IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Alimentary Tract and Metabolism Agents
MAb, IL-17A, Novartis AIN 457 A7E, D5B II
neurokinin 1 and 2 antagonist DNK 333 A3G II
AIN 457, a monoclonal an ti body against interleukin-17A, was in phase II tri als in 2008 for the treat ment
of pso ri a sis and Crohn’s dis ease. AIN 457 is also in phase I tri als in Eu rope for the treat ment of pso ri a sis.
De vel op ment for the in di ca tion of rheu ma toid ar thri tis have been terminated.
Clin i cal Data: In Jan u ary 2008, a ran dom ized, dou ble-blind, pla cebo-con trolled, par al lel-group,
proof-of-con cept, phase II study ini ti ated in the USA and Can ada as sess ing the ef fi cacy, safety and
tolerability of two sin gle in tra ve nous in fu sions of AIN 457 10 mg/kg in 72 pa tients with mod er ate to se -
vere ac tive Crohn’s dis ease. Pri mary out come mea sures will in clude mean Crohn’s dis ease ac tiv ity in dex
(CDAI) and sec ond ary out come mea sures will in clude per cent age of pa tients achiev ing re mis sion, main -
te nance of remission, safety and tolerability.
DNK 333 is a dual neurokinin 1 and 2 an tag o nist in phase II tri als with Novartis for the treat ment of ir ri ta -
ble bowel syn drome (IBS). It had been pre vi ously stud ied for the treat ment of rhi ni tis, asthma and pul -
mo nary ob struc tive dis ease, but de vel op ment in these in di ca tions have been discontinued.
In Jan u ary 2008, it was re ported that Novartis has com pleted a ran dom ized, dou ble-blind, pla cebo-con -
trolled, par al lel-group, multicenter, phase II study eval u at ing the ef fi cacy and safety of DNK 333 25 mg
bid given orally for four weeks in 180 fe male pa tients with di ar rhea-pre dom i nant ir ri ta ble bowel syn -
drome (IBS-D). Pri mary out come mea sures in cluded weekly re sponse to sat is fac tory re lief as sess ments,
IBS-re lated ab dom i nal pain/dis com fort and over all IBS-D symp toms. Sec ond ary out come mea sures in -
cluded oc cur rence and con trol of bowel ur gency, change in stool fre quency, se ver ity of ab dom i nal bloat -
ing and se ver ity of ab dom i nal pain/discomfort. The trial was completed in October 2007.
Antineoplastics/Immunomodulating Agents
filgrastim — L3A1 Approved
drug delivery system, poliglumex
paclitaxel CT 2103, PG-TXL, CHC 12103 L1C, V7A III
fingolimod FTY 720 L4A, N7X III
midostaurin PKC 412, CGP 41251 L1X9, S1X III
pasireotide SOM 230 L2A9 III
patupilone EPO 906 L1D III
vadimezan ASA 404, AS 1404 L1X9 III
cancer therapy AUY 922 L1X9 II
gimatecan ST 1481, CPT 184, LBQ 707 L1X9 II
lucatumumab HCD 122 L1X9 II
MAb, CSF1, Novartis MCS 110 L1X3 II
panobinostat LBH 589 L1X9 II
sotrastaurin AEB 071 L4A II
anticancer agent AEE 788 L1X4 I
cancer therapy RAF 265 L1X4 I
dovitinib TKI 258, CHIR 258 L1X4 I
MAb, cancer, MorphoSys/Novartis BHQ 880 L1X3 I
MAb, DR5, Novartis LBY 135 L1X3 I
PI3K NVP BEZ235, BEZ 235 L1X9 I
PI3K inhibitor BGT 226 L1X4 I
S1P receptor agonist KRP 203 L4A I
Bcr-Abl inhibitors, Lilly/Novartis — L1X4 Preclinical
cell cycle inhibitor AT 9311 L1X9 Preclinical
HSP 90 inhibitor HSP 990 L1X9 Preclinical
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