IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
In July 2008, Novartis re ported that a phase III trial in in fants and chil dren is un der way. The first reg u la -
tory sub mis sions, for use in in fants and chil dren, ac cord ing to Novartis, are planned for 2010.
AFLUNOV (vac cine, pre-pan demic in flu enza, Novartis) is a pre-pan demic vac cine which con tains the
MF59 adjuvant, against H5N1 in flu enza. The vac cine was filed for ap proval in the EU in 2006 and is in
phase II tri als in the USA. How ever, in June 2008 Novartis no ti fied the EMEA of its de ci sion to with draw its
MAA (sub mit ted in No vem ber 2006), seek ing ap proval of Aflunov for ac tive pre-pan demic im mu ni za tion
against H5N1 sub type of the in flu enza A vi rus. The de ci sion was based on a re quest by the CHMP for ad di -
tional clin i cal data be cause the main study had not been con ducted in com pli ance with Good Clin i cal Prac -
tice (GCP); the re quest could not be met within the timeframe allowed by the centralized procedure.
Aflunov was the first such vac cine sub mit ted to EU reg u la tory au thor i ties. Aflunov is based on the cur -
rently cir cu lat ing H5N1 in flu enza strain, and clin i cal data have dem on strated that it is pro tec tive for this
strain as well as of fer ing a de gree of pro tec tion from other re lated strains. Aflunov also con tains the MF59
adjuvant, strength en ing the im mune re sponse to the vac cine, and help ing to pro vide a de gree of
cross-strain pro tec tion. Clin i cal stud ies in more than 4,000 peo ple have dem on strated that Aflunov is as
safe as Fluad, the adjuvanted seasonal-flu vaccine from Novartis.
PTZ 601, a carbapenem an ti bi otic, en tered phase II tri als in the USA in 2008 with Protez (USA), which
was ac quired by Novartis in June 2008, in the treat ment of pa tients with com pli cated skin and skin struc -
ture in fec tions. PZ 601 is a 1-beta-methylcarbapenem with an ex tended spec trum of ac tiv ity against
multidrug-re sis tant Gram pos i tive patho gens, in clud ing methicillin-re sis tant Staph y lo coc cus aureus, and
Gram neg a tive bac te ria. Protez was ac quired by Novartis in June 2008. In June 2008, Novartis stated that
it plans to start ad di tional clin i cal tri als for PZ 601, with the aim of first regulatory submission in 2012.
Li cens ing: Protez li censed-in rights to PZ 601 in Eu rope and North Amer ica from orig i na tor Sumitomo
Pharma (now Dainippon Sumitomo, Ja pan) in 2005.
IDX 184, an oral, liver-tar geted nu cle o tide prodrug, be gan phase I/II tri als in Jan u ary 2009 in treat -
ment-na ive pa tients with chronic hep a ti tis C vi rus (HCV) ge no type 1 in fec tion. The dou ble-blind, pla -
cebo-con trolled, dose-es ca la tion, proof-of-con cept study will eval u ate the safety and an ti vi ral ac tiv ity of
four oral doses of the agent (25 to 100 mg), given once daily for three days. Each co hort will eval u ate ten
pa tients, eight re ceiv ing IDX 184 and two re ceiv ing pla cebo. A phase I trial begun in July 2008 has been
completed.
In April 2008, Idenix re ported re sults of pre clin i cal stud ies of IDX 184, a nucleoside RNA poly mer ase in -
hib i tor be ing de vel oped for the oral treat ment of hep a ti tis C vi rus (HCV) in fec tion. IDX 184 was de rived
from Idenix’s pro pri etary liver-tar get ing tech nol ogy. In chim pan zees with HCV ge no type 1 in fec tion, oral
ad min is tra tion of 10 mg IDX 184 once-daily for four days re sulted in a mean vi ral load re duc tion of 2.3
log10. In a seven-day tox i col ogy study in Cynomolgus mon keys, oral doses of 600 mg/kg per day re -
sulted in no ob served tox ic i ties, in clud ing gas tro in tes ti nal or he ma to log i cal, or ab nor mal blood chem is try.
In an HCV replicon model IDX 184 showed ad di tive an ti vi ral ac tiv ity in com bi na tion with HCV pro te ase in -
hib i tors and in ter feron, and syn er gis tic ac tiv ity in com bi na tion with ribavirin. IDX 184 was ac tive against
HCV with pro te ase and non-nucleoside in hib i tor drug resistance mutations. Idenix is planning to file an
IND for IDX 184 during 2008.
Li cens ing: In 2003, Novartis paid $255 mil lion for ap prox i mately 54% of pri vately-owned Idenix’s out -
stand ing cap i tal stock, gain ing rights to de velop and com mer cial ize Tyzeka (telbivudine) and other drug
can di dates dis cov ered by Idenix. Novartis was re ported to hold a 56% stake in Idenix in 2008.
IDX 899: IDX 899 is a non-nucleoside re verse tran scrip tase in hib i tor (NNRTI), in phase II tri als with
Idenix, which is ma jor ity-owned by Novartis.
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