IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
Clin i cal Data: In Au gust 2008, IMS R&D Fo cus re ported that a US ran dom ized, dou ble-blind, pla -
cebo-con trolled phase III trial of in duc tion che mo ther apy (daunorubicin/cytarabine) and con sol i da tion
che mo ther apy (high-dose cytarabine) plus midostaurin or pla cebo has ini ti ated in the USA in ap prox i -
mately 514 newly di ag nosed pa tients with FLT3 mu tated acute myeloid leu ke mia (AML). The pri mary
end point of the trial is to de ter mine over all sur vival. Sec ond ary out come mea sures in clude: re sponse
rate, event-free sur vival, dis ease-free sur vival and dis ease-free sur vival one year af ter completion of the
planned continuation phase.
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 ($75 mil lion in 2013).
PASIREOTIDE (SOM 230), a somatostatin an a logue, is in phase III tri als. It has po ten tial in the treat -
ment of acromegaly, carcinoid syn drome, Cush ing’s dis ease and gastroenteropancreatic (GEP)
neuroendocrine tu mors. Cush ing’s dis ease is a rare dis or der char ac ter ized by ex ces sive ex cre tion of the
hor mone cortisol from a pi tu itary adenoma (tu mor), a con di tion for which there is no approved medical
therapy.
In No vem ber 2007, Novartis ini ti ated a multicenter, ran dom ized, blinded phase III study in the USA to
as sess the safety and ef fi cacy of long-act ing re lease pasireotide ver sus long-act ing re lease octreotide in
330 pa tients with ac tive acromegaly. Pri mary out come mea sures will in clude mean growth hor mone lev -
els and in su lin like growth fac tor-1 (IGF-1) levels.
Novartis plans to file a NDA for the treat ment of re frac tory/re sis tant carcinoid syn drome in 2010 and for
the treat ment of acromegaly in 2011.
Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) fore cast ini tial sales of $50 mil lion in
2011 ($100 mil lion by 2013).
PATUPILONE (EPO 906 or epothilone B) is an epothilone microtubule poly mer iza tion pro moter and a
depolymerization in hib i tor in de vel op ment for the treat ment of solid tu mors. The com pound en tered
phase III tri als in the USA in 2005 for po ten tial use in the treat ment of ovar ian can cer. How ever, it has ex -
pe ri enced un ex pect edly slow pa tient ac crual for this trial, de lay ing sub mis sion. A pro to col amend ment
has been made and the num ber of cen ters ex panded. Phase II tri als in colorectal can cer, breast can cer,
re nal cell car ci noma and non-small cell lung can cer are also ongoing in the USA and Europe.
Epothilones are macrolides, pro duced by myxobacteria, that have the abil ity to in duce microtubule for -
ma tion and sta bi li za tion, ar rest ing the pro gres sion of the cell cy cle and in duc ing apoptosis. EPO 906 is un -
der in ves ti ga tion as an in tra ve nous for mu la tion. Novartis has fore cast a first filing in 2010.
Clin i cal Data: Phase II re sults for patupilone were pre sented at the Amer i can So ci ety of Clin i cal On col -
ogy An nual Meet ing in June 2008. In this US trial, patupilone was as sessed in 22 pa tients with breast can -
cer brain metastases pro gress ing or re cur ring af ter whole brain ra di a tion ther apy. The agent was well
tol er ated. No ther apy-re lated grade 4 or 5 ad verse events were ob served. Di ar rhea (71% of pa tients)
was the most com mon tox ic ity re ported. Fa tigue (63%), nau sea (45%), an orexia (22%), sen sory neu -
rop a thy (26%) and pain/head ache (27%) were also re ported. Three-month CNS pro gres sion-free sur -
vival was 32% (95%, CI 11-53%). Three pa tients achieved par tial re sponse, two pa tients had sta ble
dis ease and eleven had pro gres sive dis ease. Four pa tients are await ing assessment. Accrual in this trial is
still ongoing.
Sales/An a lyst Com ment: Cowen & Co an a lysts (au gust 2008) fore cast ini tial sales of $50 mil lion in
2011 ($100 mil lion by 2013)
© 2009 IMS Health In cor po rated or its af fil i ates Page 80