IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
In 2002, it was also ap proved in the USA and Eu rope for the treat ment of unresectable and/or ma lig nant
gas tro in tes ti nal stromal tu mors (GIST). It was ap proved for this in Ja pan in 2003. A warn ing of po ten tial
risk of gas tro in tes ti nal per fo ra tion when used in this in di ca tion was added in mid-2004. In 2002, it was
ap proved in Eu rope and the USA for use in as a first-line treat ment in early stage CML, and, on the ba sis of
the IRIS study data, some ex perts al ready con sider Glivec to be the stan dard of care for early CML. Can -
ada ap proved its use in newly di ag nosed CML in 2003. The FDA ex tended its in di ca tion to cover pe di at ric
use in Phil a del phia-pos i tive chronic myeloid leu ke mia in 2003, and also ap proved its use in pe di at ric CML.
In 2006, Novartis re ceived ap proval for Glivec in the US and Eu rope in four rare can cers:
dermatofibrosarcoma protuberans, cer tain forms of myeloproliferative dis or ders (MPD),
hypereosinophilic syn drome and sys temic mastocystosis, but in Oc to ber 2006 Novartis with drew its fil ing
in Eu rope for the treat ment of sys temic mastocytosis. The EMEA ad vi sory com mit tee had stated that it
did not have enough data to make a judgment on the benefit-risk balance of Glivec for this indication.
Glivec has three modes of ac tion: in CML it in hib its the bcr-abl ty ro sine kinase; in GIST it tar gets the Kit
pro tein pro duced by the c-kit gene; and in cer tain solid tu mors, Glivec acts on the platelet-de rived growth
fac tor (PDGF) re cep tor to pro duce ar rest of the cell cycle.
In 2005, a study pre sented at the ASCO meet ing showed that pa tients with GIST who have a par tic u lar
ge netic mu ta tion are more likely to re spond to Glivec than those with out the mu ta tion. The re sults con -
firm pre vi ous ob ser va tions and pro vide a foun da tion for mo lec u lar test ing that can pre dict who will best
re spond to treatment with the product.
In 2006, Glivec’s la bel was up dated to in clude re ports of se vere con ges tive heart fail ure and left ven tric u -
lar dys func tion. This pre cau tion could have a neg a tive im pact on future sales.
Clin i cal Data: The piv otal study for Glivec was the IRIS (In ter na tional Ran dom ized study of In ter feron
vs. STI 571) trial, which took place at 177 cen ters in 16 coun tries, com par ing imatinib with stan dard al -
pha in ter feron plus cytarabine as first line ther apy in 1,106 pa tients with newly di ag nosed Bcr-Abl pos i -
tive CML. Data was pre sented from this trial in Jan u ary 2002 (pre lim i nary re sults), De cem ber 2002 (18
month data) and De cem ber 2004 (42 month data). All the data was highly pos i tive, with ini tial re sults
show ing that pa tients treated with imatinib, 77% showed com plete or ma jor cytogenetic re sponses, with
a hematological response rate of 98%.
Data pre sented at the 2006 ASCO meet ing showed that 89% of CML pa tients who were treated with
Glivec were alive af ter five years, com pared to no more than 50% sur vival rate with other ther a pies. In
Jan u ary 2009 Novartis noted that data from the IRIS trial showed that nearly 90% of CML pa tients in the
study were still alive seven years af ter di ag no sis fol low ing treat ment with Glivec: this is the lon gest over -
all sur vival ob served to date in this disease.
In 2006, Novartis an nounced re sults from pre clin i cal stud ies of imatinib for the treat ment of rheu ma toid
ar thri tis. In vivo stud ies showed that imatinib damped down sev eral as pects of the im mune sys tem, in -
clud ing tu mor ne cro sis fac tor-al pha re lease, macrophage and mast cell pro duc tion, and pro duc tion of
B-cells; cells known to build up in the joints of pa tients with rheumatoid arthritis.
In Oc to ber 2008, Novartis re ported pre lim i nary re sults from a phase II proof-of-con cept study of imatinib
in the treat ment of pul mo nary ar te rial hy per ten sion (PAH). The dou ble-blind, pla cebo-con trolled,
multicenter trial en rolled 59 pa tients with PAH. The trial aimed to eval u ate the safety and ef fi cacy of 400
mg imatinib in pa tients who had pre vi ously failed to im prove fol low ing stan dard treat ment with
prostanoids, endothelin an tag o nists or PDE-V in hib i tors. Re sults showed a sig nif i cant im prove ment in
pul mo nary vas cu lar re sis tance and a nu mer i cal in crease in car diac out put. Im prove ments in the six-min -
ute walk test were observed but these did not reach statistical significance.
Pat ents: Pat ents run to 2013 in most mar kets (2016 in Aus tra lia) and 2016 in Eu rope.
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