Taux NS (ensembledumarchtl) = Taux

Taux NS (ensembledumarchtl) = Taux deNS (bithtlrapie) X Part bilherapie + Taux deNS (monothtlrapie) X Part monothtlrapie
Taux deNS (monothtlrapie) = Taux NS (ensemble du marchll) - Taux de NS (bithtlrapie)
Taux de NS (monothtlrapie) = 12,6% - 20% X 25% Taux deNS (monotherapie) = 7,6 %

364. Ainsi, sur cette base :

le taux de « NS » pour la molecule de clopidogrel serait de 12,6% (estimation de la
CNAMTS);

le taux de « NS » pour le clopidogrel dans les cas de l'indication SCA, qui est protegee par un brevet, ne figure pas dans les AMM des generiques et correspond a 25 % des patients, serait de 27,6% ;

le taux de « NS » pour le clopidogrel dans les autres indications hors SCA, qui ne sont pas protegees, figurent dans les AMM des generiques et correspondent a 75 % des
patients, serait de 7,6 %.

365. Par consequent, si on se base sur les chiffres de la CNAMTS precites, le fait d'exclure les ordonnances correspondant au SCA conduit a faire baisser de 5 % le taux de mentions « NS » pour le clopidogrel, qui passe de 12,6% a 7,6 %.

366. L'ecart entre le taux de« NS »pour Plavix hors SCA (7,6 %) et celui toutes molecules confondues
(5 %), devient alors extremement reduit.

367. Et comme il a ete indique ci-dessus (voir pts. 20 et 350), cet ecart peut tout a fait s'expliquer par les caracteristiques propres a Plavix, en particulier le fait qu'il traite une pathologie cardiovasculaire grave et systematiquement chronique, dont les patients sont souvent ages,
fragiles et polymediques, en particulier ceux souffrant de SCA, pour lesquels la frequence de survenue des complications, des recidives et de la mortalite, ne sont pas negligeables.
368. Par consequent, l'existence d'une indication encore protegee, qui ne figure pas dans I'AMM des generiques de clopidogrel et qui correspond a environ 25 % des patients, explique un taux
eventuellement plus eleve d'ordonnances « NS ».

369. 11 resulte de ce qui precede que la Decision retient a charge contre Sanofi-Aventis France la proportion d'ordonnances « NS » pour le clopidogrel , qui serait superieure a la moyenne des
autres molecules, sans jamais prouver en quoi cette proportion pretendument superieure serait le resultat de l'information objective communiquee par Sanofi-Aventis France.
370. Des lors qu'il existe des raisons specifiques, exterieures a Sanofi-Aventis France, de nature a expliquer la proportion d'ordonnances « NS » pour le clopidogrel, notamment le fait que les ordonnances « NS » existent pour toutes les molecules generiquees, que le clopidogrel traite une
pathologie cardiovasculaire chronique et lourde, dont les patients sont souvent ages et fragiles, en particulier ceux souffrant de SCA, et que les generiques de clopidogrel ne disposaient pas de
l'indication SCA, la Decision ne pouvait pas attribuer ces ordonnances « NS » a l'information
objective communiquee par Sanofi-Aventis France.

Résultats (Anglais) 1:

rate ns (ensembledumarchtl) = dens rate (bithtlrapie) x share bilherapie rate dens (monothtlrapie) x
dens share monothtlrapie rate (monothtlrapie) rate = ns (all marchll) - rate ns (bithtlrapie)
ns rate (monothtlrapie) = 12.6% - 20% x 25% rate dens (monotherapy) = 7.6%
364. and, on this basis:

rate "ns" to the molecule of clopidogrel would be 12,6% (estimated CNAMTS
)

rate "ns" for clopidogrel in case of indication sca, which is protected by a patent, does not appear in the amm of generic and corresponds to 25% patients would be 27.6%, the rate of

"ns" for clopidogrel in other indications outside sca, which are not protected, included in the amm of generic and correspond to 75%
patients would be 7.6%.
365. therefore, if based on figures ABOVE CNAMTS, the exclusion orders corresponding to sca leads to lower 5% rate mentions "ns" for clopidogrel, which rose from 12.6% was 7.6%.
366. the gap between the rate of "ns" for plavix off sca (7.6%) and all molecules combined
(5%)becomes extremely reduced.
367. and as was pointed out above (see pt. 20 and 350), this difference can be explained entirely by a plavix own characteristics, in particular the fact that systematically addresses a serious and chronic cardiovascular disease, patients whose ages are often fragile and polymedicated
, especially those with sca,for which the frequency of occurrence of complications, recurrences and mortality are not negligible 368.
. therefore, the existence of a protected indication yet that does not appear in i'amm of generic clopidogrel, which corresponds to approximately 25% of patients, says a rate
possibly more pupil orders "ns".

369.11 results from the above that the decision holds a charge against sanofi-aventis France the proportion of prescriptions "ns" for clopidogrel, which is superior to the average of
other molecules, without demonstrating how this proportion is allegedly superior the result of objective information communicated by sanofi-aventis France.
370.of when there are specific reasons to External sanofi-aventis France, likely to explain the proportion of prescriptions "ns" to clopidogrel, including the fact that "ns" exist for all generiquees molecules that orders clopidogrel treat a chronic and heavy
cardiovascular disease, including patients are often fragile and ages,especially those with sca, and that generic clopidogrel lacked
indication sca, the decision could not assign these orders "ns" has objective information
communicated by sanofi-aventis France.

