Discontinuation of One of the Studies (ANDROMEDA) With DRONEDARONE

Jan 17, 2003, 00:00 ET from Sanofi-Synthelabo

    PARIS, Jan. 17 /PRNewswire-FirstCall/ -- Sanofi-Synthelabo
 (EURONEXT: SNYNF, NYSE:   SNY) announced today that the company has decided to
 discontinue the ANDROMEDA study, after considering the recommendations of the
 Steering Committee and the independent Data Safety and Monitoring Board (DSMB)
 of this study.
     ANDROMEDA (Antiarrhythmic trial with Dronedarone in Moderate to severe CHF
 Evaluating morbidity Decrease) is a double blind, placebo-controlled study
 evaluating dronedarone in high risk patients with congestive heart failure and
 ventricular dysfunction.  The study was conducted in Denmark, Hungary, Norway,
 Poland, Sweden and The Netherlands.  A total of 627 patients, out of the 1,000
 planned, were already enrolled in the study.
     On January 16, 2003, following an interim safety analysis, the DSMB raised
 the issue of a potential excess risk of death in patients on active treatment.
 Before considering a new protocol, an in-depth analysis and a clear
 interpretation of the present data are necessary.
     Dronedarone is a compound which is currently assessed as a potential
 antiarrhythmic drug.  The Phase III clinical program comprises:
      - Two pivotal trials in the maintenance of sinus rhythm in patients with
        atrial fibrillation EURIDIS (in Europe) and ADONIS (in North America,
        South America, Australia and South Africa)
      - One morbidity-mortality study in high risk patients: ANDROMEDA
     Recruitment in these two pivotal trials, EURIDIS and ADONIS, is now
 completed.  These studies are currently ongoing and are closely supervised by
 their respective Steering Committees and Data Safety and Monitoring Boards.
     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 uncertainties that could cause
 actual results to differ materially from those described in the
 forward-looking statements:  the ability of Sanofi-Synthelabo to expand its
 presence profitability in the United States; the success of Sanofi-Synthelabo
 research and development programs; the ability of Sanofi-Synthelabo to protect
 its intellectual property rights; and the risks associated with reimbursement
 of healthcare 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.
      Media Contact:  Jean-Marc Podvin; Vice President, Media Relations:
                      0 11 33 1 53 77 42 23

SOURCE Sanofi-Synthelabo