Sanofi – ‘6-K’ for 11/19/02

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Report of a Foreign Private Issuer   —   Form 6-K
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 6-K         Report of a Foreign Private Issuer                     4     20K 

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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 November 2002
 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 
             ---             ---

  (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-_______________.

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Sanofi~Synthelabo logo                                 Bristol-Myers Squibb logo

An agreement between Bristol-Meyers Squibb and Sanofi-Synthelabo for the        
codevelopment and marketing of irbesartan and clopidogrel, two compounds from   
Sanofi-Synthelabo research.                                                     

LONG-TERM TREATMENT FOR ONE YEAR WITH CLOPIDOGREL (PLAVIX(R)/ISCOVER(R)) AND
ASPIRIN SIGNIFICANTLY REDUCES THE RISK OF DEATH, HEART ATTACK AND STROKE
IN MAJOR NEW STUDY
 CREDO Study Results Announced Today at the American Heart Association Meeting

[Chicago, IL, November 18, 2002] - The results of a landmark clinical study     
demonstrate that patients who undergo a percutaneous coronary intervention      
(PCI), such as angioplasty (with or without stent) can significantly reduce     
their risk of death, heart attack, or stroke by continuing treatment long-term  
(one year) with the antiplatelet agent clopidogrel (Plavix(R), Iscover(R))(1)   
and aspirin. The results of the study, entitled Clopidogrel for Reduction of    
Events During Observation (CREDO), demonstrate that long-term clopidogrel       
(Plavix(R), Iscover(R)) and aspirin treatment produced a 27 percent reduction in
the risk of death, heart attack or stroke (p=0.02) compared to aspirin          
treatment. These results were presented today at the American Heart Association 
Scientific Sessions 2002 in Chicago.                                            

"The CREDO study has important implications since it is the first randomized    
study to have studied clopidogrel in PCI patients for one year," said Steven    
Steinhubl, M.D., Associate Professor of Medicine at the University of North     
Carolina at Chapel Hill and the CREDO study lead investigator. "CREDO confirms  
that clopidogrel (Plavix(R), Iscover(R)) has a significant effect on PCI        
patients by reducing their risk of death, heart attack and stroke." In the U.S. 
approximately 850,000 patients undergo PCI procedures each year.                

CREDO CLINICAL STUDY                                                            
CREDO was a double-blind, randomized study including 2,116 patients, which was  
carried out in 99 centers, 88 in the United States and 11 in Canada. The study  
was designed to evaluate the efficacy and safety of long-term treatment with    
clopidogrel (Plavix(R), Iscover(R)) and the effect of pre-treatment with a      
clopidogrel loading dose three to 24 hours before PCI. Following randomization, 
patients received either a 300 mg loading dose of clopidogrel or placebo, and   
then during the 28 days following PCI, all patients in the study received 75 mg 
clopidogrel and 325 mg aspirin once daily in addition to other standard         
therapies. For the remaining 11 months of the study, patients either received 75
mg clopidogrel or placebo once a day, both in addition to aspirin (81-325       
mg/day) and other standard therapies. The primary endpoint at 28 days was the   
composite of death, heart attack or urgent target vessel revascularization      
(UTVR). The principal one year endpoint was the composite of death, heart attack
or stroke.                                                                      

Patients who were treated with a loading dose of clopidogrel (3-24 hours prior  
to PCI) showed an 18.5 percent relative risk reduction (p=0.23) in death, heart 
attack or UTVR at 28 days. When patients received the loading dose at least six 
hours prior to PCI, the relative risk reduction was increased to 39 percent     
(p=0.05).                                                                       

The CREDO study results demonstrate the benefits of long-term (one year)        
administration of clopidogrel (Plavix(R), Iscover(R)) plus aspirin versus       
placebo plus aspirin in patients undergoing PCI. From randomization to the end  
of long-term treatment, the clopidogrel (Plavix(R), Iscover(R)) treated group   
demonstrated a statistically significant 27 percent reduction in the relative   
risk of the combined endpoint of death, MI, or stroke (8.5 percent vs 11.5      
percent respectively, p=0.02). This benefit was consistent in all patient       
subgroups evaluated.                                                            

Patients in the study who received clopidogrel and aspirin for a year had no    
statistically significant increase in bleeding compared to patients receiving   
aspirin alone, although there was a trend towards an increase in major bleeding 
(8.8% clopidogrel plus aspirin versus 6.7% placebo plus aspirin, p=0.07). There 
were no fatal bleeds or intracranial hemorrhages.                               

