major abdominal surgery
The results of two major trials on Arixtra(R) (fondaparinux sodium) - ARTEMIS
and PEGASUS - were presented today at the 19th Congress of the International
Society on Thrombosis and Haemostasis (ISTH) in Birmingham, UK.
Here is a brief overview of the results.
ARTEMIS results
---------------
The results of the ARixtra(R) for ThromboEmbolism prevention in a Medical
Indications Study (ARTEMIS) presented today demonstrate that the use of
Arixtra(R) 2.5 mg administered once daily significantly reduces the risk of
venous thromboembolism (VTE) in acutely ill hospitalised medical patients from
10.5% in the control group to 5.6% in the Arixtra(R) group (odds reduction =
49.5 % - p=0.029). There was a low rate of major bleeding (0.2%) in this
population with Arixtra(R). Arixtra(R) therapy also showed a trend in reducing
overall mortality patients, from 6.0% in the control group to 3.3% in the
Arixtra(R) group, as assessed at day 32.
Regulatory submissions for this new indication should occur at the end of 2003
or beginning of 2004.
PEGASUS results
---------------
The results of the PEntasaccharide in GenerAl SUrgery Study (PEGASUS) presented
today demonstrate that Arixtra(R) has at least comparable efficacy and safety
than the low-molecular-weight heparin (LMWH) dalteparin for the prevention of
venous thromboembolism (VTE) following major abdominal surgery. The PEGASUS
study showed that the incidence of VTE was 4.6% in the Arixtra(R) group and 6.1%
in the control group (p=0.14), with a trend in favor of Arixtra(R). Among
patients undergoing abdominal cancer surgery, which represented around 70% of
the overall study population, the incidence of VTE was significantly reduced in
the Arixtra(R) group (4.7%) compared with the control group (7.7%) (p=0.02).
This improved efficacy was achieved with comparable safety. Major bleeding rate
was similar in both groups.
Regulatory submissions for this new indication should occur at the end of 2003
or beginning of 2004. These two new targeted indication as well as the treatment
of VTE indication should allow Arixtra(R) to get access to 80 % of the current
LMWH market - in number of patients - versus only 15% today.
ADDITIONAL INFORMATION
----------------------
Arixtra(R) was launched in the United States on February 8, 2002, and in Europe
as from March 27, 2002.
Prophylaxis of VTE
Arixtra(R) 2.5 mg has been extensively investigated in prophylaxis of VTE
following major orthopedic surgery. In four phase III trials performed in
patients undergoing hip fracture, hip or knee replacement surgery, Arixtra(R)
more than halved the incidence of VTE (relative risk reduction of more than 55%
- p < 0.001) with a similar safety profile compared to enoxaparin across all
surgery types.
Extended prophylaxis of VTE
A recent trial in extended prophylaxis in hip fracture patients (PENTHIFRA-PLUS)
found that Arixtra(R) administered for four weeks compared to one week markedly
reduces the incidence of further VTE complications by 96% (p < 0.001) and
reduced the rate of symptomatic VTE to 0.3%. This trial allowed Arixtra(R) to be
granted a new indication in the United States in June 2003 : "Prophylaxis of
deep venous thrombosis, which may lead to pulmonary embolism, in patients
undergoing hip fracture surgery, including extended prophylaxis". The file for
this new indication in Europe was submitted to the EMEA in December 2002 and is
currently under review.
Treatment of VTE
In December 2002, the results of the MATISSE program represented another step
forward in the demonstration of the efficacy and safety of Arixtra(R). The key
findings of the MATISSE program were that a fixed 7.5 mg once-daily subcutaneous
dose of Arixtra(R) was at least comparable in efficacy and safety as current
therapy. As an added benefit to physicians and patients, Arixtra(R) is more
convenient to use in the initial treatment of DVT and PE. Regulatory submissions
for this new indication and dosage forms should occur in the 3rd quarter of
2003.
Treatment of patients with acute coronary syndrome
Further clinical investigations are being carried out to extend the use of
Arixtra(R) for the treatment of patients with acute coronary syndrome.
The life cycle management program on Arixtra(R) is going on according to plan.
As with other antithrombotics, the most common side effect during Arixtra(R)
administration is bleeding. Arixtra(R) is contraindicated in patients with
severely impaired kidney function or in patients who weigh less than 50 kg (110
pounds), because they may have an increased risk for major bleeding. Patients
greater than 75 years of age also may be more likely to experience major
bleeding complications. As with other antithrombotics, labeling for Arixtra(R)
includes a Boxed Warning regarding possible spinal/epidural haematomas when
spinal anaesthesia or spinal puncture is used.
Please refer to the approved Package Insert for the indication and safety
profile.
Arixtra(R) is the first totally synthetic agent to selectively inhibit a
specific key enzyme in the coagulation process called Factor Xa (<>a).
Other therapies such as Low Molecular Weight Heparin (LMWH) and Unfractionated
Heparin (UFH) are from animal origin (extracted mainly from porcine intestine
mucosa) and have multitargeted activity on the clotting cascade.
Arixtra(R) was discovered and is being co-developed by Sanofi-Synthelabo and
Organon.
With this synthetic drug, Sanofi-Synthelabo and Organon intends to establish
Arixtra(R) as a reference treatment in the antithrombotic field.
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
Investor Relations Department:
Philippe Goupit Director of Investor Relations
Isabelle Laurent Investor Relations
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
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: July 15, 2003
SANOFI-SYNTHELABO
By: /s/ Marie-Helene Laimay
-----------------------
Name: Marie-Helene Laimay
Title: Senior Vice President and
Chief Financial Officer