IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES NOVARTIS
VADIMEZAN (ASA 404) is an an a logue of flavone ace tic acid with po ten tial for use in com bi na tion with
stan dard che mo ther apy in pa tients with var i ous can cers. Vadimezan was orig i nally de vel oped by
Antisoma (UK), which li censed it to Novartis in 2007.
In April 2008, Antisoma stated that its de vel op ment part ner, Novartis, has be gun a ran dom ized, dou -
ble-blind, pla cebo-con trolled, in ter na tional phase III trial of ASA 404, com bined with first-line che mo -
ther apy, in the treat ment of nonsmall cell lung can cer (NSCLC). This study, des ig nated AT TRACT-1, will
en roll 1200 pa tients who will be ran dom ized 1:1 to re ceive ei ther ASA 404 1800 mg/m2 plus che mo ther -
apy (carboplatin/paclitaxel) or pla cebo plus the same che mo ther apy as a con trol. Over all sur vival will be
the pri mary end point. Sec ond ary end points in clude sur vival in the squamous and non-squamous pa tient
sub groups. Pend ing suc cess ful re sults, Antisoma ex pects to submit regulatory applications in 2011.
In Au gust 2008, Antisoma an nounced sur vival data from its phase II study of vadimezan in hor mone-re -
frac tory pros tate can cer, in which pa tients were ran dom ized to re ceive ei ther 1,200mg/m2 vadimezan
plus the che mo ther apy drug docetaxel or a con trol treat ment of docetaxel alone. The haz ard ra tio ex -
press ing the rel a tive risk of death in the vadimezan and con trol groups fa vored the vadimezan group. Me -
dian sur vival in the two groups was sim i lar at 17.0 and 17.2 months re spec tively, while two-year sur vival
was 33% with vadimezan and 23% in the con trol group. Pre vi ously re ported find ings from the same trial
have shown higher tu mor re sponse rates and mark edly higher PSA re sponse rates in patients receiving
vadimezan.
Li cens ing: In 2007, Antisoma signed an ex clu sive global li cens ing deal with Novartis re lat ing to
vadimezan. Un der the terms of the deal, Novartis is re spon si ble to fund and con duct all fu ture de vel op -
ment of vadimezan, as well as to fund the out stand ing costs of the phase II tri als be ing com pleted by
Antisoma. Antisoma is el i gi ble to re ceive to tal upfront, de vel op ment, reg u la tory and sales-re lated mile -
stone pay ments of $890 mil lion, de pend ing on the suc cess ful de vel op ment and mar ket ing of vadimezan
and backup prod ucts in mul ti ple in di ca tions. Ad di tion ally, vadimezan is ap proved and com mer cial ized,
Antisoma will re ceive roy al ties on sales; Antisoma will have an option to co-market in the USA.
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 ($100 mil lion in 2013).
AUY 922 is a syn thetic Hsp90 in hib i tor, be ing de vel oped by Novartis and Vernalis for the po ten tial treat -
ment of can cer. In 2007, Novartis ini ti ated a phase I/II trial of AUY 922 in the treat ment of solid ma lig -
nan cies; the phase II ex ten sion arm of this trial will in clude pa tients with breast can cer. In late 2008,
Novartis be gan the phase I part of an open-la bel phase I/II trial of iv AUY 922 in com bi na tion with
bortezomib with or with out dexa meth a sone in re lapsed or refractory multiple myeloma.
GIMATECAN (LBQ 707/ST 1481) is a camptothecin an a logue (DNA topoisomerase in hib i tor), orig i nally
de vel oped by Sigma-Tau (It aly). In 2003, Novartis gained world wide de vel op ment and com mer cial iza -
tion rights to gimatecan from Sigma-Tau. Un der the terms of the deal, Sigma-Tau re tains co-mar ket ing
rights in It aly and will re ceive an upfront pay ment and de vel op ment mile stone pay ments from Novartis
as well as roy al ties on world wide sales of the prod uct. In 2005, it was re ported to be un der go ing phase II
tri als in the USA for the treat ment of pa tients with re cur rent or re frac tory ma lig nant glioma. Novartis ex -
pects to file for approval in the USA in or after 2011.
In May 2007, Novartis ini ti ated a safety/ef fi cacy phase I trial of gimatecan in Ja pan for the po ten tial treat -
ment of solid tu mors. The study is eval u at ing gimatecan ad min is tered orally twice per week ev ery 28
days to Jap a nese pa tients with ad vanced solid tu mors. Novartis plans to en roll 34 pa tients and pri mary
out come mea sures in clude the safety and tolerability as sessed by ad verse events char ac ter iza tion of the
pharmacokinetic pro file of gimatecan antitumor ac tiv ity as sessed by Re sponse Eval u a tion Criteria in Solid
Tumors (RECIST).
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