IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
III tri als have been con ducted in the USA, Can ada and Eu rope for the treat ment of hy per ten sion. Novartis
re ported in Jan u ary 2009 that an NDA was filed in the USA in late 2008.
In April 2007, Novartis ini ti ated a ran dom ized, dou ble-blind, par al lel-group, pla cebo-con trolled, mul ti na -
tional phase III trial in the USA, Bel gium, Can ada, the Czech Re pub lic, Ger many, Hun gary, the Neth er -
lands, Po land, Rus sia, Spain and Swe den eval u at ing the ef fi cacy of aliskiren and valsartan ver sus pla cebo
in low er ing lev els on NT-proBNP in 1100 sta bi lized pa tients with post-acute cor o nary syn dromes. Pri mary
out come mea sures will de ter mine if aliskiren or valsartan alone and as a com bi na tion re duce the lev els of
NT-proBNP com pared with pla cebo. Sec ond ary out come mea sures will in ves ti gate if aliskiren or valsartan
alone and as a combination reduce the rate of adverse cardiac events.
VALSARTAN + AMLODIPINE + HY DRO CHLO RO THI A ZIDE: In Jan u ary 2009, Novartis re ported
that it was de vel op ing new car dio vas cu lar tri ple ther apy, a sin gle pill com bi na tion of its mar keted prod uct
valsartan plus amlodipine (Exforge), and the di uretic, HCTZ. It has been filed for ap proval in the USA.
Novartis noted that it ex pects an approval in 2009.
ALISKIREN + AMLODIPINE: In No vem ber 2008, Novartis re ported that it was de vel op ing a sin gle pill
com bi na tion of its mar keted prod uct aliskiren (Tekturna/Rasilez) and the cal cium an tag o nist
amlodipine. Novartis states that it ex pects this ther apy to be ap proved be fore the loss of mar ket ex clu siv -
ity for its flag ship car dio vas cu lar prod uct Diovan (valsartan) in the USA in Sep tem ber 2012. It was in
phase III trials in February 2009.
ALISKIREN + AMLODIPINE + HY DRO CHLO RO THI A ZIDE: In No vem ber 2008, Novartis re ported
that it was de vel op ing new car dio vas cu lar tri ple ther apy, a sin gle pill com bi na tion of its mar keted prod uct
aliskiren (Tekturna/Rasilez), the cal cium an tag o nist amlodipine, and the di uretic, HCTZ. Novartis
states that it ex pects this ther apy to be ap proved be fore the loss of mar ket ex clu siv ity for its flag ship car -
dio vas cu lar prod uct Diovan (valsartan) in the USA in Sep tem ber 2012. In its 2008 an nual re port,
Novartis noted that it expects a filing in 2010.
LCZ 696, an oral an gio ten sin II re cep tor blocker (ARB) and neu tral endopeptidase (NEP) in hib i tor, is in
phase II tri als with Novartis. In No vem ber 2008, Novartis stated, “LCZ 696 is set to en ter phase III tri als
in 2009 as a po ten tial op tion to re place ACE in hib i tors as the stan dard of care for heart fail ure. Phase II
stud ies in volv ing 1,300 pa tients showed LCZ 696 pro vided su pe rior blood pres sure re duc tions com pared
with valsartan alone, and was well-tol er ated with no reported cases of angioedema.”
Clin i cal Data: In Oc to ber 2007, Novartis ini ti ated a multicenter, ran dom ized, dou ble-blind, pla -
cebo-con trolled, dose-rang ing phase II trial in the USA and Ger many eval u at ing the ef fi cacy and safety of
LCZ 696 com par a tively with valsartan af ter an 8-week treat ment in 1,320 pa tients with es sen tial hy per -
ten sion. Pri mary out come mea sures will in clude mean sit ting di a stolic blood pres sure (MSDBP) low er ing
from base line to week eight com pared with valsartan and sec ond ary out come mea sures will in clude
mean sit ting sys tolic blood pres sure (MSSBP)/MSDBP low er ing from base line to week eight com pared
with pla cebo. Re sults were re ported in De cem ber 2008. The study achieved its pri mary ob jec tive: LCZ
696 re duced blood pres sure to a greater ex tent than valsartan alone. LCZ 696 was well tolerated and no
cases of angioedema were observed.
Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) fore cast ini tial sales of $25 mil lion in
2011 ($75 mil lion by 2013).
PEGMUSIRUDIN (SPP 200) is a long-act ing di rect thrombin in hib i tor, in phase II tri als with Speedel
(Swit zer land), which was ma jor ity ac quired by Novartis in July 2008.
Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) fore cast sales of $50 mil lion in 2012
and $100 mil lion in 2013.
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