"The CREDO study results demonstrate both the long-term efficacy and the safety 
of clopidogrel (Plavix(R), Iscover(R)) in this study population," said Eric     
Topol, M.D., Chairman of Cardiovascular Medicine at The Cleveland Clinic        
Foundation and Chairman of the Steering Committee of the CREDO study. "These    
data are consistent with the recent changes to the treatment guidelines which   
recommend the use of long-term oral antiplatelet therapy in the growing number  
of patients requiring PCI with or without stent. This data may encourage more   
physicians to apply the guidelines to their daily clinical practice."           

In 2002, the American College of Cardiology, the American Heart Association     
(ACC/AHA(2)) and the European Society of Cardiology (ESC(3)) updated their      
guidelines for treating patients with acute coronary syndrome (ACS - unstable   
angina and non-Q-wave MI) to reflect the clinical evidence regarding the        
benefits of clopidogrel (Plaxix(R), Iscover(R)) for patients with ACS. The      
guidelines now recommend that antiplatelet therapy (e.g. clopidogrel and        
aspirin) should be initiated early and continued long-term (ACC/AHA for at least
one month and up to 9 months, ESC at least 9 months) in patients undergoing PCI.
These recommendations were based on the results of the CURE (Clopidogrel in     
Unstable Angina to Prevent Recurrent Ischemic Events) study which was published 
in August 2001 in the New England Journal of Medicine.(4)                       

Clopidogrel was originally approved for marketing in the United States in       
November 1997 under the name PLAVIX(R) and in Europe in July 1998 under the     
names PLAVIX(R) and Iscover(R) based on the pivotal 19,185 patient CAPRIE       
(Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events) study.      
Clopidogrel is currently undergoing one of the largest international clinical   
development programs: in cardiology (the COMMIT and CLARITY studies in patients 
with acute myocardial infarction), in neurology (the MATCH study), in patients  
at high risk of atherothrombotic events (the CHARISMA study), in patients with  
atrial fibrillation (the ACTIVE study) and in patients with peripheral arterial 
disease (the CASPAR and CAMPER studies). These studies will include more than   
80,000 patients worldwide.                                                      

To date, more than 15 million patients worldwide have been treated with         
clopidogrel (Plavix(R), Iscover(R)).                                            

U.S. INDICATION                                                                 
Clopidogrel is marketed in the United States by Sanofi-Synthelabo               
(Euronext:SAN/NYSE:SNY) and Bristol-Myers Squibb (NYSE:BMY) under the name      
PLAVIX(R) for the reduction of thrombotic events as follows: For patients with a
history of recent myocardial infarction (MI), recent stroke, or established     
peripheral arterial disease, PLAVIX(R) has been shown to reduce the rate of a   
combined end point of new ischemic stroke (fatal or not), new MI (fatal or not),
and other vascular death. For patients with acute coronary syndrome (unstable   
angina/non-Q-wave MI), including patients who are to be managed medically and   
those who are to be managed with percutaneous coronary intervention (with or    
without stent) or CABG, PLAVIX(R) has been shown to decrease the rate of a      
combined end point of cardiovascular death, MI, or stroke as well as the rate of
a combined end point of cardiovascular death, MI, stroke, or refractory         
ischemia.                                                                       

IMPORTANT CLINICAL CONSIDERATIONS                                               
Clopidogrel (Plavix(R), Iscover(R)) is contraindicated in patients with active  
pathological bleeding such as peptic ulcer or intracranial hemorrhage. As with  
other antiplatelet agents, Plavix(R)/Iscover(R) should be used with caution in  
patients who may be at risk of increased bleeding from trauma, surgery, or      
coadministration with NSAIDs or warfarin. (See CONTRAINDICATIONS and            
PRECAUTIONS.*)                                                                  