Résultats (Anglais) 2:

Rate NS (ensembledumarchtl) = rate deNS (bithtlrapie) X Part bilherapie rate deNS (monothtlrapie) X Part monothtlrapie
deNS (monothtlrapie) rate = rate NS (main) - rate of NS (bithtlrapie)
rate of NS (monothtlrapie) = 12.6%-20%-25% rate deNS (monotherapy) X = 7.6%

364. Thus, on this basis:

'NS' rate for the molecule of clopidogrel would be 12.6% (estimate of the
CNAMTS);

'NS' rate for clopidogrel in the case of indication SCA, which is protected by a patent, is not included in the marketing authorisation of the generic, and is 25% of patients, 27.6%;

'NS' rate for clopidogrel in other indications out of SCA, which are not protected, are included in the marketing authorisation of generics and correspond to 75% with
.patients, would be 7.6%.

365. Therefore, based on the figures of the CNAMTS referred to above, the fact to exclude orders corresponding led ACS to do lower 5% mentions 'NS' for clopidogrel, which has grown from 12.6% 7.6%.

366. The gap between the rate of 'NS' for Plavix outside the SCA (7.6%) and that all molecules combined
(5 %),. becomes extremely reduced.

367. And as it has been says above (see points 20 and 350), this gap can quite explain by the specific characteristics of Plavix, in particular the fact that it deals with a severe cardiovascular pathology and chronic systematically, which patients often are ages,
fragile and polymedicalised, especially those suffering from SCA, for which the frequency of occurrence of complications, recurrences and mortality, are not inconsiderable.
368. Consequently, the existence of an indication yet protected, which is not in I'AMM of generic clopidogrel and corresponding has about 25% of patients, says a rate
possibly higher orders 'NS'.

369. 11 follows what preceded that Decision holds a charge against Sanofi-Aventis France the proportion of 'NS' prescriptions for clopidogrel, which would be higher was the average of
other molecules, without ever prove what this allegedly higher proportion would be the result of the objective information provided by Sanofi-Aventis France.
370. Therefore there are specific, external reasons a Sanofi-Aventis France, explaining the proportion of orders 'NS' for clopidogrel, including the fact that 'NS' orders exist for all molecules generiquees, clopidogrel deals a
cardiovascular pathology chronic and heavy, whose patients are often ages and fragile, in particular those suffering from SCA, and that generic clopidogrel lacked of
the SCA Decision indication could not assign these orders 'NS' has information
objective communicated by Sanofi-Aventis France.

Résultats (Anglais) 3:

Rate NS (ensembledumarchtl) = Rate dens (bithtlrapie) X Part Rate bilherapie dens (monothtlrapie) X Part monothtlrapie
Rate dens (monothtlrapie) = Rate NS (whole marchll) - Rate of NS (bithtlrapie)
Rate of NS (monothtlrapie) = 12.6 % - 20% X 25% rate dens (monotherapy) = 7.6 %

364. Thus, on this basis:

the rate of "NS" for the molecule of clopidogrel would be 12,6% (estimation of the
CNAMTS) ;

the rate of "NS" for the clopidogrel in the case of the indication SCA, which is protected by a patent, does not figure in the AMM of generics and corresponds to 25 % of patients, would be 27.6 per cent ;

the rate of "NS" for the clopidogrel in other indications outside SCA, which are not protected, are contained in the AMM of generics and correspond to 75 % of
Patients, would be 7.6 % .

365. Therefore, if it is based on the figures of the CNAMTS mentioned above, the fact to exclude orders corresponding to the SCA led to lower rate by 5 per cent of particulars "NS" for the clopidogrel, which increased from 12.6 per cent was 7.6 % .

366. The gap between the rate of" NS "for Plavix outside SCA 7,6 %) and that all molecules confused
(5 % ),Then becomes extremely reduced.

367. And as it has been shown above (see pts. 20 And 350), this difference may everything has done is explained by the characteristics has Plavix, in particular the fact that it deals a pathology serious cardiovascular and chronic systematically, whose patients are often ages,
fragile and polymediques, in particular those suffering from SCA,For which the frequency of occurrence of complications, on recidivism and mortality, are not negligible.
368. Therefore, the existence of an indication yet protected, which does not appear in I'AMM of generic clopidogrel and which corresponds to approximately 25 % of patients, explains a rate
possibly higher orders" NS " .

369.11 Follows from the foregoing that the Decision retains a charge against Sanofi-Aventis France the proportion of prescriptions "NS" for the clopidogrel , which would be greater than the average of the
other molecules, without ever proving how this proportion allegedly superior would be the result of the objective information communicated by Sanofi-Aventis France.
370.When there are specific reasons, has external Sanofi-Aventis France, nature has explain the proportion of prescriptions "NS" for the clopidogrel, including the fact that the orders "NS" exist for all the molecules generiquees, as clopidogrel treaty a
pathology chronic cardiovascular and heavy, whose patients are often older and fragile,In particular those suffering from SCA, and that the generic clopidogrel did not have
the indication SCA, the Decision could not assign these orders "NS" has the information
objective communicated by Sanofi-Aventis France.