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Microsoft word - desknote_cie_-_sanofi-aventis_-_419242_fr_l.doc

Reco. confirmée Mortalité globalement similaire entre prasugrel et Plavix, en raison de saignements fatals Q Actualité Les résultats de l’essai clinique de grande envergure de phase 3 (TRITON-TIMI 38) sur prasugrel, concurrent du Plavix développé par Eli Lilly/Sankyo, ont été présentés hier à l’occasion du congrès de l’American Heart Association. Lilly a par ailleurs organisé le 4/11 une conférence téléphonique. Nous anticipions une efficacité supérieure avec toutefois des saignements similaires, la véritable problématique reposant toutefois sur la pertinence clinique de ces résultats dans la mesure où la charge de Plavix utilisée était de moitié inférieure à celle utilisée maintenant couramment. Le profil d’effets secondaires du prasugrel apparaît moins bon que prévu, limitant la menace à court terme qu’il pourrait représenter s’il devait obtenir son autorisation de mise sur le marché (ce qui reste à voir). Dans cet essai de grande échelle mené sur 13 608 patients, l’efficacité du prasugrel administré en plus d’une faible dose d’aspirine s’est révélée supérieure à celle du clopidogrel (Plavix), administré également en plus d’une faible dose d’aspirine, pour réduire les risques d’accidents cardio-vasculaires graves chez les patients souffrant d’une insuffisance coronarienne aiguë et subissant une intervention coronarienne percutanée. Notons toutefois que les saignements fatals provoqués par le traitement étaient 4 fois supérieurs avec prasugrel (comparé au Plavix). Globalement, le taux de mortalité n’a pas varié entre les deux groupes. Selon nous, Lilly/Sankyo devra sensiblement augmenter le nombre d’essais cliniques à grande échelle s’il souhaite que prasugrel devienne Q Impact Les résultats concernant Prasugrel démontrent la difficulté de trouver un produit plus efficace que Plavix mais ne présentant pas d’effets secondaires (saignements) plus néfastes. Lilly/Sankyo devrait déposer sa demande d’enregistrement auprès de la FDA avant fin 2007. Reste à savoir si la FDA approuvera prasugrel sur la base de ces données avant fin 2009. Q Objectif de cours & recommandation Recommandation Achat maintenue avec un objectif de cours de 77 €. Le cours du titre Sanofi-Aventis n’a pas réagi après l’issue positive concernant le brevet de Plavix aux Etats-Unis alors que les investisseurs étaient encore sous le choc de la récente décision négative du Comité consultatif de la FDA sur Acomplia et anticipaient l’avènement inéluctable de la concurrence avec prasugrel. La voie est Q Prochains évènements & catalyseurs 10 décembre : présentation des résultats l’étude de phase IIb TREK avec AVE5026, un anti-coagulant qui pourrait potentiellement remplacer Lovenox. Les données partielles communiquées lors de la journée R&D du 17/09 ont montré une efficacité supérieure par rapport au Lovenox ainsi qu’un meilleur profil d’effets secondaires SG a été seul teneur de livre associé de l'émission de titres obligataires senior (FRN 01/12/2008 EUR) par Sanofi-Aventis La Société Générale et ses filiales détiennent une participation de 1% ou plus dans Sanofi-Aventis. PLEASE SEE IMPORTANT DISCLAIMER AND DISCLOSURES ON LAST PAGE Sanofi-Aventis
Additional information (SANOFI-AVENTIS) The major results are summarised in the two tables below, the first one on efficacy end-points, the second one on the bleeding end-points, as published in the New England Journal of Source: Wiviott SD, Braunwald E, McCabe CH, et al. N Eng J Med 2007; 357:2001-2015 Source: Wiviott SD, Braunwald E, McCabe CH, et al. N Eng J Med 2007; 357:2001-2015; (a) key safety end-point; (b) Relates to the number of patients who underwent CABG (179 in the prasugrel group and 189 in the clopidogrel group) Données normalisées Marge d'EBITDA (%) Overall, no difference in mortality when all events are considered Overall, for every 1000 patients treated with prasugrel as compared with clopidogrel, 23 Myocardal Infarcts (MI) were prevented, with an excess of six non-CABG-related TIMI major Recherche crédit* STABLE. Actuellement, le principal moteur hemorrhages. The investigators of TRITON-TIMI 38 themselves conclude in their article de crédit de Sanofi est l'OPA potentielle sur Bristol-Myers Squibb, et la façon dont elle published today in the NEJM that “when considering the choice of antiplatelet regimens for différentes combinaisons de financement the treatment of patients with ACS who are undergoing PCI, clinicians need to weigh the dette/actions, à 75%, 50% et 25%, le levier financier de l'entité combinée pourrait se benefits and risks of intensive inhibition of platelet aggregation.” dégrader jusqu'au niveau de notation midà low single-A ou rester en ligne avec les The TRITON–TIMI 38 study validates the hypothesis that greater degrees of adenosine diphosphate–mediated platelet inhibition (the mechanism of action by which ticlopidine, Plavix’ ancestor, a Sanofi product and Plavix are working) are indeed associated with a greater suppression of clinical ischemic events, but as noted in the Editorial of today’s NEJM: “Thus, there is a price to pay for greater platelet inhibition and the accompanying reduction in ischemic events: higher rates of serious bleeding. (…) In TRITON–TIMI 38, for each death from cardiovascular causes prevented by the use of prasugrel as compared with clopidogrel, approximately one additional episode of fatal bleeding was caused by prasugrel. (…)TRITON– TIMI 38 was a clinical trial, and as in all trials of antithrombotic therapy, patients perceived to be at high risk for bleeding were excluded. Thus, in a “real-world” setting, such as in an
elderly patient with multiple coexisting conditions, the risk of major bleeding and even
fatal bleeding may be increased to an even greater degree than was seen in TRITON–
TIMI 38.”
Sanofi-Aventis
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