IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
In 2007, ini tial re sults of tri als re lated to the AS PIRE HIGHER pro gram showed po ten tial ben e fits of
Tekturna/Rasilez in re duc ing a key biomarker of kid ney dis ease (AVOID) and in re duc ing the se ver ity of
heart failure (ALOFT).
In June 2008, data from the AVOID study were pub lished in the NEJM, dem on strat ing that aliskiren may
have po ten tial kid ney-pro tec tive ben e fits that are in de pend ent of its al ready proven abil ity to pro vide
pow er ful blood pres sure reductions.
Also, in June 2008, Novartis an nounced de tails of two long-term out come stud ies of aliskiren as part of its
AS PIRE HIGHER clin i cal trial pro gram. The two new stud ies will eval u ate the or gan pro tec tion po ten tial of
aliskiren for the treat ment of heart fail ure and pre ven tion of car dio vas cu lar dis ease in the el derly. As part
of the AS PIRE HIGHER clin i cal trial pro gram, aliskiren is be ing eval u ated in three ma jor out come stud ies.
The AL TI TUDE study, be ing con ducted in pa tients with type II di a be tes at high risk from car dio vas cu lar
and re nal events, will in ves ti gate whether aliskiren in com bi na tion with con ven tional ther apy de lays heart
and kid ney com pli ca tions. The AT MO SPHERE study aims to de ter mine the ef fects of aliskiren, in ad di tion
to stan dard ther apy, on mor bid ity and mor tal ity in acute and chronic con ges tive heart fail ure pa tients.
The APOLLO study will as sess aliskiren’s abil ity to pre vent car dio vas cu lar mor bid ity and mor tal ity in el -
derly pa tients with or with out hy per ten sion or other risk fac tors. Over all, the AS PIRE HIGHER clin i cal trial
pro gram com prises 14 tri als in volv ing more than 35 000 pa tients. Short-to-me dium term stud ies be ing
car ried out as part of the pro gram will eval u ate the or gan pro tec tion ben e fits of aliskiren in cardio-re nal
con di tions in clud ing heart fail ure, post-acute cor o nary syndromes, post-myocardial infarction, left
ventricular hypertrophy, coronary artery disease and diabetic nephropathy.
Lifecycle Man age ment: Novartis has de vel oped a fixed com bi na tion prod uct, Tekturna HCT com pris -
ing aliskiren and the di uretic, hy dro chlo ro thi a zide, for the treat ment of hy per ten sion. It was launched in
the USA in Feb ru ary 2008. It has been ap proved in Swit zer land and rec om mended for ap proval in Eu -
rope. In Eu rope, it will be known as Rasilez HCT.
Novartis is also de vel op ing a fixed dose com bi na tion of Diovan (valsartan) and aliskiren and this was
filed for ap proval in the USA in 2008 and Novartis an tic i pates an ap proval in 2009. Phase III tri als have
been con ducted in the USA, Can ada and Ger many for the treat ment of hypertension.
Com pe ti tion: Speedel’s (now Novartis) new renin in hib i tor, SPP 635, is in phase II tri als. Speedel is
also study ing other renin in hib i tors and has two in phase I tri als, SPP 1148 and SPP 676. Actelion (Swit -
zer land) is also study ing renin in hib i tors, and in 2003 formed an al li ance with Merck &Co to work on
these; their lead prod uct MK 8141 is in phase II tri als. GlaxoSmithKline has an al li ance with Vi tae
Pharmaceuticals to de velop renin in hib i tors. Many com pa nies have tried and failed to pro duce renin in hib -
i tors. It has been dif fi cult to find an ef fec tive mol e cule that can be given in once-daily tablets.
Sales/An a lyst Com ment: Tekturna sales in 2008 were $144 mil lion. Ac cord ing to Novartis, it has per -
formed well in a highly com pet i tive US mar ket place. Key driv ers have been broad clin i cal data dem on -
strat ing ef fi cacy in low er ing blood pres sure, its safety pro file and ris ing re im burse ment rates in US
for mu lary plans. Mor gan Stan ley an a lysts (Jan u ary 2009) fore cast sales of $291 mil lion in 2009 ($493
mil lion by 2012 and $532 mil lion by 2014, in clud ing com bi na tions, such as the fixed dose combination
with valsartan).
TEKTURNA HCT (aliskiren + hy dro chlo ro thi a zide), a fixed com bi na tion prod uct com pris ing the renin in -
hib i tor Tekturna (aliskiren) and the di uretic hy dro chlo ro thi a zide, for the treat ment of hy per ten sion, was
launched in the USA in Feb ru ary 2008. Ap proval was based on data from seven clin i cal tri als of aliskiren
alone and in com bi na tion with hy dro chlo ro thi a zide that in volved more than 6,200 pa tients. Sub mis sions
were made for four dif fer ent dos age com bi na tions of aliskiren and hy dro chlo ro thi a zide: 150/12.5mg tab -
lets, 150/25mg tab lets, 300/12.5mg tab lets and 300/25mg tab lets. This com bi na tion was ap proved in
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