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
IMPORTANT DISCLAIMER: The information herein is not intended to be an offer to buy or sell, or a solicitation of an offer to buy or sell, any securities and including any expression of
opinion, has been obtained from or is based upon sources believed to be reliable but is not guaranteed as to accuracy or completeness although Société Générale (“SG”) believe it to be
clear, fair and not misleading. SG, and their affiliated companies in the SG Group, may from time to time deal in, profit from the trading of, hold or act as market-makers or act as advisers,
brokers or bankers in relation to the securities, or derivatives thereof, of persons, firms or entities mentioned in this document or be represented on the board of such persons, firms or
entities. Employees of SG, and their affiliated companies in the SG Group, or individuals connected to then, other than the authors of this report, may from time to time have a position in or
be holding any of the investments or related investments mentioned in this document. Each author of this report is not permitted to trade in or hold any of the investments or related
investments which are the subject of this document. SG and their affiliated companies in the SG Group are under no obligation to disclose or take account of this document when advising or
dealing with or for their customers. The views of SG reflected in this document may change without notice. To the maximum extent possible at law, SG does not accept any liability
whatsoever arising from the use of the material or information contained herein. This research document is not intended for use by or targeted at private customers. Should a private
customer obtain a copy of this report they should not base their investment decisions solely on the basis of this document but must seek independent financial advice.
Important notice: The circumstances in which materials provided by SG Fixed & Forex Research, SG Commodity Research, SG Convertible Research, SG Technical Research and SG Equity
Derivatives Research have been produced are such (for example because of reporting or remuneration structures or the physical location of the author of the material) that it is not appropriate
to characterise it as independent investment research as referred to in European MIF directive and that it should be treated as a marketing material even if it contains a research
recommendation (« recommandation d’investissement à caractère promotionnel »). However, it must be made clear that all publications issued by SG will be clear, fair, and not misleading.
Analyst Certification: Each author of this research report hereby certifies that (i) the views expressed in the research report accurately reflect his or her personal views about any and all of
the subject securities or issuers and (ii) no part of his or her compensation was, is, or will be related, directly or indirectly, to the specific recommendations or views expressed in this report.
Notice to French Investors: This publication is issued in France by or through Société Générale ("SG") which is regulated by the AMF (Autorité des Marchés Financiers).
Notice to UK investors: This publication is issued in the United Kingdom by or through Société Générale ("SG") London Branch which is authorised and regulated by the Financial Services
Authority ("FSA") for the conduct of its UK business.
Notice To US Investors: This report is intended only for major US institutional investors pursuant to SEC Rule 15a-6. Any US person wishing to discuss this report or effect transactions in
any security discussed herein should do so with or through SG Americas Securities, LLC (“SGAS”) 1221 Avenue of the Americas, New York, NY 10020. (212)-278-6000. THIS RESEARCH
REPORT IS PRODUCED BY SOCIETE GENERALE AND NOT SGAS.
Notice to Japanese Investors: This report is distributed in Japan by Société Générale Securities (North Pacific) Ltd., Tokyo Branch, which is regulated by the Financial Services Agency of
Japan. The products mentioned in this report may not be eligible for sale in Japan and they may not be suitable for all types of investors.
Notice to Australian Investors: Société Générale Australia Branch (ABN 71 092 516 286) (SG) takes responsibility for publishing this document. SG holds an AFSL no. 236651 issued under
the Corporations Act 2001 (Cth) ("Act"). The information contained in this newsletter is only directed to recipients who are wholesale clients as defined under the Act.
US THIRD PARTY FOREIGN AFFILIATE RESEARCH DISCLOSURES:
The subject company of this research report currently is, or was during the 12-month period preceding the date of distribution of this report, a client of SG or its affiliates.
SG or its affiliates has received compensation for investment banking services from the subject company of this research report in the past 12 months.
SG or its affiliates expects to receive or intends to seek compensation for investment banking services from the subject company of this research report in the next 3 months.
SG or its affiliates acts as a market maker or liquidity provider in the equities securities that are subject of this research report.
IMPORTANT DISCLOSURES: Please refer to our website: http://www.sgresearch.socgen.com/compliance.rha
http://www.sgcib.com. Copyright: The Société Générale Group 2007. All rights reserved.

Source: https://www.premiumhebdo.com/assets/files/Note%20sanofi%20051107.pdf