Sanofi publishes a positive study.
Posted on June 2, 2008
Sanofi-aventis publishes positive judged results of his study Athena on the Multaq, his treatment of the fibrillation little finger, a disturbance of the cardiac rhythm being able to provoke vascular cerebral accidents.
The study presented to the Corporation of American Cardiac Rythmologie was realized in blind double, on 4,628 recruited patients in 37 countries.
His vocation was to evaluate a treatment intend for the taken one in charge of the fibrillation little finger in complement of the conventional treatments while measuring the impact on the reduction of the hospitalizations cardiovasculaires or the mortality.
She revealed that the Multaq, the commercial name of the molecule DronГ©darone of Sanofi, diminished of 24% the risk of hospitalization of origin cardiovasculaire or of death in comparison with placebo.
The study also proved as the Multaq allowed a reduction of 30% of the risk of death cardiovasculaire in comparison with placebo (neuter substance).В In addition, the treatment drove to a decrease of 45% of the risk of death for causes cardiac arrhythmia.
The undesirable effects the most frequently retrieved in comparison with placebo are type liqueur (26% against 21%), skin (10% against 8%) as well as an elevation of the sanguine crГ©atine (4.7% against 1%), specified the nВ°4 world-wide one of the pharmacy.
TOWARDS A MARKETING BEGINNING 2009 TO THE WORE
“These results never were obtained for 20 years in this pathology”, underlined John Philippe Santoni, the director of the international development of sanofi-aventis at the time of a press conference.
“The study results are positive”, comments on for its part an analyst under cover with anonymity.
On the basis of these new data clinics, Sanofi foresees to submit of here the third quarter 2008 a request of authorization of placement on the market with the European Agency of the medicine as well as a probate request with sanitary American authorities.
John rock Lehner, director of the medical matters of sanofi-aventis, considered that Multaq could be marketed to the first quarter 2009 to the United States, for the file will be able to be examined in the six following months his deposit.
In Europe, it followed, the treatment could be on the market towards the end of next year.
Sanofi-aventis did not give indication on the potential sales of this medicine but underlined that the fibrillation little finger touches about 2.5 millions of persons to the United States and 4.5 million in the European Union.
John rock Lehner specified that the fibrillation little finger represented in terms of cares an annual cost of 3,000 Euros by patient.
In September 2006, sanofi-aventis had withdrawn his request of authorization of placement on the market in Europe of the Multaq, a week after wiping a file refusal from the
FDA.
The positive results of the study Athena could counterbalance the negative impression left by the launch project in Europe of a generic one of Plavix, the anticoagulant star of Sanofi, and by the invalidation to the United States of the patent of the ANTI-l’anti-thrombotique anti anti l’anti-thrombotique Lovenox.
They could allow the rebond of the title Sanofi that lost close to 23% since the year beginning.В Second French stock market capitalization there are again eighteen months, Sanofi is today in fifth position, behind Total, EDF, ArcelorMittal and BNP Paribas.
Thursday, the action closed on a gain of 0.10% to 48.50 Euros while the CAC 40 was stable and that the European sectoral index progressed of 1.18%.
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