IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
ta tive ap proval by the FDA for ge neric valsartan tab lets. Teva re ceived ten ta tive ap proval for generic
Diovan in June 2008.
Clin i cal Data: Diovan acts di rectly on the vas cu lar tis sue, block ing the car dio vas cu lar ef fects of an gio -
ten sin II, which in clude vasoconstriction and the re lease of aldosterone (a hor mone which pro motes the
re ten tion of wa ter and so dium in the body) from the adrenal gland.
Novartis be lieves Diovan may play a role in man ag ing other con di tions be sides hy per ten sion, in clud ing
con ges tive heart fail ure (CHF), myo car dial in farc tion and di a be tes, where it has been shown to re duce
microalbuminuria more than ACE in hib i tors. Over 35,000 pa tients have been or are cur rently in volved in
a va ri ety of tri als. Novartis has com pleted sev eral ma jor tri als as fol lows: Valsartan Heart Fail ure Trial
(Val-HeFT), which com pared valsartan to pla cebo in 5,010 heart fail ure pa tients re ceiv ing stan dard treat -
ment and was used to gain the heart fail ure in di ca tion, with sev eral sets of data were re ported from 2000
to 2003; VAL IANT (Valsartan in Acute Myo car dial In farc tion) trial, which com pared Diovan with the ACE
in hib i tor captopril in terms of health and sur vival in post-MI pa tients, and in di cated that Diovan is as ef -
fec tive as captopril in re duc ing mor tal ity in pa tients at high risk of car dio vas cu lar events af ter myo car dial
in farc tion; MARVAL (Microalbuminuria Re duc tion with Valsartan) trial, a trial of 332 Type 2 di a betic pa -
tients with microalbuminuria and ei ther nor mal or high blood pres sure who re ceived valsartan or
amlodipine on top of other antihypertensive ther apy (bendrofluazide and doxazosin), which in di -
cated that Diovan was a more ef fec tive treat ment than amlodipine for slow ing the pro gres sion of
microalbuminuria; QoLITY, which found that hy per ten sive pa tients who switched to Diovan or Diovan
HCT af ter be com ing in tol er ant to com monly pre scribed antihypertensive drugs, ex pe ri enced sig nif i cantly
im proved qual ity of life while their sys tolic and di a stolic blood pres sure con trol was ad e quately main -
tained; AADVANCE study, which in di cated that Diovan low ered blood pres sure to ag gres sive rec om -
mended tar get blood pres sure goals as ef fec tively as amlodipine; and VALUE (Valsartan Antihypertensive
Long-term Use Eval u a tion), a trial de signed to com pare the long-term ben e fits of Diovan with those of
Pfizer’s (USA) cal cium an tag o nist Norvasc (amlodipine), in pa tients with es sen tial hy per ten sion with a
high risk for car dio vas cu lar events which while con firm ing the long-term cardioprotective pro file of
Diovan, found there was no statistically significant difference between Diovan and Norvasc in reducing
cardiac mortality and morbidity (the primary endpoint of the trial).
The NAV I GA TOR (Nateglinide And Valsartan in Im paired Glu cose Tol er ance Out comes Re search) trial, is
on go ing. This is a mul ti na tional study that will in volve about 7,500 in di vid ual in over 30 coun tries to in -
ves ti gate whether the oral antidiabetic agent Starlix (nateglinide) or Diovan can pre vent di a be tes and/or
car dio vas cu lar events in in di vid u als with im paired glu cose tol er ance that are at high risk for
cardiovascular events.
Lifecycle Man age ment: In 2007, Novartis launched a fixed-dose com bi na tion of Diovan with
amlodipine as Exforge. This marked the first com bi na tion of a cal cium chan nel blocker with an ARB, of -
fer ing a once-daily treat ment with a dual mech a nism of ac tion that com bines the ben e fits of both drugs in
one pill. Novartis filed a com bi na tion of valsartan and aliskiren for ap proval in the USA in late 2008. Ap -
proval is expected in 2009.
Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Diovan was the
num ber one prod uct in the AIIA class (C9C), with a 26.3% mar ket share and 12% fixed rate dol lar
growth. Num ber two was Merck & Co’s Cozaar (losartan), with a 16.3% mar ket share, but sales down
5% in fixed rate dol lar terms. Num ber three was Takeda’s Blopress (candesartan cilexetil) with an
11.4% mar ket share and 6% dol lar growth. Num ber four was Boehringer Ingelheim’s Micardis
(telmisartan), with an 8.9% mar ket share and 16% fixed rate dollar growth.
Sales/An a lyst Com ment: In 2008, Diovan’s net sales reached $5.7 bil lion (com bined with sales of
Co-Diovan), up 10% in lo cal cur rency terms and it was Novartis’ num ber one prod uct. Ac cord ing to
Novartis. sales grew steadily in all key mar kets world wide, with ar eas out side the USA ac count ing for
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