IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
SPP 635 is a renin 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. Speedel is de vel op ing SPP 635 for the po ten tial treat ment of hy per ten sion. SPP 635
was gen er ated from the com pany’s SPP 600 pro gram to de velop a se ries of renin in hib i tors. Speedel has
car ried out a Eu ro pean phase IIa trial of SPP 635 in the treat ment of hy per ten sion. Re sults have been re -
ported for this trial. In 2007, Speedel was re ported to be plan ning a fur ther phase II trial in a spe cial pop u -
la tion of di a betic pa tients with mild-to-moderate hypertension.
Clin i cal Data: Re sults have been re ported for a dou ble-blind, pla cebo-con trolled, ran dom ized, phase IIa
trial to eval u ate the safety and ef fi cacy of SPP 635. Thirty five male and fe male pa tients with
mild-to-mod er ate hy per ten sion re ceived ei ther a sin gle dos age level of SPP 635 once-daily, or pla cebo,
for four weeks. At the end of the treat ment pe riod, it was found that sit ting sys tolic blood pres sure was
sig nif i cantly re duced in the SPP 635 treat ment group by 17.9 mmHg, from a mean of 156.6 mmHg at
base line to 138.7 mmHg (p less than 0.001). The pla cebo group re mained un changed (mean of 156.1
mmHg at base line to 153.3 mmHg af ter four weeks). Di a stolic blood pres sure was also sig nif i cantly re -
duced by 9.8 mmHg in the SPP 635 treat ment group, from a mean of 91.3 mmHg to 81.5 mmHg (p less
than 0.001) com pared with pla cebo (95.3 to 93.3 mmHg). These mea sure ments were taken at trough,
24 h af ter the pre vi ous med i ca tion. Sim i lar re sults were ob served for am bu la tory blood pres sures which
were re duced both dur ing the day as well as in the night and these data con firmed the use of SPP 635 as a
once-a-day drug. SPP 635 was found to be safe and well-tol er ated over the four week treat ment pe riod.
No se ri ous ad verse events were re ported, nor were there any clinically significant changes in laboratory
safety parameters.
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.
APP 018/APL 180 was in phase I tri als in the USA in 2008 for the treat ment of ath ero scle ro sis. In an
apoE null mouse plasma model APP 018 re mod eled HDL into pre-beta HDL. The pre-beta HDL
peroxidized lipids from LDL and in ac ti vated them. This re duced per ox ides, in flam ma tory cell ac ti va tion
and led to less cho les terol ac cu mu la tion in ves sel walls. This al lowed ves sel wall le sions to re gress.
Novartis is also con duct ing ad di tional pre clin i cal studies with the L-enantiomer only.
LCI 699, an aldosterone synthase in hib i tor, was in phase I tri als in 2008 as a po ten tial treat ment for hy -
per ten sion.
VNP 489 is an in hib i tor of an gio ten sin II re cep tor blocker (ARB) and neu tral endopeptidase (NEP), in de -
vel op ment as a po ten tial ther apy for the treat ment of hy per ten sion. It was in phase I tri als in 2008. A reg -
u la tory fil ing is an tic i pated after 2010.
Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) fore cast ini tial sales of $50 mil lion in
2012 and $100 mil lion in 2013.
SPP 1148: Speedel is de vel op ing SPP 1148, a renin in hib i tor from its SPP 1100 se ries, for the treat ment
of hy per ten sion and re lated end-or gan dis ease. A phase I trial to study the safety and tolerability of sin gle
and mul ti ple oral doses of SPP 1148 in healthy vol un teers has been ini ti ated. This ran dom ized, pla -
cebo-con trolled trial will as sess the pharmacokinetics of SPP 1148 and its ca pac ity to in hibit the
renin-angiotensin system.
SPP 676: Speedel is de vel op ing SPP 676, a renin in hib i tor, for the treat ment of hy per ten sion and re lated
dis eases. It orig i nated from Speedel’s SPP 600 se ries of renin in hib i tors. A phase I trial of SPP 676 ini ti -
ated in October 2007.
SPP 800: In 2006, Speedel was re ported to be de vel op ing a se ries of small mol e cule renin in hib i tors,
des ig nated SPP 800, as po ten tial ther a peu tics in car dio vas cu lar and met a bolic dis eases.
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