The rates of major and minor bleeding were higher in patients treated with      
Plavix(R)/Iscover(R) plus aspirin compared with placebo plus aspirin in a       
clinical trial. (See ADVERSE REACTIONS.*)                                       

As part of the worldwide postmarketing experience with Plavix(R)/Iscover(R),    
suspected cases of thrombotic thrombocytopenic purpura (TTP) have been reported 
at a rate of about 4 cases per million patients exposed. TTP has been reported  
rarely following use of Plavix(R), Iscover(R), sometimes after short exposure   
(<2 weeks).                                                                     
TTP is a serious condition requiring prompt treatment. (See WARNINGS.*)         
In clinical trials, the most common clinically important side effects were      
pruritus, purpura, diarrhea, and rash; infrequent events included intracranial  
hemorrhage (0.4%) and severe neutropenia (0.05%). (See ADVERSE REACTIONS.*)     

* Please see full prescribing information for clopidogrel, available by         
contacting Sanofi-Synthelabo or Bristol-Myers Squibb, or on the Internet at     
www.Plavix.com.                                                                 

EUROPEAN INDICATION                                                             
Clopidogrel is marketed in Europe by Sanofi-Synthelabo (Euronext:SAN/NYSE:SNY)  
and Bristol-Myers Squibb (NYSE:BMY) under the names Plavix(R) and Iscover(R) for
the prevention of atherothrombotic events (heart attack, stroke or death from a 
cardiovascular cause) in patients suffering from myocardial infarction (from a  
few days until less than 35 days), ischemic stroke (from seven days until less  
than six months) or established peripheral arterial disease. In September 2002, 
the European Commission for the European Union approved an additional indication
for the prevention of atherothrombotic events in for patients suffering from    
non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave 
myocardial infarction) in combination with ASA.                                 

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 the 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 and Bristol-Myers Squibb to expand their presence  
profitably in the United States; the success of their research and development  
programs; their ability to protect their intellectual property rights ; and the 
risks associated with reimbursement of healthcare costs and pricing reforms,    
particularly in the United States and France. Sanofi-Synthelabo and             
Bristol-Myers Squibb do not undertake any obligation to provide updates or to   
revise any forward-looking statements. Investors and security holders may obtain
a free copy of documents filed by Sanofi-Synthelabo and Bristol-Myers Squibb    
with the U.S. Securities and Exchange Commission at www.sec.gov or directly from
Sanofi-Synthelabo or Bristol-Myers Squibb.                                      

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References                                                                      
(1) PLAVIX(R)is marketed as Iscover(R)in some countries.                  
(2) ACC/AHA Guideline Update for the Management of Patients with Unstable 
    Angina and Non-ST-Segment Elevation Myocardial Infarction: A Report of
      the American College of Cardiology/American Heart Association Task Force
  on Practice Guidelines (Committee on the Management of Patients with
 Unstable Angina). Braunwald E. et al., Circulation October 1, 2002.
(3) Press Announcement of the European Society of Cardiology issued       
September 1st, 2002. European Society of Cardiology website       
(http://www.escardio.org.).                                       
(4) The CURE Trial Investigators. Effects of clopidogrel in addition to   
  aspirin in patients with acute coronary syndromes without ST-segment
elevation. N Engl J Med 2001; 345:494-502.                        

CONTACTS:                                                               

Investor Relations Department                                           
Philippe Goupit     Director of Investor Relations                      
Isabelle Laurent    Investor Relations Europe                           
Sanjay Gupta        Investor Relations US                               

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             

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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.                                         

Dated: November 19, 2002                                                        

                       SANOFI-SYNTHELABO

                                 By: /s/ Marie-Helene Laimay
                                               ---------------------------------
                                        Name:  Marie-Helene Laimay
                                               Title:  Senior Vice President and
                                                     Chief Financial Officer

Dates Referenced Herein

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